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Clinical Trial Results:
A Phase II, randomized, double-blind, placebo-controlled repeated-dose study to evaluate the efficacy, safety, tolerability, and PK/PD of intravenously administered MOR106 in adult subjects with moderate to severe atopic dermatitis

Summary
EudraCT number	2017-001142-10
Trial protocol	DE GB HU PL SK
Global end of trial date	03 Mar 2020

Results information
Results version number	v1(current)
This version publication date	23 Dec 2020
First version publication date	23 Dec 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

MOR106-CL-201

ISRCTN number

US NCT number

NCT03568071

WHO universal trial number (UTN)

Sponsor organisation name

Galapagos NV

Sponsor organisation address

Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800

Public contact

Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com

Scientific contact

Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

03 Mar 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 Mar 2020

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary objective of the study was to assess the clinical efficacy of repeated intravenous (IV) doses of MOR106 as assessed by percentage change from baseline in Eczema Area and Severity Index (EASI) score at Day 85 visit in adult subjects with moderate to severe atopic dermatitis (AD).

Protection of trial subjects

The study was performed in accordance with the ethical principles that have their origin in the “Declaration of Helsinki” and its amendments in force at the time of the study. It was also carried out in conformity with the protocol and International Council for Harmonisation Guideline for Good Clinical Practice (ICH-GCP) (EMA, 2002). The investigator informed the participants of the risks and benefits of the study. The participants were informed that they could withdraw from the study at any time for any reason. Consent was obtained in writing prior to any study-related activities; the investigator retained the inform consent forms (ICFs), which were available to Galapagos for inspection. In the case of the optional substudies (skin biopsy, target lesion photography, and genetic research), participant were be informed that choosing not to participate, will not affect their participation in the main study. The participant was given sufficient time to read the ICF and to ask additional questions. After this explanation and before entry in the clinical study, consent was appropriately recorded by means of the participant's personally dated signature and by the investigator’s signature. After having obtained the consent, a copy of the signed and dated informed consent(s) was given to the participant. The participants were covered by Galapagos insurance according to local legal requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

26 Apr 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 17

Country: Number of subjects enrolled

Hungary: 35

Country: Number of subjects enrolled

Poland: 150

Country: Number of subjects enrolled

United Kingdom: 5

Worldwide total number of subjects

207

EEA total number of subjects

207

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

205

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were enrolled at study sites in Poland, Hungary, Germany, and United Kingdom. The first subject was screened on 26 April 2018 and the last study visit happened on 03 March 2020.

Screening details

A total of 270 subjects were screened of which 207 were randomized and enrolled in the study.

Period 1 title

Overall Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Monitor, Data analyst, Carer, Assessor, Subject, Investigator

Are arms mutually exclusive

Yes

Placebo Q2W

Arm description

Subjects received MOR106 matching placebo, IV infusions, every 2 weeks (Q2W) up to Week 12.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Subject received Placebo Q2W up to Week 12.

MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Arm description

Subjects received MOR106 1 milligram per kilogram (mg/kg), IV infusions, every 4 weeks (Q4W) up to Week 12. A loading dose (LD) of 2 mg/kg was administered on Day 1.

Arm type

Experimental

Investigational medicinal product name

MOR106

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects received MOR106 1 mg/kg IV infusions, Q4W up to Week 12.

MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Arm description

Subjects received MOR106 3 mg/kg IV infusions, Q4W up to Week 12. A LD of 6 mg/kg was administered on Day 1.

Arm type

Experimental

Investigational medicinal product name

MOR106

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects received MOR106 3 mg/kg IV infusions, Q4W up to Week 12.

MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Arm description

Subjects received MOR106 1 mg/kg IV infusions, Q2W up to Week 12. A LD of 2 mg/kg was administered on Day 1.

Arm type

Experimental

Investigational medicinal product name

MOR106

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects received MOR106 1 mg/kg IV infusions, Q2W up to Week 12.

MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Arm description

Subjects received MOR106 3 mg/kg IV infusions, Q2W up to Week 12. A LD of 6 mg/kg was administered on Day 1.

Arm type

Experimental

Investigational medicinal product name

MOR106

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects received MOR106 3 mg/kg IV infusions, Q2W up to Week 12.

MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Arm description

Subjects received MOR106 10 mg/kg IV infusions, Q2W up to Week 12. A LD of 20 mg/kg was administered on Day 1.

Arm type

Experimental

Investigational medicinal product name

MOR106

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects received MOR106 10 mg/kg IV infusions, Q2W up to Week 12.

Number of subjects in period 1	Placebo Q2W	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1
Started	37	30	30	36	38	36
Completed	24	19	19	20	25	27
Not completed	13	11	11	16	13	9
Physician decision	1	-	1	-	1	-
Consent withdrawn by subject	9	5	4	9	9	6
Adverse event, non-fatal	1	3	5	4	2	1
Other	2	2	-	2	1	1
Lost to follow-up	-	1	-	1	-	-
Lack of efficacy	-	-	1	-	-	1

Baseline characteristics

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Reporting group title

Placebo Q2W

Reporting group description

Subjects received MOR106 matching placebo, IV infusions, every 2 weeks (Q2W) up to Week 12.

Reporting group title

MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 1 milligram per kilogram (mg/kg), IV infusions, every 4 weeks (Q4W) up to Week 12. A loading dose (LD) of 2 mg/kg was administered on Day 1.

Reporting group title

MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 3 mg/kg IV infusions, Q4W up to Week 12. A LD of 6 mg/kg was administered on Day 1.

Reporting group title

MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 1 mg/kg IV infusions, Q2W up to Week 12. A LD of 2 mg/kg was administered on Day 1.

Reporting group title

MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 3 mg/kg IV infusions, Q2W up to Week 12. A LD of 6 mg/kg was administered on Day 1.

Reporting group title

MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 10 mg/kg IV infusions, Q2W up to Week 12. A LD of 20 mg/kg was administered on Day 1.

Reporting group values	Placebo Q2W	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1	Total
Number of subjects	37	30	30	36	38	36	207
Age categorical
Units: Subjects
>=18 to <25	5	6	8	12	7	8	46
>=25 to <40	18	13	14	11	21	18	95
>=40 to <65	13	11	8	13	9	10	64
>=65	1	0	0	0	1	0	2
Age continuous
Units: years
arithmetic mean (standard deviation)	38.1 ± 12.67	35.6 ± 12.49	33.7 ± 12.24	35.1 ± 15.41	35.0 ± 12.58	33.8 ± 11.31	-
Gender categorical
Units: Subjects
Female	18	17	17	20	19	10	101
Male	19	13	13	16	19	26	106
Race
Units: Subjects
Asian	0	1	0	0	0	0	1
White	37	29	30	36	38	36	206
Ethnicity
Units: Subjects
Non Hispanic or Latino	37	30	30	36	38	36	207
Eczema Area and Severity Index (EASI)
Units: scores on scale
arithmetic mean (standard deviation)	29.201 ± 13.5282	28.482 ± 11.1545	27.372 ± 8.9842	28.956 ± 10.7465	28.962 ± 11.5183	34.264 ± 15.4456	-
Scoring Atopic Dermatitis (SCORAD) Score
Units: scores on scale
arithmetic mean (standard deviation)	67.662 ± 14.1537	67.087 ± 13.5887	60.800 ± 9.9124	66.248 ± 11.0225	63.907 ± 12.3086	68.624 ± 13.5505	-

End points

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Reporting group title

Placebo Q2W

Reporting group description

Subjects received MOR106 matching placebo, IV infusions, every 2 weeks (Q2W) up to Week 12.

Reporting group title

MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 1 milligram per kilogram (mg/kg), IV infusions, every 4 weeks (Q4W) up to Week 12. A loading dose (LD) of 2 mg/kg was administered on Day 1.

Reporting group title

MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 3 mg/kg IV infusions, Q4W up to Week 12. A LD of 6 mg/kg was administered on Day 1.

Reporting group title

MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 1 mg/kg IV infusions, Q2W up to Week 12. A LD of 2 mg/kg was administered on Day 1.

Reporting group title

MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 3 mg/kg IV infusions, Q2W up to Week 12. A LD of 6 mg/kg was administered on Day 1.

Reporting group title

MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 10 mg/kg IV infusions, Q2W up to Week 12. A LD of 20 mg/kg was administered on Day 1.

Primary: Percent Change From Baseline in EASI score At Day 85

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End point title

Percent Change From Baseline in EASI score At Day 85

End point description

The EASI is used to assess the severity and extent of AD. Four AD disease characteristics (erythema, induration/papulation, excoriation, and lichenification) is assessed for severity on a scale of 0 (absent) to 3 (severe). The area of AD involvement is assessed as a percentage by body area of head, trunk, arms, and legs, and converted to a score of 0 (0 percent [%]) to 6 (90-100%). The total EASI score for each region is calculated by multiplying the severity score by the area score. The EASI score ranges are between 0 and 72, where higher scores represent worse outcome. The EASI is assessed by the investigator or adequately qualified and trained designee at all timepoints. The full analysis set (FAS) included all randomized subjects who received/used at least 1 dose of investigational medicinal product (IMP), and had at least 1 post baseline efficacy assessment. FAS population with subjects available at specified time point.

End point type

Primary

End point timeframe

Baseline and Day 85

End point values	Placebo Q2W	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1
Number of subjects analysed	20	25	22	25	24	26
Units: percent change
least squares mean (standard error)	-22.09 ± 9.447	-36.24 ± 9.065	-32.60 ± 9.494	-42.97 ± 8.942	-40.18 ± 9.130	-37.00 ± 8.902

Day 85: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a mixed effect model repeat measurement (MMRM) approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline EASI score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2488

Method

MMRM

Parameter type

LS mean difference

Point estimate

-14.15

Confidence interval

level

95%

sides

2-sided

lower limit

-38.29

upper limit

Variability estimate

Standard error of the mean

Dispersion value

12.22

Day 85: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline EASI score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4021

Method

MMRM

Parameter type

LS mean difference

Point estimate

-10.51

Confidence interval

level

95%

sides

2-sided

lower limit

-35.23

upper limit

14.2

Variability estimate

Standard error of the mean

Dispersion value

12.511

Day 85: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0842

Method

MMRM

Parameter type

LS mean difference

Point estimate

-20.88

Confidence interval

level

95%

sides

2-sided

lower limit

-44.62

upper limit

2.85

Variability estimate

Standard error of the mean

Dispersion value

12.014

Day 85: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1396

Method

MMRM

Parameter type

LS mean difference

Point estimate

-18.09

Confidence interval

level

95%

sides

2-sided

lower limit

-42.14

upper limit

5.97

Variability estimate

Standard error of the mean

Dispersion value

12.179

Day 85: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2179

Method

MMRM

Parameter type

LS mean difference

Point estimate

-14.91

Confidence interval

level

95%

sides

2-sided

lower limit

-38.71

upper limit

8.89

Variability estimate

Standard error of the mean

Dispersion value

12.05

Secondary: Percentage of Subjects who Achieved >=50% Overall improvement in EASI Score From Baseline

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End point title

Percentage of Subjects who Achieved >=50% Overall improvement in EASI Score From Baseline

End point description

Percentage of participants who achieved at least a 50% improvement in EASI score were reported. The EASI is used to assess the severity and extent of AD. Four AD disease characteristics (erythema, induration/papulation, excoriation, and lichenification) is assessed for severity on a scale of 0 (absent) to 3 (severe). The area of AD involvement is assessed as a percentage by body area of head, trunk, arms, and legs, and converted to a score of 0 (0%) to 6 (90-100%). The total EASI score for each region is calculated by multiplying the severity score by the area score. The EASI score ranges are between 0 and 72, where higher scores represent worse outcome. The EASI is assessed by the investigator or adequately qualified and trained designee at all timepoints. FAS population with subjects available at specified time point.

End point type

Secondary

End point timeframe

Baseline, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85

End point values	Placebo Q2W	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1
Number of subjects analysed	35	30	30	36	35	35
Units: percentage of subjects
number (not applicable)
Day 15 (n= 35, 30, 30, 36, 35, 35)	11.4	13.3	3.3	8.3	8.6	14.3
Day 29 (n= 33, 28, 28, 33, 33, 35)	18.2	17.9	25.0	30.3	24.2	34.3
Day 43 (n= 27, 28, 26, 31, 31, 28)	14.8	32.1	34.6	29.0	41.9	32.1
Day 57 (n= 25, 27, 24, 29, 27, 27)	28.0	40.7	41.7	34.5	59.3	63
Day 71 (n= 23, 26, 23, 27, 24, 25)	34.8	50.0	65.2	55.6	62.5	56
Day 85 (n= 20, 25, 22, 25, 24, 26)	40.0	48.0	63.6	64.0	66.7	61.5

Day 15: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a generalized estimating equations (GEE) model for binary data using SAS GENMOD procedure with a logit link, binomial distribution and independent within-subject correlation matrix with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline EASI score and country as covariates and treatment-visit as interaction terms. The model was implemented with multiple imputation for missing data in all participants of the FAS.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7669

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.25

Confidence interval

level

95%

sides

2-sided

lower limit

0.28

upper limit

5.53

Day 15: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a GEE model for binary data using SAS GENMOD procedure with a logit link, binomial distribution and independent within-subject correlation matrix with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline EASI score and country as covariates and treatment-visit as interaction terms. The model was implemented with multiple imputation for missing data in all participants of the FAS.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.27

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

0.03

upper limit

2.68

Day 15: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6946

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

0.73

Confidence interval

level

95%

sides

2-sided

lower limit

0.15

upper limit

3.53

Day 15: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7149

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

0.16

upper limit

3.55

Day 15: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6402

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.34

upper limit

5.75

Day 29: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9308

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

0.94

Confidence interval

level

95%

sides

2-sided

lower limit

0.25

upper limit

3.51

Day 29: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5636

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.44

Confidence interval

level

95%

sides

2-sided

lower limit

0.42

upper limit

4.99

Day 29: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2882

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.88

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

6.06

Day 29: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1 v Placebo Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5885

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.39

Confidence interval

level

95%

sides

2-sided

lower limit

0.42

upper limit

4.62

Day 29: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1125

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.52

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

7.89

Day 43: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1643

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.52

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

9.31

Day 43: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1385

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

10.05

Day 43: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2456

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.13

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

7.68

Day 43: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0442

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

3.6

Confidence interval

level

95%

sides

2-sided

lower limit

1.03

upper limit

12.57

Day 43: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1623

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.45

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

8.58

Day 57: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2401

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.97

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

6.1

Day 57: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.316

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.81

Confidence interval

level

95%

sides

2-sided

lower limit

0.57

upper limit

5.76

Day 57: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5219

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.46

Confidence interval

level

95%

sides

2-sided

lower limit

0.46

upper limit

4.65

Day 57: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0482

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

3.12

Confidence interval

level

95%

sides

2-sided

lower limit

1.01

upper limit

9.63

Day 57: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0232

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

3.67

Confidence interval

level

95%

sides

2-sided

lower limit

1.19

upper limit

11.27

Day 71: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2087

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.02

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

6.03

Day 71: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0726

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.73

Confidence interval

level

95%

sides

2-sided

lower limit

0.91

upper limit

8.15

Day 71: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1735

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.72

upper limit

6.11

Day 71: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.137

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.28

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

6.79

Day 71: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1921

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.05

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

6.01

Day 85: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4846

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.48

upper limit

4.74

Day 85: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2074

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.11

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

6.71

Day 85: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1725

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.13

Confidence interval

level

95%

sides

2-sided

lower limit

0.72

upper limit

6.34

Day 85: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1671

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

7.51

Day 85: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1622

Method

GEE model

Parameter type

Odds ratio (OR)

Point estimate

2.23

Confidence interval

level

95%

sides

2-sided

lower limit

0.72

upper limit

6.9

Secondary: Percentage of Subjects who Achieved an Investigators' Global Assessment (IGA) score of 0 or 1

Top of page

End point title

Percentage of Subjects who Achieved an Investigators' Global Assessment (IGA) score of 0 or 1

End point description

The IGA is used to assess the severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 to 4, where 0: clear (no inflammatory signs of AD), 1: almost clear (just perceptible erythema and just perceptible papulation/infiltration), 2: mild (mild erythema and mild papulation/infiltration), 3: moderate (moderate erythema and moderate papulation/infiltration), and 4: severe (severe erythema and severe papulation/infiltration with or without oozing/crusting). The EASI is assessed by the investigator or adequately qualified and trained designee at all timepoints. The percentage of subjects with a score of 0 or 1 is reported. FAS population with subjects available at specified timepoint.

End point type

Secondary

End point timeframe

Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85

End point values	Placebo Q2W	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1
Number of subjects analysed	35	30	30	36	35	35
Units: percentage of subjects
number (not applicable)
Day 15 (n= 35, 30, 30, 36, 35, 35)	2.9	0	0	0	0	0
Day 29 (n= 33, 28, 28, 33, 33, 35)	3.0	0	0	0	0	2.9
Day 43 (n= 27, 28, 26, 31, 31, 28)	0	0	3.8	0	0	14.3
Day 57 (n= 25, 27, 24, 29, 27, 27)	4.4	0	12.5	6.9	0	14.8
Day 71 (n= 23, 26, 23, 27, 24, 25)	4.3	7.7	13	11.1	8.3	16.0
Day 85 (n= 20, 25, 22, 25, 24, 26)	20.0	20.0	31.8	12.0	11.5	11.5

No statistical analyses for this end point

Secondary: Percent Change From Baseline in SCORAD Score

Top of page

End point title

Percent Change From Baseline in SCORAD Score

End point description

The SCORAD is used to evaluate extent and severity of AD. Extent of AD is assessed as percentage of each defined body area and reported as sum of all areas, with maximum score of 100% (A in overall SCORAD calculation). The severity of 6 specific symptoms of AD is assessed using following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points, B in overall SCORAD calculation). Subjective assessment of itch and sleeplessness is recorded for each symptom by the subject/relative on a visual analogue scale, where 0 is no itch (or sleeplessness) and 10 is worst imaginable itch (or sleeplessness), with a maximum possible score of 20 (C in overall SCORAD calculation). The SCORAD is calculated as: A/5 + 7B/2 + C and ranges between 0 and 103, where higher scores represent worse outcome. The SCORAD is assessed by the investigator or adequately qualified and trained designee at all timepoints. FAS population with subjects available at specified timepoints.

End point type

Secondary

End point timeframe

Baseline, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85

End point values	Placebo Q2W	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1
Number of subjects analysed	35	30	30	36	35	35
Units: percent change
least squares mean (standard error)
Day 15 (n= 35, 30, 30, 36, 35, 35)	-2.13 ± 3.811	-9.93 ± 4.019	-3.36 ± 3.984	-5.47 ± 3.930	-2.24 ± 3.949	-8.41 ± 3.825
Day 29 (n= 33, 28, 28, 33, 33, 35)	-8.70 ± 4.450	-8.40 ± 4.679	-11.67 ± 4.706	-13.08 ± 4.541	-11.39 ± 4.533	-17.99 ± 4.362
Day 43 (n= 27, 28, 26, 31, 31, 28)	-10.01 ± 5.130	-14.01 ± 5.156	-11.88 ± 5.293	-16.48 ± 5.036	-19.97 ± 5.012	-19.64 ± 5.015
Day 57 (n= 25, 27, 24, 29, 27, 27)	-16.0 ± 5.686	-25.22 ± 5.596	-16.62 ± 5.828	-19.79 ± 5.488	-29.81 ± 5.544	-30.22 ± 5.504
Day 71 (n= 23, 26, 23, 27, 24, 25)	-18.55 ± 6.291	-30.50 ± 6.112	-24.51 ± 6.397	-26.69 ± 6.002	-26.22 ± 6.148	-30.99 ± 6.054
Day 85 (n= 20, 25, 22, 25, 24, 26)	-23.49 ± 6.658	-31.90 ± 6.372	-29.18 ± 6.669	-32.94 ± 6.286	-33.54 ± 6.410	-28.97 ± 6.235

Day 15: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0874

Method

MMRM

Parameter type

LS mean difference

Point estimate

-7.81

Confidence interval

level

95%

sides

2-sided

lower limit

-16.77

upper limit

1.16

Variability estimate

Standard error of the mean

Dispersion value

4.544

Day 15: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7885

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.23

Confidence interval

level

95%

sides

2-sided

lower limit

-10.29

upper limit

7.82

Variability estimate

Standard error of the mean

Dispersion value

4.591

Day 15: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4422

Method

MMRM

Parameter type

LS mean difference

Point estimate

-3.34

Confidence interval

level

95%

sides

2-sided

lower limit

-11.91

upper limit

5.22

Variability estimate

Standard error of the mean

Dispersion value

4.342

Day 15: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9793

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-8.75

upper limit

8.53

Variability estimate

Standard error of the mean

Dispersion value

4.381

Day 15: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1514

Method

MMRM

Parameter type

LS mean difference

Point estimate

-6.29

Confidence interval

level

95%

sides

2-sided

lower limit

-14.9

upper limit

2.32

Variability estimate

Standard error of the mean

Dispersion value

4.365

Day 29: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9583

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-10.75

upper limit

11.34

Variability estimate

Standard error of the mean

Dispersion value

5.598

Day 29: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5996

Method

MMRM

Parameter type

LS mean difference

Point estimate

-2.97

Confidence interval

level

95%

sides

2-sided

lower limit

-14.13

upper limit

8.18

Variability estimate

Standard error of the mean

Dispersion value

5.655

Day 29: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4157

Method

MMRM

Parameter type

LS mean difference

Point estimate

-4.38

Confidence interval

level

95%

sides

2-sided

lower limit

-14.98

upper limit

6.22

Variability estimate

Standard error of the mean

Dispersion value

0.4157

Day 29: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6185

Method

MMRM

Parameter type

LS mean difference

Point estimate

-2.69

Confidence interval

level

95%

sides

2-sided

lower limit

-13.32

upper limit

7.95

Variability estimate

Standard error of the mean

Dispersion value

5.391

Day 29: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0829

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9.29

Confidence interval

level

95%

sides

2-sided

lower limit

-19.8

upper limit

1.22

Variability estimate

Standard error of the mean

Dispersion value

5.328

Day 43: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5383

Method

MMRM

Parameter type

LS mean difference

Point estimate

-4.01

Confidence interval

level

95%

sides

2-sided

lower limit

-16.83

upper limit

8.82

Variability estimate

Standard error of the mean

Dispersion value

6.496

Day 43: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7779

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.87

Confidence interval

level

95%

sides

2-sided

lower limit

-14.95

upper limit

11.21

Variability estimate

Standard error of the mean

Dispersion value

6.626

Day 43: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3057

Method

MMRM

Parameter type

LS mean difference

Point estimate

-6.48

Confidence interval

level

95%

sides

2-sided

lower limit

-18.92

upper limit

5.97

Variability estimate

Standard error of the mean

Dispersion value

6.305

Day 43: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1165

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9.96

Confidence interval

level

95%

sides

2-sided

lower limit

-22.42

upper limit

2.5

Variability estimate

Standard error of the mean

Dispersion value

6.313

Day 43: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1312

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9.64

Confidence interval

level

95%

sides

2-sided

lower limit

-22.18

upper limit

2.9

Variability estimate

Standard error of the mean

Dispersion value

6.354

Day 57: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2069

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9.2

Confidence interval

level

95%

sides

2-sided

lower limit

-23.54

upper limit

5.14

Variability estimate

Standard error of the mean

Dispersion value

7.258

Day 57: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9359

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-15.32

upper limit

14.12

Variability estimate

Standard error of the mean

Dispersion value

7.455

Day 57: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5959

Method

MMRM

Parameter type

LS mean difference

Point estimate

-3.77

Confidence interval

level

95%

sides

2-sided

lower limit

-17.77

upper limit

10.24

Variability estimate

Standard error of the mean

Dispersion value

7.09

Day 57: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0561

Method

MMRM

Parameter type

LS mean difference

Point estimate

-13.79

Confidence interval

level

95%

sides

2-sided

lower limit

-27.93

upper limit

0.36

Variability estimate

Standard error of the mean

Dispersion value

7.165

Day 57: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0488

Method

MMRM

Parameter type

LS mean difference

Point estimate

-14.2

Confidence interval

level

95%

sides

2-sided

lower limit

-28.32

upper limit

-0.08

Variability estimate

Standard error of the mean

Dispersion value

7.152

Day 71: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1428

Method

MMRM

Parameter type

LS mean difference

Point estimate

-11.95

Confidence interval

level

95%

sides

2-sided

lower limit

-27.98

upper limit

4.08

Variability estimate

Standard error of the mean

Dispersion value

8.113

Day 71: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4757

Method

MMRM

Parameter type

LS mean difference

Point estimate

-5.96

Confidence interval

level

95%

sides

2-sided

lower limit

-22.44

upper limit

10.51

Variability estimate

Standard error of the mean

Dispersion value

8.341

Day 71: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3076

Method

MMRM

Parameter type

LS mean difference

Point estimate

-8.14

Confidence interval

level

95%

sides

2-sided

lower limit

-23.85

upper limit

7.57

Variability estimate

Standard error of the mean

Dispersion value

7.954

Day 71: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3442

Method

MMRM

Parameter type

LS mean difference

Point estimate

-7.68

Confidence interval

level

95%

sides

2-sided

lower limit

-23.66

upper limit

8.31

Variability estimate

Standard error of the mean

Dispersion value

8.093

Day 71: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1233

Method

MMRM

Parameter type

LS mean difference

Point estimate

-12.45

Confidence interval

level

95%

sides

2-sided

lower limit

-28.32

upper limit

3.42

Variability estimate

Standard error of the mean

Dispersion value

8.033

Day 85: MOR106 1 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3304

Method

MMRM

Parameter type

LS mean difference

Point estimate

-8.4

Confidence interval

level

95%

sides

2-sided

lower limit

-25.41

upper limit

8.6

Variability estimate

Standard error of the mean

Dispersion value

8.607

Day 85: MOR106 3 mg/kg Q4W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.521

Method

MMRM

Parameter type

LS mean difference

Point estimate

-5.69

Confidence interval

level

95%

sides

2-sided

lower limit

-23.16

upper limit

11.78

Variability estimate

Standard error of the mean

Dispersion value

8.845

Day 85: MOR106 1 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2665

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9.45

Confidence interval

level

95%

sides

2-sided

lower limit

-26.18

upper limit

7.29

Variability estimate

Standard error of the mean

Dispersion value

8.472

Day 85: MOR106 3 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2441

Method

MMRM

Parameter type

LS mean difference

Point estimate

-10.04

Confidence interval

level

95%

sides

2-sided

lower limit

-27.01

upper limit

6.92

Variability estimate

Standard error of the mean

Dispersion value

8.588

Day 85: MOR106 10 mg/kg Q2W vs Placebo Q2W

Statistical analysis description

The analysis is performed with a MMRM approach using SAS mixed procedure, with treatment and visit up to Day 85 (defined by the time windows) as categorical fixed effects, baseline SCORAD score and country as covariates, treatment-visit as interaction terms and unstructured within-subject correlation matrix.

Comparison groups

Placebo Q2W v MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5195

Method

MMRM

Parameter type

LS mean difference

Point estimate

-5.48

Confidence interval

level

95%

sides

2-sided

lower limit

-22.23

upper limit

11.28

Variability estimate

Standard error of the mean

Dispersion value

8.482

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)

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End point title

Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)

End point description

Adverse events of special interest (AESIs) were defined as skin-related events (SRE) (except exacerbation and infective exacerbation of AD) or infusion-related reactions (IRR) (common terminology criteria for adverse events [CTCAE] Grade 2 to 5). The safety analysis population included all randomized subjects who received/used at least 1 dose of IMP or placebo.

End point type

Secondary

End point timeframe

Baseline up to Day 197/early discontinuation (ED)

End point values	Placebo Q2W	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1
Number of subjects analysed	37	30	30	36	38	36
Units: subjects
TEAE	26	27	22	22	29	26
IRR	0	1	0	1	0	1
SRE	1	4	3	1	7	8
SAE	2	5	3	4	1	2
Discontinuation due to AEs	3	4	6	5	2	2

No statistical analyses for this end point

Secondary: Number of Subjects with Anti-drug Antibodies (ADAs)

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End point title

Number of Subjects with Anti-drug Antibodies (ADAs)

End point description

Subjects with ADAs were reported. Safety Population.

End point type

Secondary

End point timeframe

Baseline up to Day 197/early discontinuation (ED)

End point values	Placebo Q2W	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1
Number of subjects analysed	37	30	30	36	38	36
Units: subjects	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Area Under the Concentration-time Curve From Zero to Infinity (AUC0-inf) for MOR106

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End point title

Area Under the Concentration-time Curve From Zero to Infinity (AUC0-inf) for MOR106 ^[1]

End point description

The pharmacokinetic (PK) analysis population was a subset of safety analysis set and included all subjects who had available and evaluable serum concentration data.

End point type

Secondary

End point timeframe

Day 1 to 197: Pre-infusion and 1 hour post-infusion

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was assessed only for the reporting groups in which participants received MOR106.

End point values	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1
Number of subjects analysed	0 ^[2]	0 ^[3]	0 ^[4]	0 ^[5]	0 ^[6]
Units: nanogramhour per milliliter (nghr/mL)
arithmetic mean (standard deviation)	±	±	±	±	±

Notes
[2] - Study treatment was discontinued prematurely, hence derivation of PK parameters was not performed.
[3] - Study treatment was discontinued prematurely, hence derivation of PK parameters was not performed.
[4] - Study treatment was discontinued prematurely, hence derivation of PK parameters was not performed.
[5] - Study treatment was discontinued prematurely, hence derivation of PK parameters was not performed.
[6] - Study treatment was discontinued prematurely, hence derivation of PK parameters was not performed.

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Day 1 up to Day 197/ED

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 1 mg/kg IV infusions, Q2W up to Week 12. A LD of 2 mg/kg was administered on Day 1.

Reporting group title

MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 1 mg/kg, IV infusions, Q4W up to Week 12. A LD of 2 mg/kg was administered on Day 1.

Reporting group title

MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 10 mg/kg IV infusions, Q2W up to Week 12. A LD of 20 mg/kg was administered on Day 1.

Reporting group title

MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 3 mg/kg IV infusions, Q2W up to Week 12. A LD of 6 mg/kg was administered on Day 1.

Reporting group title

MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1

Reporting group description

Subjects received MOR106 3 mg/kg IV infusions, Q4W up to Week 12. A LD of 6 mg/kg was administered on Day 1.

Reporting group title

Placebo Q2W

Reporting group description

Subjects received MOR106 matching placebo, IV infusions, Q2W up to Week 12.

Serious adverse events	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	Placebo Q2W
Total subjects affected by serious adverse events
subjects affected / exposed	4 / 36 (11.11%)	5 / 30 (16.67%)	2 / 36 (5.56%)	1 / 38 (2.63%)	3 / 30 (10.00%)	2 / 37 (5.41%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Injury, poisoning and procedural complications
Infusion related reaction
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	2 / 36 (5.56%)	2 / 30 (6.67%)	1 / 36 (2.78%)	1 / 38 (2.63%)	2 / 30 (6.67%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	1 / 2	1 / 2	1 / 1	1 / 1	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermatitis exfoliative generalised
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Connective tissue inflammation
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eczema herpeticum
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	MOR106 1 mg/kg Q2W + 2 mg/kg LD Day 1	MOR106 1 mg/kg Q4W + 2 mg/kg LD Day 1	MOR106 10 mg/kg Q2W + 20 mg/kg LD Day 1	MOR106 3 mg/kg Q2W + 6 mg/kg LD Day 1	MOR106 3 mg/kg Q4W + 6 mg/kg LD Day 1	Placebo Q2W
Total subjects affected by non serious adverse events
subjects affected / exposed	23 / 36 (63.89%)	26 / 30 (86.67%)	28 / 36 (77.78%)	29 / 38 (76.32%)	22 / 30 (73.33%)	26 / 37 (70.27%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Skin papilloma
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Vascular disorders
Haematoma
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Hypertension
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	1	0	1	0	0	1
Thrombophlebitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	0	2
Varicose vein
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Surgical and medical procedures
Tooth extraction
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	1	0	0	0
Fatigue
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	1 / 30 (3.33%)	1 / 37 (2.70%)
occurrences all number	0	0	0	1	2	2
Induration
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Influenza like illness
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	2 / 38 (5.26%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0	0
Localised oedema
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Oedema peripheral
subjects affected / exposed	2 / 36 (5.56%)	1 / 30 (3.33%)	2 / 36 (5.56%)	1 / 38 (2.63%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	2	2	2	1	0	1
Pain
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Peripheral swelling
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	2	0	0	0	0
Soft tissue inflammation
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	2 / 36 (5.56%)	2 / 38 (5.26%)	0 / 30 (0.00%)	3 / 37 (8.11%)
occurrences all number	0	0	2	2	0	3
Cough
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	1	0	0	0
Nasal congestion
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Nasal polyps
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	2	0	0	0	0
Nasal septum deviation
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Oropharyngeal pain
subjects affected / exposed	1 / 36 (2.78%)	1 / 30 (3.33%)	0 / 36 (0.00%)	2 / 38 (5.26%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	1	0	2	0	0
Rhinitis allergic
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	0 / 38 (0.00%)	2 / 30 (6.67%)	1 / 37 (2.70%)
occurrences all number	0	1	1	0	2	1
Rhinorrhoea
subjects affected / exposed	1 / 36 (2.78%)	1 / 30 (3.33%)	1 / 36 (2.78%)	2 / 38 (5.26%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	1	2	2	0	0
Sinus pain
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	2	0	0	0	0
Sneezing
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Tonsillar inflammation
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
Upper respiratory tract inflammation
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Psychiatric disorders
Depressed mood
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	0	0	0
Generalised anxiety disorder
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
Insomnia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	1	0	2
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	2	0	3	0	2
Aspartate aminotransferase increased
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	2 / 38 (5.26%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	1	1	2	0	1
Blood bilirubin increased
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Blood creatinine increased
subjects affected / exposed	2 / 36 (5.56%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	2 / 37 (5.41%)
occurrences all number	2	0	0	0	0	2
Blood immunoglobulin E increased
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	0 / 38 (0.00%)	1 / 30 (3.33%)	1 / 37 (2.70%)
occurrences all number	0	1	1	0	1	1
Blood phosphorus increased
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Blood potassium increased
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Blood pressure increased
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Blood triglycerides increased
subjects affected / exposed	1 / 36 (2.78%)	1 / 30 (3.33%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	2	2	0	0	0
Blood uric acid increased
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	1	0
Body temperature increased
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	0	0	0
C-reactive protein abnormal
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
C-reactive protein increased
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	2 / 36 (5.56%)	0 / 38 (0.00%)	1 / 30 (3.33%)	2 / 37 (5.41%)
occurrences all number	0	0	3	0	1	3
Electrocardiogram ST segment depression
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
Electrocardiogram ST segment elevation
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Electrocardiogram ST-T segment depression
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Electrocardiogram T wave inversion
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Eosinophil count increased
subjects affected / exposed	1 / 36 (2.78%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	2 / 30 (6.67%)	1 / 37 (2.70%)
occurrences all number	2	1	0	1	2	1
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 36 (0.00%)	2 / 30 (6.67%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	3	0	1	0	0
Heart rate increased
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Lymphocyte count decreased
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	3	1	1	0	0
N-terminal prohormone brain natriuretic peptide increased
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Platelet count increased
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	1 / 36 (2.78%)	1 / 38 (2.63%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	1	0	1	1	1	0
Protein urine
subjects affected / exposed	2 / 36 (5.56%)	1 / 30 (3.33%)	1 / 36 (2.78%)	1 / 38 (2.63%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	3	1	2	1	1	0
Red blood cells urine
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	2	1	0	0
Red blood cells urine positive
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
White blood cell count decreased
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
White blood cell count increased
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
White blood cells urine positive
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Fibula fracture
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Infusion related reaction
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Joint dislocation
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Ligament sprain
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Nail injury
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Procedural nausea
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Procedural pain
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Road traffic accident
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Traumatic haematoma
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Cardiac disorders
Arrhythmia supraventricular
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Bradycardia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Conduction disorder
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Sinus bradycardia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Headache
subjects affected / exposed	1 / 36 (2.78%)	4 / 30 (13.33%)	2 / 36 (5.56%)	4 / 38 (10.53%)	7 / 30 (23.33%)	4 / 37 (10.81%)
occurrences all number	2	5	2	6	8	9
Paraesthesia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Syncope
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Blood and lymphatic system disorders
Eosinophilia
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	0	0	0
Iron deficiency anaemia
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Leukopenia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Lymphadenopathy
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	2 / 38 (5.26%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	3	0	0
Lymphopenia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Neutropenia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Ear and labyrinth disorders
Cerumen impaction
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Ear discomfort
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
External ear inflammation
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Eye disorders
Conjunctivitis allergic
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	1	1	0	1
Swelling of eyelid
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 36 (2.78%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	1	1	0	2	0	1
Abdominal pain upper
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	2	0	0	0	0	1
Cheilosis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	1	0	0
Constipation
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Diarrhoea
subjects affected / exposed	1 / 36 (2.78%)	1 / 30 (3.33%)	1 / 36 (2.78%)	1 / 38 (2.63%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	2	1	1	1	1	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Inguinal hernia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Irritable bowel syndrome
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Noninfective gingivitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Toothache
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	1	0	0
Vomiting
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	1	0
Hepatobiliary disorders
Gallbladder polyp
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	2 / 36 (5.56%)	1 / 38 (2.63%)	2 / 30 (6.67%)	0 / 37 (0.00%)
occurrences all number	0	1	2	1	4	0
Alopecia
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	1 / 30 (3.33%)	1 / 37 (2.70%)
occurrences all number	0	1	0	1	1	1
Dermatitis
subjects affected / exposed	1 / 36 (2.78%)	1 / 30 (3.33%)	0 / 36 (0.00%)	2 / 38 (5.26%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	1	0	3	0	0
Dermatitis allergic
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Dermatitis atopic
subjects affected / exposed	9 / 36 (25.00%)	10 / 30 (33.33%)	17 / 36 (47.22%)	13 / 38 (34.21%)	14 / 30 (46.67%)	10 / 37 (27.03%)
occurrences all number	15	17	19	20	22	20
Dermatitis contact
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	1	0	0
Ecchymosis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Eczema
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	1 / 30 (3.33%)	1 / 37 (2.70%)
occurrences all number	0	0	0	1	1	1
Folliculitis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	1	0	0
Onychoclasis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Pruritus
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	2 / 36 (5.56%)	0 / 38 (0.00%)	2 / 30 (6.67%)	0 / 37 (0.00%)
occurrences all number	0	1	2	0	2	0
Rash
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Rash erythematous
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Seborrhoeic dermatitis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Skin burning sensation
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Renal and urinary disorders
Bladder pain
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Leukocyturia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
Proteinuria
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	1	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	2 / 37 (5.41%)
occurrences all number	1	0	1	0	0	2
Axillary mass
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Back pain
subjects affected / exposed	0 / 36 (0.00%)	2 / 30 (6.67%)	2 / 36 (5.56%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	2	2	0	0	0
Bursitis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Foot deformity
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Groin pain
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Joint swelling
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0	0
Myalgia
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	2 / 36 (5.56%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	1	2	0	0	2
Osteoarthritis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Pain in extremity
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Infections and infestations
Bronchiolitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Bronchitis
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	2 / 37 (5.41%)
occurrences all number	1	0	1	0	0	2
Bronchitis viral
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
Conjunctivitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	3 / 36 (8.33%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	3	1	0	0
Cystitis
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Ear infection
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	2 / 30 (6.67%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	2	0
Erysipelas
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Eyelid infection
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Folliculitis
subjects affected / exposed	2 / 36 (5.56%)	0 / 30 (0.00%)	3 / 36 (8.33%)	3 / 38 (7.89%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	2	0	4	4	1	0
Furuncle
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	1	0	0
Gastroenteritis
subjects affected / exposed	1 / 36 (2.78%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	1 / 30 (3.33%)	1 / 37 (2.70%)
occurrences all number	1	1	0	1	1	1
Herpes simplex
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	1	0	0
Hordeolum
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Impetigo
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	2	0	0	0	0	1
Influenza
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	3	1
Laryngitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Mastitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Nasopharyngitis
subjects affected / exposed	6 / 36 (16.67%)	4 / 30 (13.33%)	6 / 36 (16.67%)	5 / 38 (13.16%)	1 / 30 (3.33%)	7 / 37 (18.92%)
occurrences all number	6	4	8	7	1	9
Onychomycosis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Oral herpes
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	1	0	6
Otitis media
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0
Pharyngitis
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	3 / 36 (8.33%)	0 / 38 (0.00%)	1 / 30 (3.33%)	1 / 37 (2.70%)
occurrences all number	1	0	3	0	1	1
Pulpitis dental
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Respiratory tract infection
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0
Rhinitis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	2	0	0
Sinusitis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 30 (3.33%)	3 / 37 (8.11%)
occurrences all number	0	2	0	0	1	3
Skin bacterial infection
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	1	1	0	1
Soft tissue infection
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Staphylococcal infection
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0
Superinfection
subjects affected / exposed	0 / 36 (0.00%)	2 / 30 (6.67%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	2	0	0	0	0
Superinfection bacterial
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Tonsillitis
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	0	0	0
Tracheitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Upper respiratory tract infection
subjects affected / exposed	3 / 36 (8.33%)	3 / 30 (10.00%)	2 / 36 (5.56%)	1 / 38 (2.63%)	1 / 30 (3.33%)	3 / 37 (8.11%)
occurrences all number	4	3	4	2	2	4
Urinary tract infection
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	2 / 37 (5.41%)
occurrences all number	1	0	0	2	0	2
Vaginal infection
subjects affected / exposed	0 / 36 (0.00%)	1 / 30 (3.33%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0
Metabolism and nutrition disorders
Glucose tolerance impaired
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0
Hyperkalaemia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	1 / 30 (3.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	1	0
Hypertriglyceridaemia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	3 / 36 (8.33%)	1 / 38 (2.63%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	4	1	0	1
Hyperuricaemia
subjects affected / exposed	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	1
Hypoalbuminaemia
subjects affected / exposed	1 / 36 (2.78%)	0 / 30 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 30 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

05 Oct 2018

The changes included: -Updates related to sample size: increased from 180 to 240 subjects in order to increase the precision for the planned population based pharmacokinetic/pharmacodynamic (PK/PD) model used for Phase 3 dose selection. − Update to clarify that subjects who experienced any episode or recurrence of Herpes Zoster infection within 1 year before the screening visit must be excluded (Exclusion Criterion 5). − Deletion of Exclusion Criterion 6, related to tuberculosis testing by Quantiferon TB Gold test, as the exclusion of a history of tuberculosis is in general covered by Exclusion Criterion 4. − Several simplification and clarification in the statistical section as well as some adjustments for consistency with other studies. − Definition of AESIs was updated to indicate that AESI only occur after IMP administration. − Update to add wording related to the new General Data Protection Regulation, which became effective on 25-May-2018.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
28 Oct 2019	On 28-Oct-2019, it was announced that the further development of MOR106 in the indication of moderate to severe AD would not be continuing. This was based on a futility analysis of efficacy data of the interim analysis of the current study. There were no concerns related to safety and tolerability after administration of MOR106. Based on this assessment it was decided, with immediate effect, to stop treatment of participants in all ongoing studies with MOR106. As a consequence of study treatment termination, participants who were in treatment were requested to stop treatment immediately, complete the early treatment discontinuation visit and then start with the 16-week follow-up period.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Participant numbers decreased due to early treatment termination for primary and secondary efficacy endpoints. High placebo values as well as the low participant number at later timepoints should be taken into account when interpreting the result.

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Clinical trials

Clinical Trial Results:
A Phase II, randomized, double-blind, placebo-controlled repeated-dose study to evaluate the efficacy, safety, tolerability, and PK/PD of intravenously administered MOR106 in adult subjects with moderate to severe atopic dermatitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change From Baseline in EASI score At Day 85

Primary: Percent Change From Baseline in EASI score At Day 85

Secondary: Percentage of Subjects who Achieved >=50% Overall improvement in EASI Score From Baseline

Secondary: Percentage of Subjects who Achieved >=50% Overall improvement in EASI Score From Baseline

Secondary: Percentage of Subjects who Achieved an Investigators' Global Assessment (IGA) score of 0 or 1

Secondary: Percentage of Subjects who Achieved an Investigators' Global Assessment (IGA) score of 0 or 1

Secondary: Percent Change From Baseline in SCORAD Score

Secondary: Percent Change From Baseline in SCORAD Score

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)

Secondary: Number of Subjects with Anti-drug Antibodies (ADAs)

Secondary: Number of Subjects with Anti-drug Antibodies (ADAs)

Secondary: Area Under the Concentration-time Curve From Zero to Infinity (AUC0-inf) for MOR106

Secondary: Area Under the Concentration-time Curve From Zero to Infinity (AUC0-inf) for MOR106

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A Phase II, randomized, double-blind, placebo-controlled repeated-dose study to evaluate the efficacy, safety, tolerability, and PK/PD of intravenously administered MOR106 in adult subjects with moderate to severe atopic dermatitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change From Baseline in EASI score At Day 85

Primary: Percent Change From Baseline in EASI score At Day 85

Secondary: Percentage of Subjects who Achieved >=50% Overall improvement in EASI Score From Baseline

Secondary: Percentage of Subjects who Achieved >=50% Overall improvement in EASI Score From Baseline

Secondary: Percentage of Subjects who Achieved an Investigators' Global Assessment (IGA) score of 0 or 1

Secondary: Percentage of Subjects who Achieved an Investigators' Global Assessment (IGA) score of 0 or 1

Secondary: Percent Change From Baseline in SCORAD Score

Secondary: Percent Change From Baseline in SCORAD Score

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)

Secondary: Number of Subjects with Anti-drug Antibodies (ADAs)

Secondary: Number of Subjects with Anti-drug Antibodies (ADAs)

Secondary: Area Under the Concentration-time Curve From Zero to Infinity (AUC0-inf) for MOR106

Secondary: Area Under the Concentration-time Curve From Zero to Infinity (AUC0-inf) for MOR106

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase II, randomized, double-blind, placebo-controlled repeated-dose study to evaluate the efficacy, safety, tolerability, and PK/PD of intravenously administered MOR106 in adult subjects with moderate to severe atopic dermatitis