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Clinical Trial Results:
A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA

Summary
EudraCT number	2017-001677-16
Trial protocol	DE FR
Global end of trial date	17 Mar 2020

Results information
Results version number	v1(current)
This version publication date	28 Mar 2021
First version publication date	28 Mar 2021
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

RD.03.SPR.104003

ISRCTN number

US NCT number

NCT03292406

WHO universal trial number (UTN)

Sponsor organisation name

Galderma R&D SNC

Sponsor organisation address

Les Templiers, 2400 route des Colles, Biot, France, 06410

Public contact

CTA Coordinator, Galderma R&D SNC, +33 493-95-70-85, cta.coordinator@galderma.com

Scientific contact

CTA Coordinator, Galderma R&D SNC, +33 493-95-70-85, cta.coordinator@galderma.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

17 Mar 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Mar 2020

Was the trial ended prematurely?

Main objective of the trial

To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in the treatment of CTCL (stage IA, IB, or IIA) versus placebo.

Protection of trial subjects

This clinical trial was conducted in accordance with the protocol, the Helsinki declaration (1964) and subsequent amendments, and the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and in compliance with applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Dec 2017

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

1 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 48

Country: Number of subjects enrolled

France: 9

Country: Number of subjects enrolled

Germany: 29

Worldwide total number of subjects

EEA total number of subjects

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)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This study was conducted at 3 countries (France, Germany, USA) between 19 Dec 2017 to 17 Mar 2020. A total of 86 subjects were randomized to 1 of the 3 treatment groups (placebo gel or CD11301 gel 0.03% or 0.06%) in a 1:1:1 ratio.

Screening details

This study consisted of 2 cycles: Cycle 1 and Cycle 2. Each treatment cycle consisted of 8 weeks on treatment followed by 4 weeks without treatment. Cycle 1: drug product was applied on up to 5 percent (%) body surface area (BSA) and 10% BSA in cycle 2.

Period 1 title

Overall Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

CD11301 Gel 0.06%

Arm description

Subjects applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.

Arm type

Experimental

Investigational medicinal product name

CD11301 gel

Investigational medicinal product code

Other name

Pharmaceutical forms

Gel

Routes of administration

Topical use

Dosage and administration details

Subjects applied (either 0.03% or 0.06%) of CD11301 gel topically for 24 weeks.

CD11301 Gel 0.03%

Arm description

Subjects applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.

Arm type

Experimental

Investigational medicinal product name

CD11301 gel

Investigational medicinal product code

Other name

Pharmaceutical forms

Gel

Routes of administration

Topical use

Dosage and administration details

Subjects applied (either 0.03% or 0.06%) of CD11301 gel topically for 24 weeks.

Placebo

Arm description

Subjects applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Gel

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo gel during cycle one for 24 weeks.

Investigational medicinal product name

CD11301 gel

Investigational medicinal product code

Other name

Pharmaceutical forms

Gel

Routes of administration

Topical use

Dosage and administration details

Subjects applied (0.03% and 0.06%) of CD11301 gel topically for 24 weeks.

Number of subjects in period 1	CD11301 Gel 0.06%	CD11301 Gel 0.03%	Placebo
Started	30	28	28
Subjects Treated	30	28	27
Completed	17	15	15
Not completed	13	13	13
Consent withdrawn by subject	-	7	2
Adverse event, non-fatal	7	1	4
Progressive Disease	6	3	4
Unspecified	-	1	2
Protocol deviation	-	1	1

Baseline characteristics

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Reporting group title

CD11301 Gel 0.06%

Reporting group description

Subjects applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.

Reporting group title

CD11301 Gel 0.03%

Reporting group description

Subjects applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.

Reporting group title

Placebo

Reporting group description

Subjects applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.

Reporting group values	CD11301 Gel 0.06%	CD11301 Gel 0.03%	Placebo	Total
Number of subjects	30	28	28	86
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	15	17	13	45
From 65-84 years	15	11	15	41
85 years and over	0	0	0	0
Gender categorical
Units: Subjects
Female	8	8	12	28
Male	22	20	16	58

End points

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Reporting group title

CD11301 Gel 0.06%

Reporting group description

Subjects applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.

Reporting group title

CD11301 Gel 0.03%

Reporting group description

Subjects applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.

Reporting group title

Placebo

Reporting group description

Subjects applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.

Primary: Number of Subjects Reported Overall Response (OR) (Complete and Partial [CR or PR]) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12

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End point title

Number of Subjects Reported Overall Response (OR) (Complete and Partial [CR or PR]) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12

End point description

OR is defined as the number of subjects that achieved a CR or PR as assessed by mCAILS. mCAILS total was derived from components collected on the case report form (CRF).Target treated lesions(1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8=very severe), scaling(0-8,where 0=no evidence and 8=very severe), plaque elevation (0-3,where 0=no evidence and 3=marked elevation), and size (scale=0-18, where 0=no measurable area and 18=size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion.Final mCAILS assessment score was the sum of these subtotals.Total summation Score: 0-50 where higher score indicated higher severity. CR is defined as a 100% decrease from baseline i.e. score of ‘0’ on the mCAILS scale. PR is defined as at least a 50%, but less than 100%, decrease from baseline. ITT Population included all randomized subjects. Here, overall number of subjects analyzed signifies subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Week 12

End point values	CD11301 Gel 0.06%	CD11301 Gel 0.03%	Placebo
Number of subjects analysed	4	7	1
Units: Subjects
Complete Response	0	2	0
Partial Response	4	5	1

Placebo versus CD11301 0.06%

Statistical analysis description

Difference in Response Rate from Placebo (SE)

Comparison groups

CD11301 Gel 0.06% v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3446

Method

Cochran-Mantel-Haenszel

Parameter type

Strata-adjusted Difference in Response R

Point estimate

10.4

Confidence interval

level

95%

sides

2-sided

lower limit

-8.2

upper limit

26.6

Placebo versus CD11301 0.03%

Comparison groups

CD11301 Gel 0.03% v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.1088

Method

Cochran-Mantel-Haenszel

Parameter type

Strata-adjusted Difference in Response R

Point estimate

Confidence interval

level

97.5%

sides

2-sided

lower limit

-4.5

upper limit

41.1

Notes
[1] - Strata-adjusted Difference in Response Rate from Placebo was analyzed and reported.

Secondary: Number of Subjects Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity- Weighted Assessment Tool (mSWAT) Score at Week 12

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End point title

Number of Subjects Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity- Weighted Assessment Tool (mSWAT) Score at Week 12

End point description

OR is defined as the number of subjects that achieved a CR or PR as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the subject= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). CR is defined as a 100% decrease from baseline. PR is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor). ITT Population included all randomized subjects. Here, overall number of subjects analyzed signifies number of subjects who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 12

End point values	CD11301 Gel 0.06%	CD11301 Gel 0.03%	Placebo
Number of subjects analysed	6	4	2
Units: subjects
Complete Response	0	0	0
Partial Response	6	4	2

No statistical analyses for this end point

Secondary: Time to Subject's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score

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End point title

Time to Subject's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score

End point description

Time to OR (CR or PR) is the number of days from the start of drug application to the first documentation of OR assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. ITT Population included all randomized subjects. Here, overall number of subjects analyzed signifies subjects who were evaluable for this endpoint. Here 99999 indicates Missing quartiles and CIs were non-estimable due to a lack of events.

End point type

Secondary

End point timeframe

Up to Week 36

End point values	CD11301 Gel 0.06%	CD11301 Gel 0.03%	Placebo
Number of subjects analysed	16	12	1
Units: Days
number (confidence interval 95%)
25th (95% CI)	169 (84 to 169.0)	85 (83 to 174)	99999 (85.0 to 99999)
50th (95% CI)	197 (169 to 257)	99999 (99999 to 99999)	99999 (99999 to 99999)
75th (95% CI)	257 (197 to 257)	99999 (99999 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score

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End point title

Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score

End point description

The duration of OR (CR or PR) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) – (date of response) + 1. mCAILS assessment total was derived from components collected on CRF. Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8=very severe), scaling (0-8, where 0=no evidence and 8=very severe), plaque elevation (0-3, where 0=no evidence and 3=marked elevation), and size (scale=0-18, where 0=no measurable area and 18= size of lesion >300 cm^2). These 4 ratings were summed to create subtotals, 1 per lesion. Final mCAILS assessment score was sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. ITT Population included all randomized subjects. Here, overall number of subjects analyzed signifies subjects who were evaluable for this endpoint. Here 99999 indicates missing quartiles and CIs were non-estimable due to lack of events.

End point type

Secondary

End point timeframe

Up to Week 36

End point values	CD11301 Gel 0.06%	CD11301 Gel 0.03%	Placebo
Number of subjects analysed	12	10	1
Units: Days
number (confidence interval 95%)
25th (95% CI)	133 (29.0 to 141.0)	99999 (38.0 to 99999)	99999 (99999 to 99999)
50th (95% CI)	141 (133.0 to 99999)	99999 (38.0 to 99999)	99999 (99999 to 99999)
75th (95% CI)	99999 (133.0 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Time to Progressive Disease Using mSWAT

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End point title

Time to Progressive Disease Using mSWAT

End point description

Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response). ITT Population included all randomized subjects. Here, overall number of subjects analyzed signifies number of subjects who were evaluable for this endpoint. Here 99999 and -99999 indicates missing quartiles and CIs were non-estimable due to a lack of events.

End point type

Secondary

End point timeframe

Up to Week 36

End point values	CD11301 Gel 0.06%	CD11301 Gel 0.03%	Placebo
Number of subjects analysed	26	21	24
Units: Days
number (confidence interval 95%)
25th (95% CI)	99999 (170 to 99999)	191 (85 to 99999)	93 (85 to 93)
50th (95% CI)	99999 (99999 to 99999)	99999 (99999 to 99999)	93 (-99999 to 99999)
75th (95% CI)	99999 (99999 to 99999)	99999 (99999 to 99999)	93 (-99999 to 99999)

No statistical analyses for this end point

Secondary: Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36

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End point title

Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36

End point description

Subjects answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life. ITT Population included all randomized subjects. Here, overall number of subjects analyzed signifies subjects who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 12, 24 and Follow up (Week 36)

End point values	CD11301 Gel 0.06%	CD11301 Gel 0.03%	Placebo
Number of subjects analysed	29	28	27
Units: score on scale
arithmetic mean (standard deviation)
Week 12	1.93 ( 12.408 )	-0.27 ( 8.583 )	-1.58 ( 13.243 )
Week 24 (n=23, 26, 24)	-2.16 ( 11.651 )	-3.36 ( 9.816 )	0.58 ( 16.059 )
Week 36 (n= 22, 19, 20)	-3.30 ( 14.838 )	-3.22 ( 8.340 )	-0.34 ( 14.081 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From start of the study drug administration up to end of the study (Week 72)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

Group 1

Reporting group description

Subjects applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for 24 weeks.

Reporting group title

Group 2

Reporting group description

Subjects applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for 24 weeks.

Reporting group title

Group 3

Reporting group description

Subjects applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.

Serious adverse events	Group 1	Group 2	Group 3
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 30 (6.67%)	2 / 28 (7.14%)	1 / 27 (3.70%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
subjects affected / exposed	0 / 30 (0.00%)	0 / 28 (0.00%)	1 / 27 (3.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Metastases to bone
subjects affected / exposed	0 / 30 (0.00%)	0 / 28 (0.00%)	1 / 27 (3.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Metastases to central nervous system
subjects affected / exposed	0 / 30 (0.00%)	0 / 28 (0.00%)	1 / 27 (3.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Metastases to muscle
subjects affected / exposed	0 / 30 (0.00%)	0 / 28 (0.00%)	1 / 27 (3.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Papillary cystadenoma lymphomatosum
subjects affected / exposed	0 / 30 (0.00%)	1 / 28 (3.57%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Sinus bradycardia
subjects affected / exposed	0 / 30 (0.00%)	1 / 28 (3.57%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Sciatica
subjects affected / exposed	1 / 30 (3.33%)	0 / 28 (0.00%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	1 / 30 (3.33%)	0 / 28 (0.00%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Group 1	Group 2	Group 3
Total subjects affected by non serious adverse events
subjects affected / exposed	30 / 30 (100.00%)	28 / 28 (100.00%)	27 / 27 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
subjects affected / exposed	3 / 30 (10.00%)	4 / 28 (14.29%)	5 / 27 (18.52%)
occurrences all number	3	4	5
Vascular disorders
Hypertension
subjects affected / exposed	3 / 30 (10.00%)	2 / 28 (7.14%)	1 / 27 (3.70%)
occurrences all number	3	2	1
General disorders and administration site conditions
Application site dermatitis
subjects affected / exposed	4 / 30 (13.33%)	3 / 28 (10.71%)	1 / 27 (3.70%)
occurrences all number	4	3	1
Application site eczema
subjects affected / exposed	0 / 30 (0.00%)	0 / 28 (0.00%)	2 / 27 (7.41%)
occurrences all number	0	0	2
Application site erosion
subjects affected / exposed	9 / 30 (30.00%)	3 / 28 (10.71%)	2 / 27 (7.41%)
occurrences all number	9	3	2
Application site erythema
subjects affected / exposed	7 / 30 (23.33%)	5 / 28 (17.86%)	2 / 27 (7.41%)
occurrences all number	7	5	2
Application site inflammation
subjects affected / exposed	0 / 30 (0.00%)	6 / 28 (21.43%)	1 / 27 (3.70%)
occurrences all number	0	6	1
Application site irritation
subjects affected / exposed	1 / 30 (3.33%)	5 / 28 (17.86%)	1 / 27 (3.70%)
occurrences all number	1	5	1
Application site pain
subjects affected / exposed	6 / 30 (20.00%)	3 / 28 (10.71%)	2 / 27 (7.41%)
occurrences all number	6	3	2
Application site pruritus
subjects affected / exposed	4 / 30 (13.33%)	8 / 28 (28.57%)	4 / 27 (14.81%)
occurrences all number	4	8	4
Application site rash
subjects affected / exposed	2 / 30 (6.67%)	1 / 28 (3.57%)	0 / 27 (0.00%)
occurrences all number	2	1	0
Application site ulcer
subjects affected / exposed	8 / 30 (26.67%)	8 / 28 (28.57%)	2 / 27 (7.41%)
occurrences all number	8	8	2
Asthenia
subjects affected / exposed	1 / 30 (3.33%)	2 / 28 (7.14%)	0 / 27 (0.00%)
occurrences all number	1	2	0
Chills
subjects affected / exposed	1 / 30 (3.33%)	0 / 28 (0.00%)	3 / 27 (11.11%)
occurrences all number	1	0	3
Fatigue
subjects affected / exposed	5 / 30 (16.67%)	5 / 28 (17.86%)	2 / 27 (7.41%)
occurrences all number	5	5	2
Influenza like illness
subjects affected / exposed	6 / 30 (20.00%)	3 / 28 (10.71%)	2 / 27 (7.41%)
occurrences all number	6	3	2
Pyrexia
subjects affected / exposed	3 / 30 (10.00%)	2 / 28 (7.14%)	0 / 27 (0.00%)
occurrences all number	3	2	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	2 / 30 (6.67%)	2 / 28 (7.14%)	0 / 27 (0.00%)
occurrences all number	2	2	0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 30 (3.33%)	0 / 28 (0.00%)	2 / 27 (7.41%)
occurrences all number	1	0	2
Investigations
Alanine aminotransferase increased
subjects affected / exposed	4 / 30 (13.33%)	1 / 28 (3.57%)	1 / 27 (3.70%)
occurrences all number	4	1	1
Aspartate aminotransferase increased
subjects affected / exposed	2 / 30 (6.67%)	1 / 28 (3.57%)	1 / 27 (3.70%)
occurrences all number	2	1	1
Gamma-glutamyltransferase increased
subjects affected / exposed	2 / 30 (6.67%)	1 / 28 (3.57%)	0 / 27 (0.00%)
occurrences all number	2	1	0
Urine leukocyte esterase positive
subjects affected / exposed	1 / 30 (3.33%)	0 / 28 (0.00%)	2 / 27 (7.41%)
occurrences all number	1	0	2
White blood cell count decreased
subjects affected / exposed	2 / 30 (6.67%)	0 / 28 (0.00%)	1 / 27 (3.70%)
occurrences all number	2	0	1
Injury, poisoning and procedural complications
Thermal burn
subjects affected / exposed	2 / 30 (6.67%)	0 / 28 (0.00%)	0 / 27 (0.00%)
occurrences all number	2	0	0
Cardiac disorders
Sinus bradycardia
subjects affected / exposed	0 / 30 (0.00%)	1 / 28 (3.57%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Atrioventricular block first degree
subjects affected / exposed	0 / 30 (0.00%)	1 / 28 (3.57%)	2 / 27 (7.41%)
occurrences all number	0	1	2
Bundle branch block left
subjects affected / exposed	2 / 30 (6.67%)	0 / 28 (0.00%)	0 / 27 (0.00%)
occurrences all number	2	0	0
Nervous system disorders
Headache
subjects affected / exposed	7 / 30 (23.33%)	5 / 28 (17.86%)	1 / 27 (3.70%)
occurrences all number	7	5	1
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	4 / 30 (13.33%)	1 / 28 (3.57%)	0 / 27 (0.00%)
occurrences all number	4	1	0
Nausea
subjects affected / exposed	4 / 30 (13.33%)	2 / 28 (7.14%)	2 / 27 (7.41%)
occurrences all number	4	2	2
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	0 / 30 (0.00%)	2 / 28 (7.14%)	0 / 27 (0.00%)
occurrences all number	0	2	0
Dry skin
subjects affected / exposed	1 / 30 (3.33%)	0 / 28 (0.00%)	2 / 27 (7.41%)
occurrences all number	1	0	2
Erythema
subjects affected / exposed	1 / 30 (3.33%)	1 / 28 (3.57%)	2 / 27 (7.41%)
occurrences all number	1	1	2
Night sweats
subjects affected / exposed	0 / 30 (0.00%)	2 / 28 (7.14%)	0 / 27 (0.00%)
occurrences all number	0	2	0
Papule
subjects affected / exposed	1 / 30 (3.33%)	2 / 28 (7.14%)	0 / 27 (0.00%)
occurrences all number	1	2	0
Pruritus
subjects affected / exposed	2 / 30 (6.67%)	3 / 28 (10.71%)	5 / 27 (18.52%)
occurrences all number	2	3	5
Rash
subjects affected / exposed	0 / 30 (0.00%)	2 / 28 (7.14%)	0 / 27 (0.00%)
occurrences all number	0	2	0
Rash maculo-papular
subjects affected / exposed	0 / 30 (0.00%)	0 / 28 (0.00%)	2 / 27 (7.41%)
occurrences all number	0	0	2
Skin erosion
subjects affected / exposed	5 / 30 (16.67%)	2 / 28 (7.14%)	1 / 27 (3.70%)
occurrences all number	5	2	1
Skin ulcer
subjects affected / exposed	0 / 30 (0.00%)	2 / 28 (7.14%)	2 / 27 (7.41%)
occurrences all number	0	2	2
Renal and urinary disorders
Haematuria
subjects affected / exposed	1 / 30 (3.33%)	1 / 28 (3.57%)	2 / 27 (7.41%)
occurrences all number	1	1	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 30 (6.67%)	0 / 28 (0.00%)	1 / 27 (3.70%)
occurrences all number	2	0	1
Back pain
subjects affected / exposed	4 / 30 (13.33%)	1 / 28 (3.57%)	1 / 27 (3.70%)
occurrences all number	4	1	1
Myalgia
subjects affected / exposed	2 / 30 (6.67%)	1 / 28 (3.57%)	1 / 27 (3.70%)
occurrences all number	2	1	1
Infections and infestations
Folliculitis
subjects affected / exposed	1 / 30 (3.33%)	3 / 28 (10.71%)	0 / 27 (0.00%)
occurrences all number	1	3	0
Fungal skin infection
subjects affected / exposed	2 / 30 (6.67%)	0 / 28 (0.00%)	0 / 27 (0.00%)
occurrences all number	2	0	0
Hordeolum
subjects affected / exposed	2 / 30 (6.67%)	0 / 28 (0.00%)	0 / 27 (0.00%)
occurrences all number	2	0	0
Upper respiratory tract infection
subjects affected / exposed	3 / 30 (10.00%)	3 / 28 (10.71%)	2 / 27 (7.41%)
occurrences all number	3	3	2
Viral upper respiratory tract infection
subjects affected / exposed	4 / 30 (13.33%)	4 / 28 (14.29%)	0 / 27 (0.00%)
occurrences all number	4	4	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	2 / 30 (6.67%)	1 / 28 (3.57%)	1 / 27 (3.70%)
occurrences all number	2	1	1

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Were there any global substantial amendments to the protocol? Yes

16 Feb 2018

Amendment 1: Updated the CAILS assessment tool to modified CAILS, on the recommendation of industry investigator experts. -Clarified total daily dosage of investigational product throughout the protocol. -Clarified how the dosing amount to be applied on each subject was determined. -Clarified why women of childbearing potential were allowed in the study. -Clarified why women of childbearing potential were allowed in the study. -Added responsibility of the IDMC. -Added recruitment procedures to the protocol. -Allowed subjects to be re-screened once. -Allowed documentation of histological finding of CTCL within last 12 months or to perform a skin biopsy to confirm during the screening visit if one was not available. -Expanded the B0 definition for inclusion criteria #4. - Updated the double-barrier contraception method. - Changed the wording about the systemic pharmacodynamics assessment. -All centers were asked to collect blood samples for immune cell dynamics. -Removed all proteomic biomarker assessments.

16 Apr 2018

Amendment 2: Inclusion criterion was added: BfArM requested that subjects only be permitted to participate in the trial after the German S2K guidelines for cutaneous lymphoma treatment were either contraindicated, insufficiently effective, or poorly tolerated.

25 Mar 2019

Amendment 3: - Amended withdrawal criteria in case of disease progression such that an assessment of progressive disease in subjects with stage IA MF-CTCL at Baseline presenting a -25% increase in skin disease (mSWAT) would not be clinically meaningful if the BSA affected were <10%. - Change of sponsor address and phone number. - Extended the study to follow complete responders of mSWAT at Week 36 up to Week 72 or until relapse. - Clarification of inclusion criterion #4: subjects were required to be B0. - Addendum to the clinical study report to provide time to relapse. - Clarification of pregnancy tests.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results:
A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects Reported Overall Response (OR) (Complete and Partial [CR or PR]) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12

Primary: Number of Subjects Reported Overall Response (OR) (Complete and Partial [CR or PR]) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12

Secondary: Number of Subjects Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity- Weighted Assessment Tool (mSWAT) Score at Week 12

Secondary: Number of Subjects Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity- Weighted Assessment Tool (mSWAT) Score at Week 12

Secondary: Time to Subject's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score

Secondary: Time to Subject's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score

Secondary: Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score

Secondary: Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score

Secondary: Time to Progressive Disease Using mSWAT

Secondary: Time to Progressive Disease Using mSWAT

Secondary: Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36

Secondary: Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
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Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
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Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects Reported Overall Response (OR) (Complete and Partial [CR or PR]) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12

Primary: Number of Subjects Reported Overall Response (OR) (Complete and Partial [CR or PR]) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12

Secondary: Number of Subjects Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity- Weighted Assessment Tool (mSWAT) Score at Week 12

Secondary: Number of Subjects Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity- Weighted Assessment Tool (mSWAT) Score at Week 12

Secondary: Time to Subject's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score

Secondary: Time to Subject's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score

Secondary: Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score

Secondary: Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score

Secondary: Time to Progressive Disease Using mSWAT

Secondary: Time to Progressive Disease Using mSWAT

Secondary: Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36

Secondary: Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA