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Clinical Trial Results:
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1-antihistamine Treatment

Summary
EudraCT number	2020-000952-36
Trial protocol	HU PL BG GR
Global end of trial date	11 Sep 2023

Results information
Results version number	v1(current)
This version publication date	30 Oct 2024
First version publication date	30 Oct 2024
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

CT-P39_3.1

ISRCTN number

US NCT number

NCT04426890

WHO universal trial number (UTN)

Sponsor organisation name

Celltrion, Inc.

Sponsor organisation address

23, Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of, 22014

Public contact

Keum Young Ahn, Celltrion Inc., 82 328504190, KeumYoung.Ahn@celltrion.com

Scientific contact

Keum Young Ahn, Celltrion Inc., 82 328504190, KeumYoung.Ahn@celltrion.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

11 Sep 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

11 Sep 2023

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the equivalence of CT P39 to Xolair at a dose of 300 mg in terms of efficacy in patients with chronic spontaneous urticaria (CSU) as determined by change from baseline in weekly itch severity score (ISS7) at Week 12

Protection of trial subjects

The study was conducted according to the protocol and in compliance with the International Council for Harmonisation (ICH) E6(R2) with the Declaration of Helsinki (World Medical Association, 2013). The Investigator conducted all aspects of this study in accordance with all national, state, and local laws or regulations. An informed consent document approved by each study site’s IEC/IRB was signed by the patient/legal guardian after the Investigator assured that the patient/legal guardian understands the implications of participating in the study. The authorized person obtained the informed consent before the patient entered in the study. Patients aged 12 to 17 years (both inclusive) provided their consent on adolescent assent form and the consent was also taken by their parent/legal guardian. Patients aged ≥ 18 years provided their consent on adult ICF.

Background therapy

All patients continued to concomitantly receive an approved dose of nonsedating H1-antihistamine treatment throughout the study.

Evidence for comparator

Actual start date of recruitment

13 Nov 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 262

Country: Number of subjects enrolled

Bulgaria: 125

Country: Number of subjects enrolled

Greece: 6

Country: Number of subjects enrolled

Hungary: 6

Country: Number of subjects enrolled

Korea, Republic of: 119

Country: Number of subjects enrolled

Ukraine: 101

Worldwide total number of subjects

619

EEA total number of subjects

399

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)

569

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

First patient assigned to treatment date was on 09 December 2020. A total of 783 patients were screened from 64 study centers in 6 countries (Bulgaria, Greece, Hungary, Poland, South Korea, and Ukraine) and 634 patients were enrolled from 62 study centers in this study.

Screening details

Male or female patients with a history of at least 6 months of CSU who had hives and itching for 6 consecutive weeks or more despite current use of H1-antihistamines for this time period were enrolled in the study if they had met all of the inclusion criteria and none of the exclusion criteria.

Number of subjects started

783 ^[1]

Number of subjects completed

619

Reason: Number of subjects

Inclusion/Exclusion criteria not met: 83

Reason: Number of subjects

Consent withdrawn by subject: 42

Reason: Number of subjects

Other: 24

Reason: Number of subjects

GCP noncompliant site: 15

Notes
[1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 783 patients were screened and 634 were enrolled, of which 15 patients were excluded from all analyses due to the site being non-GCP compliant

Period 1 title

Treatment Period 1

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

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

Blinding implementation details

To minimize the risk of unblinding, the study drug was administered by pre-defined unblinded site personnel. The unblinded sponsor and CRO personnel responsible for the randomization or administration of study drugs were pre-defined and were not permitted to conduct any patient assessments. Also, to maintain the study blind with respect to the 2-dose levels (300 mg versus 150 mg), patients who received one (150 mg) injection of study drug, also received additional placebo.

Are arms mutually exclusive

Yes

CT-P39 300 mg

Arm description

CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Arm type

Experimental

Investigational medicinal product name

CT-P39

Investigational medicinal product code

Other name

omalizumab, Omlyclo

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg injected subcutaneously every 4 weeks

Xolair 300 mg

Arm description

Xolair 300 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Arm type

Active comparator

Investigational medicinal product name

Xolair

Investigational medicinal product code

Other name

omalizumab

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg injected subcutaneously every 4 weeks

CT-P39 150 mg

Arm description

CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Arm type

Experimental

Investigational medicinal product name

CT-P39

Investigational medicinal product code

Other name

omalizumab, Omlyclo

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg injected subcutaneously every 4 weeks

Xolair 150 mg

Arm description

Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Arm type

Active comparator

Investigational medicinal product name

Xolair

Investigational medicinal product code

Other name

omalizumab

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg injected subcutaneously every 4 weeks

Number of subjects in period 1	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Started	204	205	107	103
Completed	187	193	101	98
Not completed	17	12	6	5
Patient refusal	1	1	1	-
Consent withdrawn by subject	7	6	4	5
Disease progression	1	1	-	-
Adverse event, non-fatal	3	1	-	-
Other	4	-	-	-
Randomized by mistake	1	-	-	-
Lost to follow-up	-	-	1	-
Protocol deviation	-	3	-	-

Period 2 title

Treatment Period 2

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

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

Blinding implementation details

Are arms mutually exclusive

Yes

CT-P39 300 mg maintenance

Arm description

Received CT-P39 300 mg in TP1 and continued on CT-P39 300 mg in TP2 (Week 12, 16, 20)

Arm type

Experimental

Investigational medicinal product name

CT-P39

Investigational medicinal product code

Other name

omalizumab, Omlyclo

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg injected subcutaneously every 4 weeks

Switched to CT-P39 300 mg

Arm description

Received Xolair 300 mg in TP1 and re-randomized to receive CT-P39 300 mg in TP2 (Week 12, 16, 20)

Arm type

Experimental

Investigational medicinal product name

CT-P39

Investigational medicinal product code

Other name

omalizumab, Omlyclo

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg injected subcutaneously every 4 weeks

Xolair 300 mg maintenance

Arm description

Received Xolair 300 mg in TP1 and re-randomized to continue on Xolair 300 mg in TP2 (Week 12, 16, 20)

Arm type

Active comparator

Investigational medicinal product name

Xolair

Investigational medicinal product code

Other name

omalizumab

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg injected subcutaneously every 4 weeks

CT-P39 Dose increased

Arm description

Received CT-P39 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; CT-P39 300 mg in TP2 (Week 12, 16, 20)

Arm type

Experimental

Investigational medicinal product name

CT-P39

Investigational medicinal product code

Other name

omalizumab, Omlyclo

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg injected subcutaneously every 4 weeks

Xolair Dose increased

Arm description

Received Xolair 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; Xolair 300 mg in TP2 (Week 12, 16, 20)

Arm type

Active comparator

Investigational medicinal product name

Xolair

Investigational medicinal product code

Other name

omalizumab

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg injected subcutaneously every 4 weeks

Number of subjects in period 2	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Started	187	96	97	101	98
Completed	181	94	94	99	94
Not completed	6	2	3	2	4
Consent withdrawn by subject	3	1	-	-	2
Physician decision	-	-	1	1	-
Disease progression	1	-	-	-	-
Adverse event, non-fatal	1	-	-	-	-
Other	1	1	-	-	1
Randomized by mistake	-	-	1	-	-
Lost to follow-up	-	-	1	1	1

Period 3 title

Follow up period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

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

Blinding implementation details

No treatment was administered during the Follow up Period

Are arms mutually exclusive

Yes

Follow up Period: CT-P39 300 mg Maintenance

Arm description

Patients who were in the CT-P39 300 mg arm in TP1 and continued on CT-P39 300 mg during TP2 (Weeks 12, 16, 20) and entered the Follow up Period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Follow up Period: Switched to CT-P39 300 mg

Arm description

Received Xolair 300 mg in TP1 and re-randomized to CT-P39 300 mg in TP2 (Weeks 12, 16, 20) and entered the Follow up Period

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Follow up Period: Xolair 300 mg maintenance

Arm description

Received Xolair 300 mg in TP1 and re-randomized to continue on Xolair 300 mg in TP2 (Weeks 12, 16, 20) and entered the Follow up Period

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Follow up Period: CT-P39 Dose increased

Arm description

Received CT-P39 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; CT-P39 300 mg in TP2 (Week 12, 16, 20) and entered the Follow up Period

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Follow up Period: Xolair Dose increased

Arm description

Received Xolair 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; Xolair 300 mg in TP2 (Week 12, 16, 20) and entered the Follow up Period

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 3 ^[2]	Follow up Period: CT-P39 300 mg Maintenance	Follow up Period: Switched to CT-P39 300 mg	Follow up Period: Xolair 300 mg maintenance	Follow up Period: CT-P39 Dose increased	Follow up Period: Xolair Dose increased
Started	180	90	92	97	90
Completed	170	84	86	90	83
Not completed	10	6	6	7	7
Consent withdrawn by subject	4	-	4	2	4
Physician decision	2	1	1	-	-
Other	4	5	-	4	3
Lost to follow-up	-	-	1	1	-

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Some patients were withdrawn from treatment but continued with the study assessments (they were withdrawn from treatment but not terminated from the study)

Baseline characteristics

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Reporting group title

CT-P39 300 mg

Reporting group description

CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

Xolair 300 mg

Reporting group description

Xolair 300 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

CT-P39 150 mg

Reporting group description

CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

Xolair 150 mg

Reporting group description

Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg	Total
Number of subjects	204	205	107	103	619
Age categorical
Units: Subjects
In utero					0
Preterm newborn infants (gestational age < 37 wks)					0
Newborns (0-27 days)					0
Infants and toddlers (28 days-23 months)					0
Children (2-11 years)					0
Adolescents (12-17 years)					0
Adults (18-64 years)					0
From 65-84 years					0
85 years and over					0
Age continuous
Units: years
arithmetic mean (standard deviation)	43.2 ( 13.3 )	42.9 ( 13.7 )	42.9 ( 15.0 )	41.5 ( 13.8 )	-
Gender categorical
Units: Subjects
Female	133	131	67	72	403
Male	71	74	40	31	216
Baseline ISS7
Units: Subjects
< 13 points	36	42	20	17	115
>= 13 points	168	163	87	86	504
Weight on Day 1
Units: Subjects
< 80 kg	123	125	65	65	378
>= 80 kg	81	80	42	38	241
Country
Units: Subjects
Bulgaria	40	42	23	20	125
Greece	3	1	1	1	6
Hungary	1	2	2	1	6
Korea	38	40	21	20	119
Poland	87	87	43	45	262
Ukraine	35	33	17	16	101

End points

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Reporting group title

CT-P39 300 mg

Reporting group description

CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

Xolair 300 mg

Reporting group description

Xolair 300 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

CT-P39 150 mg

Reporting group description

CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

Xolair 150 mg

Reporting group description

Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

CT-P39 300 mg maintenance

Reporting group description

Received CT-P39 300 mg in TP1 and continued on CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Switched to CT-P39 300 mg

Reporting group description

Received Xolair 300 mg in TP1 and re-randomized to receive CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Xolair 300 mg maintenance

Reporting group description

Received Xolair 300 mg in TP1 and re-randomized to continue on Xolair 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

CT-P39 Dose increased

Reporting group description

Received CT-P39 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Xolair Dose increased

Reporting group description

Received Xolair 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; Xolair 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Follow up Period: CT-P39 300 mg Maintenance

Reporting group description

Patients who were in the CT-P39 300 mg arm in TP1 and continued on CT-P39 300 mg during TP2 (Weeks 12, 16, 20) and entered the Follow up Period.

Reporting group title

Follow up Period: Switched to CT-P39 300 mg

Reporting group description

Received Xolair 300 mg in TP1 and re-randomized to CT-P39 300 mg in TP2 (Weeks 12, 16, 20) and entered the Follow up Period

Reporting group title

Follow up Period: Xolair 300 mg maintenance

Reporting group description

Received Xolair 300 mg in TP1 and re-randomized to continue on Xolair 300 mg in TP2 (Weeks 12, 16, 20) and entered the Follow up Period

Reporting group title

Follow up Period: CT-P39 Dose increased

Reporting group description

Received CT-P39 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; CT-P39 300 mg in TP2 (Week 12, 16, 20) and entered the Follow up Period

Reporting group title

Follow up Period: Xolair Dose increased

Reporting group description

Received Xolair 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; Xolair 300 mg in TP2 (Week 12, 16, 20) and entered the Follow up Period

Primary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 12

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End point title

Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 12 ^[1]

End point description

The primary efficacy evaluations is to compare mean change from baseline in ISS7 of 300 mg of CT-P39 and 300 mg of Xolair at Week 12, calculated as ISS7 at Week 12 minus the baseline ISS7. The statistical analysis of mean change from baseline in ISS7 at Week 12 between CT-P39 300 mg arm and Xolair 300 mg arm using analysis of covariate (ANCOVA) was conducted. The ANCOVA model included the treatment group as a fixed effect and baseline ISS7, body weight on Day 1 and country as covariates.

End point type

Primary

End point timeframe

Week 12

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: Only the CT-P39 300 mg and Xolair 300 mg arms in Treatment Period 1 were included in the primary efficacy endpoint.

End point values	CT-P39 300 mg	Xolair 300 mg
Number of subjects analysed	186	192
Units: score
least squares mean (standard error)	-9.21 ( 0.796 )	-9.98 ( 0.798 )

Primary efficacy: Estimate of treatment difference

Statistical analysis description

The primary efficacy evaluation was comparison of mean change from baseline in ISS7 of 300 mg of CT-P39 (Arm 1) and 300 mg of Xolair (Arm 2) at Week 12, calculated as ISS7 at Week 12 minus the baseline ISS7. The analysis was conducted by analysis of covariance (ANCOVA). The ANCOVA model included the treatment group as a fixed effect and baseline ISS7, body weight on Day 1 and country as covariates.

Comparison groups

CT-P39 300 mg v Xolair 300 mg

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

equivalence ^[2]

Method

ANCOVA

Parameter type

Treatment difference

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-0.37

upper limit

1.9

Notes
[2] - For the demonstration of efficacy, point estimate and 95% CI for the difference in the mean change from baseline in ISS7 at Week 12 between CT-P39 (300 mg) and Xolair (300 mg) will be computed. Therapeutic equivalence will be concluded if the 95% CI for the treatment difference is entirely within an equivalence margin of [-2.0, 2.0]

Secondary: Relative Potency of CT-P39 compared with Xolair

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End point title

Relative Potency of CT-P39 compared with Xolair

End point description

The relative potency of CT-P39 to Xolair was defined as the ratio of equally effective dose of CT-P39 relative to that of Xolair. The therapeutic response was estimated by the change from baseline in ISS7 at Week 12. Since the 2 treatments were compared at the same 2-dose levels (300 mg and 150 mg), a 4-point assay was to be used to calculate the relative potency and its CI. Log dose-therapeutic response curves for each treatment group was to be estimated by linear regression. The change from baseline in ISS7 at Week 12 and dose in the log scale were to be considered as a response variable and independent variable respectively. The baseline ISS7, body weight and country were to be included in a model as covariates. The log relative potency was estimated as the ratio between the estimate of the overall product effect and the estimate of the common slope of log dose. The overall product effect was defined as the difference in response between treatment groups (y-intercepts difference).

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	203 ^[3]	205 ^[4]	107 ^[5]	103 ^[6]
Units: Ratio
number (not applicable)	0	0	0	0

Notes
[3] - Relative potency was not calculated due to assumption of parallel-line assay not being met.
[4] - Relative potency was not calculated due to assumption of parallel-line assay not being met.
[5] - Relative potency was not calculated due to assumption of parallel-line assay not being met.
[6] - Relative potency was not calculated due to assumption of parallel-line assay not being met.

No statistical analyses for this end point

Secondary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 12

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End point title

Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 12

End point description

The change from baseline in ISS7 at Week 12 was calculated as ISS7 at Week 12 minus the baseline ISS7. ISS7 can range from 0 to 21.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	186	192	101	94
Units: Score
arithmetic mean (standard deviation)	-9.31 ( 6.20 )	-9.99 ( 6.18 )	-9.56 ( 5.87 )	-8.73 ( 6.65 )

No statistical analyses for this end point

Secondary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 24

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End point title

Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 24

End point description

The change from baseline in ISS7 at Week 24 was calculated as ISS7 at Week 24 minus the baseline ISS7. ISS7 can range from 0 to 21.

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	170	88	82	90	86
Units: Score
arithmetic mean (standard deviation)	-11.22 ( 6.21 )	-12.24 ( 5.69 )	-11.19 ( 5.88 )	-11.76 ( 5.61 )	-10.70 ( 6.17 )

No statistical analyses for this end point

Secondary: Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12

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End point title

Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12

End point description

Number of patients who achieved MID response at Week 12 were presented. MID response is a change from baseline in ISS7 of ≤ -5. If a patient had missing weekly scores for the given week the patient was classified as a non-responder.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	203 ^[7]	205 ^[8]	107 ^[9]	103 ^[10]
Units: Responder	141	152	78	65

Notes
[7] - Percent MID responders = 69.5%
[8] - Percent MID responders = 74.1%
[9] - Percent MID responders = 72.9%
[10] - Percent MID responders = 63.1%

No statistical analyses for this end point

Secondary: Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 24

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End point title

Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 24

End point description

Patients who achieved MID response at Week 24 were presented. MID response is a change from baseline in ISS7 of ≤ -5. If a patient had missing weekly scores for the given week the patient was classified as a non-responder.

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	187 ^[11]	96 ^[12]	96 ^[13]	101 ^[14]	98 ^[15]
Units: Patients	146	78	71	76	72

Notes
[11] - Percent MID responders = 78.1%
[12] - Percent MID responders = 81.3%
[13] - Percent MID responders = 74.0%
[14] - Percent MID responders = 75.2%
[15] - Percent MID responders = 73.5%

No statistical analyses for this end point

Secondary: Change from Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

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End point title

Change from Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

End point description

The change from baseline in UAS7 at Week 12 was calculated as UAS7 at Week 12 minus the baseline UAS7. UAS7 can range from 0 to 42.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	186	192	101	94
Units: Score
arithmetic mean (standard deviation)	-19.27 ( 12.53 )	-20.54 ( 12.69 )	-19.84 ( 12.02 )	-18.21 ( 13.06 )

No statistical analyses for this end point

Secondary: Change from Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24

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End point title

Change from Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24

End point description

The change from baseline in UAS7 at Week 24 was calculated as UAS7 at Week 24 minus the baseline UAS7. UAS7 can range from 0 to 42.

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	170	88	82	90	86
Units: Score
arithmetic mean (standard deviation)	-23.08 ( 12.30 )	-24.96 ( 11.79 )	-23.55 ( 12.08 )	-24.50 ( 11.13 )	-22.48 ( 11.84 )

No statistical analyses for this end point

Secondary: Percentage of Patients with UAS7 of ≤ 6 points and complete responders at Week 12

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End point title

Percentage of Patients with UAS7 of ≤ 6 points and complete responders at Week 12

End point description

Percentage of patients with Weekly Urticaria Activity Score (UAS7) of ≤ 6 points and complete responders (UAS7 = 0) at Week 12 is presented. If a patient had missing weekly scores for the given week the patient was classified as a non-responder.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	203 ^[16]	205 ^[17]	107 ^[18]	103 ^[19]
Units: Patients
Patients with UAS7 ≤ 6	77	83	41	33
Patients with UAS7 = 0 (complete responder)	48	63	23	14

Notes
[16] - Patients with UAS7 ≤ 6 was 37.9% Patients with UAS7 = 0 was 23.6%
[17] - Patients with UAS7 ≤ 6 was 40.5% Patients with UAS7 = 0 was 30.7%
[18] - Patients with UAS7 ≤ 6 was 38.3% Patients with UAS7 = 0 was 21.5%
[19] - Patients with UAS7 ≤ 6 was 32.0% Patients with UAS7 = 0 was 13.6%

No statistical analyses for this end point

Secondary: Percentage of Patients with UAS7 of ≤ 6 points and complete responders at Week 24

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End point title

Percentage of Patients with UAS7 of ≤ 6 points and complete responders at Week 24

End point description

The number of patients with Weekly Urticaria Activity Score (UAS7) of ≤ 6 points and complete responders (UAS7 = 0) at Week 24 is presented. If a patient had missing weekly scores for the given week the patient was classified as a non-responder.

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	187 ^[20]	96 ^[21]	96 ^[22]	101 ^[23]	98 ^[24]
Units: Patients
Patients with UAS7 ≤ 6	102	65	46	55	41
Patients with UAS7 = 0 (complete responder)	75	49	36	39	31

Notes
[20] - Patients with UAS7 ≤ 6 was 54.5% Patients with UAS7 = 0 was 40.1%
[21] - Patients with UAS7 ≤ 6 was 67.7% Patients with UAS7 = 0 was 51.0%
[22] - Patients with UAS7 ≤ 6 was 47.9% Patients with UAS7 = 0 was 37.5%
[23] - Patients with UAS7 ≤ 6 was 54.5% Patients with UAS7 = 0 was 38.6%
[24] - Patients with UAS7 ≤ 6 was 41.8% Patients with UAS7 = 0 was 31.6%

No statistical analyses for this end point

Secondary: Number of Minimally Important Difference (MID) Responders in ISS7 by Week 12

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End point title

Number of Minimally Important Difference (MID) Responders in ISS7 by Week 12

End point description

Minimally important differece (MID) in ISS7 is a reduction of ≥ 5 points from baseline. The number of responders achieving MID response by Week 12 are presented.

End point type

Secondary

End point timeframe

Up to Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	203 ^[25]	205 ^[26]	107 ^[27]	103 ^[28]
Units: Responders	173	173	88	87

Notes
[25] - Percent of MID responders = 85.2%
[26] - Percent of MID responders = 84.4%
[27] - Percent of MID responders = 82.2%
[28] - Percent of MID responders = 84.5%

No statistical analyses for this end point

Secondary: Time to Minimally Important Difference (MID) in ISS7 by Week 12

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End point title

Time to Minimally Important Difference (MID) in ISS7 by Week 12

End point description

Time to MID response was the time (in weeks) from Day 1 to the study week when reduction of 5 points or more from baseline for ISS7 was first achieved up to Week 12. If a patient failed to achieve an MID response up to Week 12 or terminated the study prior to Week 12 without achieving MID response, the patient was censored at the date (in weeks) of the last non-missing ISS7 evaluation. Time to MID was estimated by Kaplan-Meier method.

End point type

Secondary

End point timeframe

Up to Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	203	205	107	103
Units: Weeks
median (confidence interval 95%)	2.00 (2.00 to 3.00)	2.00 (2.00 to 3.00)	2.00 (2.00 to 3.00)	2.00 (2.00 to 3.00)

No statistical analyses for this end point

Secondary: Change from Baseline in Weekly Hives Severity Score (HSS7) at Week 12

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End point title

Change from Baseline in Weekly Hives Severity Score (HSS7) at Week 12

End point description

The change from baseline in HSS7 at Week 12 was calculated as HSS7 at Week 12 minus the baseline HSS7. HSS7 can range from 0 to 21.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	186	192	101	94
Units: Score
arithmetic mean (standard deviation)	-9.96 ( 6.88 )	-10.55 ( 6.93 )	-10.29 ( 6.75 )	-9.48 ( 6.93 )

No statistical analyses for this end point

Secondary: Change from Baseline in Weekly Hives Severity Score (HSS7) at Week 24

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End point title

Change from Baseline in Weekly Hives Severity Score (HSS7) at Week 24

End point description

The change from baseline in HSS7 at Week 24 was calculated as HSS7 at Week 24 minus the baseline HSS7. HSS7 can range from 0 to 21.

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	170	88	82	90	86
Units: Score
arithmetic mean (standard deviation)	-11.86 ( 6.72 )	-12.72 ( 6.72 )	-12.36 ( 6.64 )	-12.74 ( 6.01 )	-11.77 ( 6.20 )

No statistical analyses for this end point

Secondary: Percentage of Angioedema-Free Days from Week 4 to Week 12

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End point title

Percentage of Angioedema-Free Days from Week 4 to Week 12

End point description

The proportion of angioedema-free days from Week 4 to Week 12 is defined as the number of days for which the patient indicated a ‘No’ response to the angioedema question in the patient eDiary divided by the total number of days with a non-missing diary entry starting on Week 4 visit date and ending the day prior to Week 12 visit date. Patients who had missing responses for > 40% of the daily diary entries between Week 4 visit date and Week 12 visit date were not included in this analysis.

End point type

Secondary

End point timeframe

From Week 4 to Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	189	190	99	97
Units: percent
arithmetic mean (standard deviation)	93.47 ( 17.95 )	90.14 ( 25.64 )	96.94 ( 10.83 )	93.77 ( 18.01 )

No statistical analyses for this end point

Secondary: Change from Baseline in Number of Tablets/Week of Rescue Therapy at Week 12

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End point title

Change from Baseline in Number of Tablets/Week of Rescue Therapy at Week 12

End point description

The change in the number of tablets/week of rescue therapy used from baseline at Week 12 is presented. The number of tablets for each week of rescue therapy will be defined as the sum of daily use of rescue therapy over the study days which make up a given study week. If a subject switched rescue therapy medication and started a different medication or the prescribed dose of the rescue therapy medication changed during the study, the subject was excluded from the summary.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	170	180	92	85
Units: tablets/week
arithmetic mean (standard deviation)	-1.33 ( 3.73 )	-1.45 ( 3.16 )	-1.19 ( 2.71 )	-1.53 ( 3.42 )

No statistical analyses for this end point

Secondary: Change from Baseline in Number of Tablets/Week of Rescue Therapy at Week 24

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End point title

Change from Baseline in Number of Tablets/Week of Rescue Therapy at Week 24

End point description

The change in the number of tablets/week of rescue therapy used from baseline at Week 24 is presented. The number of tablets for each week of rescue therapy will be defined as the sum of daily use of rescue therapy over the study days which make up a given study week. If a subject switched rescue therapy medication and started a different medication or the prescribed dose of the rescue therapy medication changed during the study, the subject was excluded from the summary.

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	154	78	79	81	78
Units: tablets/week
arithmetic mean (standard deviation)	-1.40 ( 3.79 )	-1.75 ( 3.67 )	-1.74 ( 2.98 )	-1.50 ( 3.36 )	-1.77 ( 3.33 )

No statistical analyses for this end point

Secondary: Trough Serum Concentration of Omalizumab at Week 12

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End point title

Trough Serum Concentration of Omalizumab at Week 12

End point description

The mean serum concentration of omalizumab for samples taken at Week 12, prior to the study drug administration, was summarized. All concentration below lower limit of quantification (BLQ) values were treated as zero (0) for PK parameter summary.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	187	193	101	97
Units: microgram/mL
arithmetic mean (standard deviation)	31.50791 ( 12.11966 )	31.35679 ( 13.44334 )	14.67465 ( 6.31588 )	15.80010 ( 7.65671 )

No statistical analyses for this end point

Secondary: Trough Serum Concentration of Omalizumab at Week 24

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End point title

Trough Serum Concentration of Omalizumab at Week 24

End point description

The mean serum concentration of omalizumab for samples taken at Week 24 End of Treatment Visit was summarized. All concentration below lower limit of quantification (BLQ) values were treated as zero (0) for PK parameter summary.

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	177	92	94	97	92
Units: microgram/mL
arithmetic mean (standard deviation)	35.43099 ( 14.98897 )	35.87102 ( 18.09287 )	33.50606 ( 14.25536 )	30.41523 ( 13.16691 )	33.63630 ( 16.55088 )

No statistical analyses for this end point

Secondary: Change from Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12

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End point title

Change from Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12

End point description

The change from baseline in mean overall DLQI score at Week 12 is presented. The DLQI is a 10-item dermatology-specific health-related questionnaire across 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 to 3. Overall DLQI ranges on a scale of 0 to 30.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	169	179	98	91
Units: Score
arithmetic mean (standard deviation)	-8.9 ( 7.5 )	-9.0 ( 6.7 )	-9.2 ( 7.0 )	-8.9 ( 8.2 )

No statistical analyses for this end point

Secondary: Change from Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24

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End point title

Change from Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24

End point description

The change from baseline in mean overall DLQI score at Week 24 is presented. The DLQI is a 10-item dermatology-specific health-related questionnaire across 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 to 3. Overall DLQI ranges on a scale of 0 to 30.

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	161	87	87	93	89
Units: Score
arithmetic mean (standard deviation)	-9.4 ( 6.9 )	-10.4 ( 7.3 )	-9.8 ( 6.9 )	-10.5 ( 7.7 )	-10.1 ( 7.5 )

No statistical analyses for this end point

Secondary: Change from Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12

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End point title

Change from Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12

End point description

The change from baseline in mean overall CU-Q2oL score at Week 12 is presented. The CU-Q2oL is a 23-item CSU specific health-related QoL questionnaire across 6 domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Patients rated their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question was scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115, was calculated by summing the individual raw domain scores. Overall raw scores of CU-Q2oL were converted to 0 to 100 point scores according to the following formula: [(sum of items – minimum) / (maximum – minimum)] × 100, where minimum=23 (1 score for all 23 items), maximum=115 (5 score for all 23 items).

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P39 300 mg	Xolair 300 mg	CT-P39 150 mg	Xolair 150 mg
Number of subjects analysed	178	186	100	94
Units: Score
arithmetic mean (standard deviation)	-25.40 ( 20.33 )	-28.11 ( 19.93 )	-27.32 ( 20.81 )	-26.51 ( 23.27 )

No statistical analyses for this end point

Secondary: Change from Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24

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End point title

Change from Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24

End point description

The change from baseline in mean overall CU-Q2oL score at Week 24 is presented. The CU-Q2oL is a 23-item CSU specific health-related QoL questionnaire across 6 domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Patients rated their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question was scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115, was calculated by summing the individual raw domain scores. Overall raw scores of CU-Q2oL were converted to 0 to 100 point scores according to the following formula: [(sum of items – minimum) / (maximum – minimum)] × 100, where minimum=23 (1 score for all 23 items), maximum=115 (5 score for all 23 items).

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P39 300 mg maintenance	Switched to CT-P39 300 mg	Xolair 300 mg maintenance	CT-P39 Dose increased	Xolair Dose increased
Number of subjects analysed	167	90	89	94	90
Units: Score
arithmetic mean (standard deviation)	-29.19 ( 18.76 )	-31.33 ( 21.95 )	-31.88 ( 22.33 )	-31.71 ( 19.96 )	-30.88 ( 22.22 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Treatment Period 1: TEAE with start date prior to the first study drug administration in TP2 Treatment Period 2: TEAE with start date from W12 administration to W24 (end of treatment visit) day Follow up Period: TEAE with start date after W24 visit

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.1

Reporting group title

Treatment Period 1: CT-P39 300 mg

Reporting group description

CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

Treatment Period 1: Xolair 300 mg

Reporting group description

Xolair 300 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

Treatment Period 1: CT-P39 150 mg

Reporting group description

CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

Treatment Period 1: Xolair 150 mg

Reporting group description

Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) (Weeks 0, 4, 8)

Reporting group title

Treatment Period 2: CT-P39 300 mg maintenance

Reporting group description

Received CT-P39 300 mg in TP1 and maintained on CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Treatment Period 2: Switched to CT-P39 300 mg

Reporting group description

Received Xolair 300 mg in TP1 and re-randomized to receive CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Treatment Period 2: Xolair 300 mg maintenance

Reporting group description

Received Xolair 300 mg in TP1 and re-randomized to continue on Xolair 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Treatment Period 2: CT-P39 Dose increased

Reporting group description

Received CT-P39 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Treatment Period 2: Xolair Dose increased

Reporting group description

Received Xolair 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; Xolair 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Follow up Period: CT-P39 300 mg maintenance

Reporting group description

Received CT-P39 300 mg in TP1 and maintained on CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Follow up Period: Switched from Xolair to CT-P39 300 mg

Reporting group description

Received Xolair 300 mg in TP1 and re-randomized to receive CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Follow up Period: Xolair 300 mg maintenance

Reporting group description

Received Xolair 300 mg in TP1 and re-randomized to continue on Xolair 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Follow up Period: CT-P39 Dose Increased

Reporting group description

Received CT-P39 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; CT-P39 300 mg in TP2 (Week 12, 16, 20)

Reporting group title

Follow up Period: Xolair Dose Increased

Reporting group description

Received Xolair 150 mg in TP1 and dose increased from 150 mg to 300 mg from Week 12; Xolair 300 mg in TP2 (Week 12, 16, 20)

Treatment Period 1: CT-P39 300 mg

Treatment Period 1: Xolair 300 mg

Treatment Period 1: CT-P39 150 mg

Treatment Period 1: Xolair 150 mg

Treatment Period 2: CT-P39 300 mg maintenance

Treatment Period 2: Switched to CT-P39 300 mg

Treatment Period 2: Xolair 300 mg maintenance

Treatment Period 2: CT-P39 Dose increased

Treatment Period 2: Xolair Dose increased

Follow up Period: CT-P39 300 mg maintenance

Follow up Period: Switched from Xolair to CT-P39 300 mg

Follow up Period: Xolair 300 mg maintenance

Follow up Period: CT-P39 Dose Increased

Follow up Period: Xolair Dose Increased

Total subjects affected by serious adverse events

subjects affected / exposed

4 / 203 (1.97%)

2 / 205 (0.98%)

2 / 107 (1.87%)

3 / 103 (2.91%)

5 / 187 (2.67%)

0 / 96 (0.00%)

2 / 96 (2.08%)

0 / 101 (0.00%)

0 / 98 (0.00%)

1 / 187 (0.53%)

3 / 96 (3.13%)

1 / 96 (1.04%)

3 / 101 (2.97%)

0 / 98 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Investigations

Tryptase increased

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

1 / 107 (0.93%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Papillary thyroid cancer

subjects affected / exposed

0 / 203 (0.00%)

1 / 205 (0.49%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ureteric cancer

subjects affected / exposed

0 / 203 (0.00%)

1 / 205 (0.49%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

1 / 96 (1.04%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Uterine leiomyoma

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

1 / 96 (1.04%)

0 / 96 (0.00%)

1 / 101 (0.99%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Joint dislocation

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

1 / 101 (0.99%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ligament sprain

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

1 / 96 (1.04%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Radius fracture

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

1 / 187 (0.53%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Behcet's syndrome

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

1 / 96 (1.04%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Myocardial ischaemia

subjects affected / exposed

1 / 203 (0.49%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Oedema peripheral

subjects affected / exposed

1 / 203 (0.49%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Colitis

subjects affected / exposed

1 / 203 (0.49%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Femoral hernia

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

1 / 103 (0.97%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemorrhoids

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

1 / 187 (0.53%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Cervical dysplasia

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

1 / 187 (0.53%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Menometrorrhagia

subjects affected / exposed

1 / 203 (0.49%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

1 / 187 (0.53%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vaginal haemorrhage

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

1 / 107 (0.93%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Completed suicide

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

1 / 187 (0.53%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Musculoskeletal and connective tissue disorders

Arthropathy

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

1 / 187 (0.53%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Appendicitis

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

1 / 96 (1.04%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

1 / 101 (0.99%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COVID-19

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

1 / 103 (0.97%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Chronic tonsillitis

subjects affected / exposed

0 / 203 (0.00%)

1 / 205 (0.49%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Coronavirus infection

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

1 / 103 (0.97%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infection

subjects affected / exposed

0 / 203 (0.00%)

0 / 205 (0.00%)

0 / 107 (0.00%)

0 / 103 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

0 / 101 (0.00%)

0 / 98 (0.00%)

0 / 187 (0.00%)

0 / 96 (0.00%)

1 / 96 (1.04%)

0 / 101 (0.00%)

0 / 98 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Treatment Period 1: CT-P39 300 mg	Treatment Period 1: Xolair 300 mg	Treatment Period 1: CT-P39 150 mg	Treatment Period 1: Xolair 150 mg	Treatment Period 2: CT-P39 300 mg maintenance	Treatment Period 2: Switched to CT-P39 300 mg	Treatment Period 2: Xolair 300 mg maintenance	Treatment Period 2: CT-P39 Dose increased	Treatment Period 2: Xolair Dose increased	Follow up Period: CT-P39 300 mg maintenance	Follow up Period: Switched from Xolair to CT-P39 300 mg	Follow up Period: Xolair 300 mg maintenance	Follow up Period: CT-P39 Dose Increased	Follow up Period: Xolair Dose Increased
Total subjects affected by non serious adverse events
subjects affected / exposed	23 / 203 (11.33%)	24 / 205 (11.71%)	16 / 107 (14.95%)	12 / 103 (11.65%)	18 / 187 (9.63%)	8 / 96 (8.33%)	11 / 96 (11.46%)	8 / 101 (7.92%)	5 / 98 (5.10%)	8 / 187 (4.28%)	11 / 96 (11.46%)	7 / 96 (7.29%)	9 / 101 (8.91%)	9 / 98 (9.18%)
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 203 (0.00%)	0 / 205 (0.00%)	3 / 107 (2.80%)	2 / 103 (1.94%)	0 / 187 (0.00%)	0 / 96 (0.00%)	0 / 96 (0.00%)	0 / 101 (0.00%)	0 / 98 (0.00%)	0 / 187 (0.00%)	0 / 96 (0.00%)	0 / 96 (0.00%)	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences all number	0	0	3	2	0	0	0	0	0	0	0	0	1	0
Headache
subjects affected / exposed	5 / 203 (2.46%)	5 / 205 (2.44%)	0 / 107 (0.00%)	4 / 103 (3.88%)	1 / 187 (0.53%)	1 / 96 (1.04%)	2 / 96 (2.08%)	0 / 101 (0.00%)	1 / 98 (1.02%)	2 / 187 (1.07%)	0 / 96 (0.00%)	0 / 96 (0.00%)	3 / 101 (2.97%)	1 / 98 (1.02%)
occurrences all number	6	6	0	4	1	1	3	0	1	2	0	0	3	1
General disorders and administration site conditions
Injection site reaction
subjects affected / exposed	5 / 203 (2.46%)	9 / 205 (4.39%)	1 / 107 (0.93%)	3 / 103 (2.91%)	1 / 187 (0.53%)	3 / 96 (3.13%)	2 / 96 (2.08%)	1 / 101 (0.99%)	1 / 98 (1.02%)	0 / 187 (0.00%)	0 / 96 (0.00%)	0 / 96 (0.00%)	0 / 101 (0.00%)	0 / 98 (0.00%)
occurrences all number	5	13	1	4	1	4	3	1	1	0	0	0	0	0
Immune system disorders
Immunisation reaction
subjects affected / exposed	0 / 203 (0.00%)	0 / 205 (0.00%)	1 / 107 (0.93%)	0 / 103 (0.00%)	0 / 187 (0.00%)	0 / 96 (0.00%)	2 / 96 (2.08%)	0 / 101 (0.00%)	0 / 98 (0.00%)	0 / 187 (0.00%)	0 / 96 (0.00%)	0 / 96 (0.00%)	0 / 101 (0.00%)	0 / 98 (0.00%)
occurrences all number	0	0	1	0	0	0	2	0	0	0	0	0	0	0
Infections and infestations
COVID-19
subjects affected / exposed	5 / 203 (2.46%)	7 / 205 (3.41%)	4 / 107 (3.74%)	1 / 103 (0.97%)	5 / 187 (2.67%)	2 / 96 (2.08%)	1 / 96 (1.04%)	2 / 101 (1.98%)	3 / 98 (3.06%)	2 / 187 (1.07%)	5 / 96 (5.21%)	3 / 96 (3.13%)	4 / 101 (3.96%)	5 / 98 (5.10%)
occurrences all number	5	7	4	1	5	2	1	2	3	2	5	3	4	5
Nasopharyngitis
subjects affected / exposed	7 / 203 (3.45%)	4 / 205 (1.95%)	7 / 107 (6.54%)	2 / 103 (1.94%)	6 / 187 (3.21%)	2 / 96 (2.08%)	4 / 96 (4.17%)	1 / 101 (0.99%)	0 / 98 (0.00%)	3 / 187 (1.60%)	4 / 96 (4.17%)	2 / 96 (2.08%)	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences all number	7	4	7	2	6	2	4	1	0	3	4	2	1	1
Tonsillitis
subjects affected / exposed	2 / 203 (0.99%)	1 / 205 (0.49%)	0 / 107 (0.00%)	0 / 103 (0.00%)	2 / 187 (1.07%)	0 / 96 (0.00%)	1 / 96 (1.04%)	0 / 101 (0.00%)	0 / 98 (0.00%)	0 / 187 (0.00%)	2 / 96 (2.08%)	0 / 96 (0.00%)	0 / 101 (0.00%)	0 / 98 (0.00%)
occurrences all number	2	1	0	0	2	0	1	0	0	0	2	0	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 203 (0.00%)	3 / 205 (1.46%)	1 / 107 (0.93%)	1 / 103 (0.97%)	3 / 187 (1.60%)	0 / 96 (0.00%)	0 / 96 (0.00%)	4 / 101 (3.96%)	1 / 98 (1.02%)	1 / 187 (0.53%)	0 / 96 (0.00%)	2 / 96 (2.08%)	0 / 101 (0.00%)	0 / 98 (0.00%)
occurrences all number	0	3	1	1	3	0	0	4	1	1	0	2	0	0
Metabolism and nutrition disorders
Hypertriglyceridaemia
subjects affected / exposed	0 / 203 (0.00%)	0 / 205 (0.00%)	0 / 107 (0.00%)	0 / 103 (0.00%)	0 / 187 (0.00%)	0 / 96 (0.00%)	0 / 96 (0.00%)	0 / 101 (0.00%)	0 / 98 (0.00%)	0 / 187 (0.00%)	0 / 96 (0.00%)	0 / 96 (0.00%)	1 / 101 (0.99%)	2 / 98 (2.04%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	2

More information

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Were there any global substantial amendments to the protocol? Yes

31 Aug 2020

• A secondary efficacy endpoint ‘Change from baseline in number of tablets/week of rescue therapy at Weeks 8, 12, and 24’ was added to address a possible imbalance in rescue therapy use between the treatment arms. • A patient was allowed to take additional H1-antihistamine in case a patient discontinued the study drug during the study treatment periods. • A patient had to return to the study center by regular scheduled time intervals even if a patient discontinued the study drug during the treatment period to apply treatment policy estimand. • The following statement “Back-up samples for PK, immunogenicity, and free IgE will be retained at the central laboratory as a back-up and blood samples for free IgE assessments can be used for additional analysis for either free or total IgE” was added. • History of and/or concomitant myocardial infarction’ was added to exclusion criteria considering myocardial infarction is specified as contraindications in Korea Ministry Food and Drug Safety label.

03 Sep 2020

• Details of analytical facilities was referred to the ICF instead of containing those details in the protocol. This change was done to prevent the protocol to be amended each time laboratory information is updated.

04 Nov 2020

• Immunogenicity timepoint was added to Weeks 4, 8, 16, and 20 to reflect FDA’s comment. • ‘Benefits and risk assessment and risk mitigation for COVID-19’ was added in accordance with Polish Ministry of Health. • Approval of omalizumab for the treatment of chronic rhinosinusitis with nasal polyps in Europe was updated.

10 Aug 2021

• The start time of background medication was changed to at least 3 days before start recording the baseline ISS7 which was the earliest valid efficacy data. • Risk assessment for concomitant use of a COVID-19 vaccine during the study was added. • ‘Patient missed at least 1 dose before Week 12’ was deleted from the study treatment discontinuation reason. • It was changed to allow the patients who showed positive result of antibody test due to the past hepatitis C infection to be enrolled in the study. • The description of conversion method for calculating rescue medications was added.

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.

Due to the global impact of the COVID-19 pandemic, the Sponsor took proactive measures for the safety of participants. Due to the war in Ukraine during the study, increase in protocol deviations was unavoidable and some procedures were changed.

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Clinical trials

Clinical Trial Results: A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1-antihistamine Treatment

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 12

Primary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 12

Secondary: Relative Potency of CT-P39 compared with Xolair

Secondary: Relative Potency of CT-P39 compared with Xolair

Secondary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 12

Secondary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 12

Secondary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 24

Secondary: Change from Baseline in Weekly Itch Severity Score (ISS7) at Week 24

Secondary: Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12

Secondary: Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12

Secondary: Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 24

Secondary: Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 24

Secondary: Change from Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

Secondary: Change from Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

Secondary: Change from Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24

Secondary: Change from Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24

Secondary: Percentage of Patients with UAS7 of ≤ 6 points and complete responders at Week 12

Secondary: Percentage of Patients with UAS7 of ≤ 6 points and complete responders at Week 12

Secondary: Percentage of Patients with UAS7 of ≤ 6 points and complete responders at Week 24

Secondary: Percentage of Patients with UAS7 of ≤ 6 points and complete responders at Week 24

Secondary: Number of Minimally Important Difference (MID) Responders in ISS7 by Week 12

Secondary: Number of Minimally Important Difference (MID) Responders in ISS7 by Week 12

Secondary: Time to Minimally Important Difference (MID) in ISS7 by Week 12

Secondary: Time to Minimally Important Difference (MID) in ISS7 by Week 12

Secondary: Change from Baseline in Weekly Hives Severity Score (HSS7) at Week 12

Secondary: Change from Baseline in Weekly Hives Severity Score (HSS7) at Week 12

Secondary: Change from Baseline in Weekly Hives Severity Score (HSS7) at Week 24

Secondary: Change from Baseline in Weekly Hives Severity Score (HSS7) at Week 24

Secondary: Percentage of Angioedema-Free Days from Week 4 to Week 12

Secondary: Percentage of Angioedema-Free Days from Week 4 to Week 12

Secondary: Change from Baseline in Number of Tablets/Week of Rescue Therapy at Week 12

Secondary: Change from Baseline in Number of Tablets/Week of Rescue Therapy at Week 12

Secondary: Change from Baseline in Number of Tablets/Week of Rescue Therapy at Week 24

Secondary: Change from Baseline in Number of Tablets/Week of Rescue Therapy at Week 24

Secondary: Trough Serum Concentration of Omalizumab at Week 12

Secondary: Trough Serum Concentration of Omalizumab at Week 12

Secondary: Trough Serum Concentration of Omalizumab at Week 24

Secondary: Trough Serum Concentration of Omalizumab at Week 24

Secondary: Change from Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12

Secondary: Change from Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12

Secondary: Change from Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24

Secondary: Change from Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24

Secondary: Change from Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12

Secondary: Change from Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12

Secondary: Change from Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24

Secondary: Change from Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1-antihistamine Treatment