To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

NCT04426890 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CT-P39 3.12020-000952-36
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Spontaneous Urticaria

Keywords

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (2)

• Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups

  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 ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. 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.

  Week 12

• Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12

  The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency was not calculated due to the assumption of parallel-line assay not being met. A parallel-line assay assumes that dose-efficacy response relationships are linear and parallel on log-dose scale which requires the equal slope in the regression model used to estimate relative potency. However, the slopes of the two treatment groups were estimated to be different, indicating a violation of the parallelism assumption. As a result, the relative potency was not computed.

  Week 12

Secondary Outcomes (21)

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

  Week 12

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

  Week 24

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

  Up to Week 12

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

  Week 12

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

  Week 12

Study Arms (6)

Arm 1

EXPERIMENTAL

Planned to receive CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) and maintain CT-P39 300 mg in TP2

Biological: CT-P39

Arm 2

ACTIVE COMPARATOR

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized at Week 12 to Arm 2-1 or Arm 2-2

Biological: EU-approved Xolair

Arm 2-1

ACTIVE COMPARATOR

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized to switch to CT-P39 300 mg in TP2

Biological: CT-P39; Biological: EU-approved Xolair

Arm 2-2

ACTIVE COMPARATOR

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized to maintain Xolair 300 mg in TP2

Biological: EU-approved Xolair

Arm 3

EXPERIMENTAL

Planned to receive CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) and increase to CT-P39 300 mg in TP2

Biological: CT-P39

Arm 4

ACTIVE COMPARATOR

Planned to receive Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) and increase to Xolair 300 mg in TP2

Biological: EU-approved Xolair

Interventions

CT-P39 BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

Also known as: Omalizumab

Arm 1; Arm 2-1; Arm 3

EU-approved Xolair BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

Also known as: Omalizumab

Arm 2; Arm 2-1; Arm 2-2; Arm 4

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with CSU
• Diagnosed as CSU refractory to H1-antihistamine

You may not qualify if:

• Chronic urticaria with clearly defined underlying etiology
• Clinically significant allergic reaction and/or hypersensitivity to any component of omalizumab
• History of anaphylactic shock
• History of and/or concomitant immune complex disease (including Type III hypersensitivity)
• Parasitic diseases or colonization on stool evaluation for ova and parasites
• Unable to receive background therapy with protocol-defined antihistamines or contraindicated to epinephrine

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Klinika Ambroziak ESTEDERM

Warsaw, Poland

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Yunju Bae/Head of Clinical Planning 1 Department
• Organization: Celltrion. Inc

Yunju.bae@celltrion.com

+82 32 850 4160

Study Officials

• MinJi Ma

  Celltrion, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: December 9, 2020
• Primary Completion: October 21, 2022
• Study Completion: April 27, 2023
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Locations

PL (1)