Phase 3
N=619
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT04426890 ↗Enrolled (actual)
619
Serious AEs
1.4%
Results posted
Jul 2025
Primary outcome: Primary: Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups — -9.25; -9.96 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CT-P39 (Biological); EU-approved Xolair (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Celltrion
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups |
-9.25; -9.96 | — |
| PRIMARY Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 |
NA; NA; NA; NA | — |
| SECONDARY Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 |
-9.31; -9.99; -9.56; -8.73 | — |
| SECONDARY Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 24 |
-11.22; -12.24; -11.19; -11.76; -10.70 | — |
| SECONDARY Time to Minimally Important Difference (MID) in ISS7 by Week 12 |
2.00; 2.00; 2.00; 2.00 | — |
| SECONDARY Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12 |
141; 152; 78; 65 | — |
| SECONDARY Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 |
-9.96; -10.55; -10.29; -9.48 | — |
| SECONDARY Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 24 |
-11.86; -12.72; -12.36; -12.74; -11.77 | — |
| SECONDARY Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 |
-19.27; -20.54; -19.84; -18.21 | — |
| SECONDARY Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24 |
-23.08; -24.96; -23.55; -24.50; -22.48 | — |
| SECONDARY Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 12 |
77; 83; 41; 33; 48; 63 | — |
| SECONDARY Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 24 |
102; 65; 46; 55; 41; 75 | — |
| SECONDARY Percentage of Angioedema-Free Days From Week 4 to Week 12 |
93.47; 90.14; 96.94; 93.77 | — |
| SECONDARY Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 12 |
-1.33; -1.45; -1.19; -1.53 | — |
| SECONDARY Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 24 |
-1.40; -1.75; -1.74; -1.50; -1.77 | — |
| SECONDARY Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 |
-8.9; -9.0; -9.2; -8.9 | — |
| SECONDARY Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24 |
-9.4; -10.4; -9.8; -10.5; -10.1 | — |
| SECONDARY Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12 |
-25.40; -28.11; -27.32; -26.51 | — |
| SECONDARY Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24 |
-29.19; -31.33; -31.88; -31.71; -30.88 | — |
| SECONDARY Trough Serum Concentration (Ctrough) of Omalizumab at Week 12 |
31.50791; 31.35679; 14.67465; 15.80010 | — |
| SECONDARY Trough Serum Concentration (Ctrough) of Omalizumab at Week 24 |
35.43099; 35.87102; 33.50606; 30.41523; 33.63630 | — |
| SECONDARY Immunogenicity Result at Week 12 |
1; 0; 2; 0; 1; 0 | — |
| SECONDARY Immunogenicity Result at Week 24 |
9; 2; 0; 4; 1; 2 | — |
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
Eligibility Criteria
Inclusion Criteria
- Diagnosed with CSU
- Diagnosed as CSU refractory to H1-antihistamine
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04426890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.