Phase 3 N=608 Randomized Quadruple-blind Treatment

Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Chronic Urticaria

Bottom Line

View on ClinicalTrials.gov: NCT04976192 ↗

Enrolled (actual)

608

Serious AEs

1.4%

Results posted

Oct 2025

Primary outcome: Primary: Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For European Medicines Agency [EMA] Submission) — -10.92; -10.61 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TEV-45779 (Combination_product); XOLAIR® Injection (Combination_product)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Teva Pharmaceuticals USA
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For European Medicines Agency [EMA] Submission)	-10.92; -10.61	—
PRIMARY Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For Food and Drug Administration [FDA] Submission)	-10.77; -10.38	—
SECONDARY Change From Baseline in the ISS7 at Weeks 4 and 12	-7.64; -7.35; -7.87; -7.27; -10.92; -9.96	—
SECONDARY Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12	-22.10; -20.67; -21.73; -21.67	—
SECONDARY Percentage of Participants With a UAS7 Score ≤6 at Week 12	49.5; 45.8; 46.4; 48.5	—
SECONDARY Percentage of Complete Responders (UAS7 Score = 0) at Week 12	33.2; 28.1; 29.6; 30.9	—
SECONDARY Change From Baseline in the Physician's (In-clinic) Assessment of UAS at Week 12	-3.38; -3.34; -3.55; -3.15	—
SECONDARY Change From Baseline in the Weekly Number of Wheals Score at Week 12	-11.18; -10.70; -11.09; -11.33	—
SECONDARY Change From Baseline in the Weekly Size of the Largest Wheals Score at Week 12	-10.28; -9.52; -10.45; -10.68	—
SECONDARY Time to Minimally Important Difference (MID) Response in ISS7 Score	2.0; 2.0; 2.0; 2.0	—
SECONDARY Percentage of ISS7 MID Responders at Week 12	81.0; 78.1; 80.6; 79.4	—
SECONDARY Percentage of Angioedema-Free Days From Week 4 to Week 12	100.00; 100.00; 100.00; 100.00	—
SECONDARY Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12	-9.72; -8.40; -9.54; -8.09	—
SECONDARY Change From Week 12 in ISS7 at Weeks 24 and 40	-1.64; -1.37; -1.82; -1.21; -1.78; -2.09	—
SECONDARY Change From Week 12 in the UAS7 at Week 24	-3.37; -2.66; -3.65; -2.54; -3.45; -3.12	—
SECONDARY Change From Week 12 in the Physician's (In-clinic) Assessment of UAS7 at Week 24	-0.55; -0.40; -0.27; -0.53; -0.38; -0.67	—
SECONDARY Change From Week 12 in the Weekly Number of Wheals Score at Weeks 24 and 40	-1.73; -1.29; -1.84; -1.33; -1.67; -1.03	—
SECONDARY Change From Week 12 in the Weekly Size of the Largest Wheals Score at Weeks 24 and 40	-1.87; -1.28; -1.78; -1.18; -1.94; -0.88	—
SECONDARY Percentage of Angioedema-Free Days From Week 12 to Week 24	100.00; 100.00; 100.00; 100.00; 100.00; 100.00	—
SECONDARY Change From Week 12 in the Overall DLQI Score at Weeks 24 and 40	-1.44; -0.43; -1.19; -1.82; -0.88; -1.60	—
SECONDARY Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) in the Main Treatment Period	64; 37; 71; 33	—
SECONDARY Number of Participants With at Least One TEAE Week 12 up to Week 24	78; 34; 43; 18; 38; 16	—
SECONDARY Number of Participants With Antidrug Antibodies (ADAs) in the Main Treatment Period	18; 6; 37; 13; 8; 5	—
SECONDARY Number of Participants With ADAs From Week 12 to Week 24	34; 15; 10; 4; 14; 8	—

Summary

The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment.

Eligibility Criteria

Inclusion Criteria

Diagnosis of CIU refractory to H1 antihistamines for ≥3 months

Exclusion Criteria

Chronic urticaria with clearly defined underlying etiology
Other skin disease associated with itch
Evidence of parasitic infection on stool evaluation for ova and parasites
History of anaphylactic shock
Hypersensitivity to omalizumab or any component of the formulation
Required background therapy with other than protocol-defined antihistamines
Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04976192). 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.