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

NCT04976192 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: TV45779-IMB-300862021-001796-17
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Chronic Urticaria

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For European Medicines Agency [EMA] Submission)

  The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. Least square (LS) mean and 95% confidence interval (CI) were calculated using analysis of covariance (ANCOVA) model. Multiple imputation performed both for the participants having missing ISS7 at week 12 and for participants using any disallowed concomitant medication.

  Baseline, Week 12

• 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)

  The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. LS mean and 90% CI were calculated using ANCOVA model. Multiple imputation performed for the participants having missing ISS7 at week 12.

  Baseline, Week 12

Secondary Outcomes (22)

• Change From Baseline in the ISS7 at Weeks 4 and 12

  Baseline, Weeks 4 and 12

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

  Baseline, Week 12

• Percentage of Participants With a UAS7 Score ≤6 at Week 12

  Week 12

• Percentage of Complete Responders (UAS7 Score = 0) at Week 12

  Week 12

• Change From Baseline in the Physician's (In-clinic) Assessment of UAS at Week 12

  Baseline, Week 12

Study Arms (10)

TEV-45779-300 mg Main Treatment period

EXPERIMENTAL

TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8

Combination Product: TEV-45779

Xolair-300 mg Main Treatment Period

ACTIVE COMPARATOR

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8

Combination Product: XOLAIR® Injection

TEV-45779-150 mg Main Treatment period

EXPERIMENTAL

TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8

Combination Product: TEV-45779

Xolair-150 mg Main Treatment Period

ACTIVE COMPARATOR

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8

Combination Product: XOLAIR® Injection

TEV-45779-300 mg Main / TEV45779-300 mg Transition Period

EXPERIMENTAL

TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to TEV-45779-300 mg in the Main Treatment period.

Combination Product: TEV-45779

Xolair-300 mg Main / TEV45779-300 mg Transition Period

EXPERIMENTAL

TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to Xolair-300 mg in the main treatment period.

Combination Product: TEV-45779; Combination Product: XOLAIR® Injection

Xolair-300 mg Main / Xolair-300 mg Transition Period

ACTIVE COMPARATOR

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to Xolair-300 mg in the main treatment period.

Combination Product: XOLAIR® Injection

TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period

EXPERIMENTAL

TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to TEV-45779-150 mg in the main treatment period.

Combination Product: TEV-45779

Xolair-150 mg Main / TEV-45779-150 mg Transition Period

EXPERIMENTAL

TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to XOLAIR-150 mg in the main treatment period.

Combination Product: TEV-45779; Combination Product: XOLAIR® Injection

Xolair-150 mg Main / Xolair-150 mg Transition Period

ACTIVE COMPARATOR

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to XOLAIR -150 mg in the main treatment period.

Combination Product: XOLAIR® Injection

Interventions

TEV-45779 COMBINATION_PRODUCT

TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe

TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period; TEV-45779-150 mg Main Treatment period; TEV-45779-300 mg Main / TEV45779-300 mg Transition Period; TEV-45779-300 mg Main Treatment period; Xolair-150 mg Main / TEV-45779-150 mg Transition Period; Xolair-300 mg Main / TEV45779-300 mg Transition Period

XOLAIR® Injection COMBINATION_PRODUCT

XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.

Xolair-150 mg Main / TEV-45779-150 mg Transition Period; Xolair-150 mg Main / Xolair-150 mg Transition Period; Xolair-150 mg Main Treatment Period; Xolair-300 mg Main / TEV45779-300 mg Transition Period; Xolair-300 mg Main / Xolair-300 mg Transition Period; Xolair-300 mg Main Treatment Period

Eligibility Criteria

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

You may qualify if:

• Diagnosis of CIU refractory to H1 antihistamines for ≥3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead
• Teva Pharmaceuticals Development, Inc.: collaborator

Study Sites (9)

10008

Bakersfield, California, 93301, United States

Location

Site 10001

Clearwater, Florida, 33765, United States

Location

10012

Coral Gables, Florida, 33134, United States

Location

10006

Kissimmee, Florida, 34744, United States

Location

10014

Maitland, Florida, 32751, United States

Location

10005

Miami, Florida, 33014, United States

Location

10009

Tampa, Florida, 33613, United States

Location

10007

Troy, Michigan, 48084, United States

Location

10004

Salt Lake City, Utah, 84117, United States

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: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Pharmaceuticals Development, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: July 14, 2021
• First Posted: July 26, 2021
• Study Start: August 30, 2021
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: October 7, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)