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NCT04976192 | COMPLETED | Chronic Urticaria


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

Teva Pharmaceuticals USA

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.

Condition or disease

Chronic Urticaria

Intervention/treatment

TEV-45779

XOLAIR® Injection

Phase

PHASE3

Detailed Description:

This is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TEV-45779 compared to XOLAIR administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks (6 treatments) in patients with Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. This study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. The total duration of the study is up to 42 weeks. At baseline, patients will be randomized in a 2:2:1:1 ratio to receive the first 3 treatments of TEV-45779 300 mg, XOLAIR 300 mg, TEV-45779 150 mg or XOLAIR 150 mg (main treatment period). At Week 12, prior to receiving their fourth dose of study medication, patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 1:1 to receive 3 additional doses of XOLAIR (at the same dose level as prior to randomization, or switch to 3 doses of TEV-45779 (transition period) at the same dose level as prior to randomization. All patients in the TEV-45779 groups will continue to receive TEV-45779 at the same dose levels.

Study Type : INTERVENTIONAL
Estimated Enrollment : 608 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Study to Evaluate the Efficacy, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to XOLAIR (Omalizumab) in Patients With Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine (H1) Treatment.
Actual Study Start Date : 2021-08-30
Estimated Primary Completion Date : 2024-04-05
Estimated Study Completion Date : 2024-04-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT04976192


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Locations


Not yet recruiting

United States, California

10008

Bakersfield, California, United States, 93301

Not yet recruiting

United States, Florida

Site 10001

Clearwater, florida, United States, 33765

Not yet recruiting

United States, Florida

10012

Coral Gables, florida, United States, 33134

Not yet recruiting

United States, Florida

10006

Kissimmee, florida, United States, 34744

Not yet recruiting

United States, Florida

10014

Maitland, florida, United States, 32751

Not yet recruiting

United States, Florida

10005

Miami, florida, United States, 33014

Not yet recruiting

United States, Florida

10009

Tampa, florida, United States, 33613

Not yet recruiting

United States, road cancer

10007

Troy, road cancer, United States, 48084

Not yet recruiting

United States, Utah

10004

Salt Lake City, Utah, United States, 84117

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