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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Chronic Urticaria

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04976192

TV45779-IMB-30086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 608 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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608 participants in 10 patient groups

TEV-45779-300 mg Main Treatment period

Experimental group

Description:

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

Treatment:

Combination Product: TEV-45779

Xolair-300 mg Main Treatment Period

Active Comparator group

Description:

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

Treatment:

Combination Product: XOLAIR® Injection

TEV-45779-150 mg Main Treatment period

Experimental group

Description:

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

Treatment:

Combination Product: TEV-45779

Xolair-150 mg Main Treatment Period

Active Comparator group

Description:

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

Treatment:

Combination Product: XOLAIR® Injection

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

Experimental group

Description:

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.

Treatment:

Combination Product: TEV-45779

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

Experimental group

Description:

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.

Treatment:

Combination Product: TEV-45779

Combination Product: XOLAIR® Injection

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

Active Comparator group

Description:

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.

Treatment:

Combination Product: XOLAIR® Injection

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

Experimental group

Description:

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.

Treatment:

Combination Product: TEV-45779

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

Experimental group

Description:

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.

Treatment:

Combination Product: TEV-45779

Combination Product: XOLAIR® Injection

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

Active Comparator group

Description:

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.

Treatment:

Combination Product: XOLAIR® Injection