Clinical trial

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.

Name

TV45779-IMB-30086

Description

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.

Trial arms

Trial start

2021-08-30

Estimated PCD

2023-09-19

Trial end

2024-04-05

Status

Completed

Phase

Early phase I

Treatment

TEV-45779

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

Arms:

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

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

Arms:

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

Size

608

Primary endpoint

Change from baseline in the ISS7 at Week 12 between TEV 45779 300 mg and XOLAIR 300 mg

Baseline and week 12

Relative potency of TEV 45779 and XOLAIR

Baseline and week 12

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 608, 'type': 'ACTUAL'}}

Updated at

2024-04-15

1 organization

2 products

1 indication

Organization

Product

Indication

Product