Clinical trial NCT04976192: Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Urticaria
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceuticals Development, Inc.
First posted: 2021-07-26
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change from baseline in the ISS7 at Week 12 between TEV 45779 300 mg and XOLAIR 300 mg
timeFrame: Baseline and week 12
measure: Relative potency of TEV 45779 and XOLAIR
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change from baseline in the ISS7 at Week 12
timeFrame: Baseline, week 4 and week 12
measure: Change from baseline in the UAS7 at Week 12
timeFrame: Baseline and week 12
measure: Percentage of patients with a UAS7 ≤6 at Week 12
timeFrame: week 12
measure: Percentage of complete responders (UAS7=0) at Week 12
timeFrame: week 12
measure: Change from baseline in the physician's (in-clinic) assessment of UAS7 at Week 12
timeFrame: Baseline and week 12
measure: Change from baseline in the weekly number of wheals score at Week 12
timeFrame: Baseline and week 12
measure: Change from baseline in the weekly size of the largest wheals score at Week 12
timeFrame: Baseline and week 12
measure: Time to MID response in ISS7 score by Week 12
timeFrame: Baseline till week 12
measure: Percentage of ISS7 MID responders at Week 12
timeFrame: Baseline and week 12
measure: Percentage of angioedema-free days from Week 4 to Week 12
timeFrame: week 4 and week 12
measure: Change from baseline in the overall DLQI score at Week 12
timeFrame: Baseline and week 12
measure: Change from Week 12 in ISS7 at Week 24
timeFrame: week 12 and week 24
measure: Change from Week 12 in ISS7 at Week 40
timeFrame: week 12 and week 40
measure: Change from Week 12 in the UAS7 at Week 24
timeFrame: week 12 and week 24
measure: Change from Week 12 in the physician's (in-clinic) assessment of UAS7 at Week 24
timeFrame: week 12 and week 24
measure: Change from Week 12 in the weekly number of wheals score at Week 24
timeFrame: week 12 and week 24
measure: Change from Week 12 in the weekly number of wheals score at Week 40
timeFrame: week 12 and week 40
measure: Change from Week 12 in the weekly number of the largest wheals score at Week 24
timeFrame: week 12 and week 24
measure: Change from Week 12 in the weekly number of the largest wheals score at Week 40
timeFrame: week 12 and week 40
measure: Percentage of angioedema-free days from Week 12 to Week 24
timeFrame: week 12 and week 24
measure: Change from Week 12 in the overall DLQI score at Week 24
timeFrame: week 12 and week 24
measure: Change from Week 12 in the overall DLQI score at Week 40
timeFrame: week 12 and week 40
measure: Incidence of adverse event and withdrawals due to adverse events in the main period
timeFrame: Baseline till week 12
measure: Incidence of adverse event in the transition and follow up period
timeFrame: week 12 till week 40
measure: Incidence of antidrug antibodies (ADAs) in the main treatment period
timeFrame: Baseline till week 12
measure: Incidence of antidrug antibodies (ADAs) in the transition and follow up period
timeFrame: week 12 till week 40
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: 10008
state: California
city: Clearwater
country: United States
facility: Site 10001
state: Florida
city: Coral Gables
country: United States
facility: 10012
state: Florida
city: Kissimmee
country: United States
facility: 10006
state: Florida
city: Maitland
country: United States
facility: 10014
state: Florida
city: Miami
country: United States
facility: 10005
state: Florida
city: Tampa
country: United States
facility: 10009
state: Florida
city: Troy
country: United States
facility: 10007
state: Michigan
city: Salt Lake City
country: United States
facility: 10004
state: Utah
Study officials:
affiliation: Teva Pharmaceuticals Development, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: