- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04976192
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
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 Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: MD Teva U.S. Medical Information
- Phone Number: 1-888-483-8279
- Email: USMedInfo@tevapharm.com
Study Locations
-
-
California
-
Bakersfield, California, United States, 93301
- 10008
-
-
Florida
-
Clearwater, Florida, United States, 33765
- Site 10001
-
Coral Gables, Florida, United States, 33134
- 10012
-
Kissimmee, Florida, United States, 34744
- 10006
-
Maitland, Florida, United States, 32751
- 10014
-
Miami, Florida, United States, 33014
- 10005
-
Tampa, Florida, United States, 33613
- 10009
-
-
Michigan
-
Troy, Michigan, United States, 48084
- 10007
-
-
Utah
-
Salt Lake City, Utah, United States, 84117
- 10004
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TEV-45779-300 mg Main Treatment period
TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8
|
TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
|
Active Comparator: Xolair-300 mg Main Treatment Period
XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8
|
XOLAIR (omalizumab) injection is supplied as a single dose PFS.
Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.
|
Experimental: TEV-45779-150 mg Main Treatment period
TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8
|
TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
|
Active Comparator: Xolair-150 mg Main Treatment Period
XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8
|
XOLAIR (omalizumab) injection is supplied as a single dose PFS.
Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.
|
Experimental: TEV-45779-300 mg Main / TEV45779-300 mg Transition Period
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.
|
TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
|
Experimental: Xolair-300 mg Main / TEV45779-300 mg Transition Period
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.
|
TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
XOLAIR (omalizumab) injection is supplied as a single dose PFS.
Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.
|
Active Comparator: Xolair-300 mg Main / Xolair-300 mg Transition Period
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.
|
XOLAIR (omalizumab) injection is supplied as a single dose PFS.
Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.
|
Experimental: TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period
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.
|
TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
|
Experimental: Xolair-150 mg Main / TEV-45779-150 mg Transition Period
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.
|
TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
XOLAIR (omalizumab) injection is supplied as a single dose PFS.
Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.
|
Active Comparator: Xolair-150 mg Main / Xolair-150 mg Transition Period
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.
|
XOLAIR (omalizumab) injection is supplied as a single dose PFS.
Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in the ISS7 at Week 12 between TEV 45779 300 mg and XOLAIR 300 mg
Time Frame: Baseline and week 12
|
ISS 7 is a weekly itch severity score calculated as sum of the daily itch severity score for 7 days, on a scale of 0 to 3 (0=none to 3=intense/severe).
|
Baseline and week 12
|
Relative potency of TEV 45779 and XOLAIR
Time Frame: Baseline and week 12
|
Relative potency TEV45779 to the Xolair defined as the dose of TEV45779 that produces the same biological response as one unit of the dose of the Xolair. The relative potency and its CI will be measured by change in ISS7 at Week 12 using a 4 point assay based on the 300 mg and 150 mg dose levels of each product. |
Baseline and week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in the ISS7 at Week 12
Time Frame: Baseline, week 4 and week 12
|
ISS 7 is a weekly itch severity score calculated as sum of the daily itch severity score for 7 days, on a scale of 0 to 3 (0=none to 3=intense/severe).
|
Baseline, week 4 and week 12
|
Change from baseline in the UAS7 at Week 12
Time Frame: Baseline and week 12
|
Change from baseline in the Urticaria Activity Score (UAS) - sum of the daily number of wheals score and itch severity score over 7 days, range from 0 (minimum) to 6 (maximum)) at Week 12.
|
Baseline and week 12
|
Percentage of patients with a UAS7 ≤6 at Week 12
Time Frame: week 12
|
Percentage of patients with a weekly Urticaria Activity Score ≤6 at Week 12
|
week 12
|
Percentage of complete responders (UAS7=0) at Week 12
Time Frame: week 12
|
Percentage of complete responders with weekly Urticaria Activity Score =0 at Week 12
|
week 12
|
Change from baseline in the physician's (in-clinic) assessment of UAS7 at Week 12
Time Frame: Baseline and week 12
|
Change from baseline in the physician's (in-clinic) assessment of weekly Urticaria Activity Score at Week 12.
|
Baseline and week 12
|
Change from baseline in the weekly number of wheals score at Week 12
Time Frame: Baseline and week 12
|
Change from baseline in the weekly number of wheals score at Week 12
|
Baseline and week 12
|
Change from baseline in the weekly size of the largest wheals score at Week 12
Time Frame: Baseline and week 12
|
Change from baseline in the weekly size of the largest wheals score at Week 12
|
Baseline and week 12
|
Time to MID response in ISS7 score by Week 12
Time Frame: Baseline till week 12
|
Time to minimally important difference (MID) defined as a reduction from baseline in ISS7 of ≥5 points) response in ISS7 score by Week 12
|
Baseline till week 12
|
Percentage of ISS7 MID responders at Week 12
Time Frame: Baseline and week 12
|
Percentage of patients with minimally important difference defined as reduction of ≥5 points from baseline in ISS7 at Week 12.
|
Baseline and week 12
|
Percentage of angioedema-free days from Week 4 to Week 12
Time Frame: week 4 and week 12
|
Percentage of angioedema-free days from Week 4 to Week 12
|
week 4 and week 12
|
Change from baseline in the overall DLQI score at Week 12
Time Frame: Baseline and week 12
|
Change from baseline in the overall dermatology life quality index (DLQI) score at Week 12; comparisons of TEV 45779 and XOLAIR treatment arms.
The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week.
The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired
|
Baseline and week 12
|
Change from Week 12 in ISS7 at Week 24
Time Frame: week 12 and week 24
|
Change from Week 12 in ISS7 at Week 24
|
week 12 and week 24
|
Change from Week 12 in ISS7 at Week 40
Time Frame: week 12 and week 40
|
Change from Week 12 in ISS7 at Week 40.
|
week 12 and week 40
|
Change from Week 12 in the UAS7 at Week 24
Time Frame: week 12 and week 24
|
Change from Week 12 in the UAS7 (sum of the daily number of wheals score and itch severity score over 7 days) at Week 24.
|
week 12 and week 24
|
Change from Week 12 in the physician's (in-clinic) assessment of UAS7 at Week 24
Time Frame: week 12 and week 24
|
Change from Week 12 in the physician's (in-clinic) assessment of UAS7 at Week 24
|
week 12 and week 24
|
Change from Week 12 in the weekly number of wheals score at Week 24
Time Frame: week 12 and week 24
|
Change from Week 12 in the weekly number of wheals score at Week 24.
|
week 12 and week 24
|
Change from Week 12 in the weekly number of wheals score at Week 40
Time Frame: week 12 and week 40
|
Change from Week 12 in the weekly number of wheals score at Week 40.
|
week 12 and week 40
|
Change from Week 12 in the weekly number of the largest wheals score at Week 24
Time Frame: week 12 and week 24
|
Change from Week 12 in the weekly number of the largest wheals score at Week 24.
|
week 12 and week 24
|
Change from Week 12 in the weekly number of the largest wheals score at Week 40
Time Frame: week 12 and week 40
|
Change from Week 12 in the weekly number of the largest wheals score at Week 40.
|
week 12 and week 40
|
Percentage of angioedema-free days from Week 12 to Week 24
Time Frame: week 12 and week 24
|
Percentage of angioedema-free days from Week 12 to Week 24
|
week 12 and week 24
|
Change from Week 12 in the overall DLQI score at Week 24
Time Frame: week 12 and week 24
|
Change from Week 12 in the overall dermatology life quality index (DLQI) score at Week 24
|
week 12 and week 24
|
Change from Week 12 in the overall DLQI score at Week 40
Time Frame: week 12 and week 40
|
Change from Week 12 in the overall dermatology life quality index (DLQI) score at Week 40
|
week 12 and week 40
|
Incidence of adverse event and withdrawals due to adverse events in the main period
Time Frame: Baseline till week 12
|
Number of patients reporting at least one treatment-emergent adverse event up to week 12
|
Baseline till week 12
|
Incidence of adverse event in the transition and follow up period
Time Frame: week 12 till week 40
|
Number of patients reporting at least one treatment-emergent adverse event from week 12 till week 40
|
week 12 till week 40
|
Incidence of antidrug antibodies (ADAs) in the main treatment period
Time Frame: Baseline till week 12
|
Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline up to week 12
|
Baseline till week 12
|
Incidence of antidrug antibodies (ADAs) in the transition and follow up period
Time Frame: week 12 till week 40
|
Number of patients with confirmed positive antidrug antibodies (ADAs) post-week 12 up to week 40
|
week 12 till week 40
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Teva Medical Expert, MD, Teva Pharmaceuticals Development, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TV45779-IMB-30086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Urticaria
-
Marcus MaurerCompletedNon-autoreactive Chronic Spontaneous Urticaria | Autoimmune Chronic Spontaneous Urticaria | Autoreactive, Non-autoimmune Chronic Spontaneous UrticariaGermany
-
United BioPharmaCompleted
-
University Hospital, LilleRecruitingSpontaneous Urticaria, ChronicFrance
-
United BioPharmaNot yet recruiting
-
Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedUrticaria ChronicUnited States
-
Novartis PharmaceuticalsCompletedCHRONIC SPONTANEOUS URTICARIAFrance
-
University Hospital Inselspital, BerneNovartis; University of Bern; Adverse Drug Reactions, Advice and Consulting ADR-ACCompletedChronic Idiopathic Urticaria | Chronic Urticaria | Chronic Spontaneous UrticariaSwitzerland
-
J. Uriach and CompanyTerminated
-
Simon Francis ThomsenAarhus University HospitalRecruitingChronic Spontaneous Urticaria | Chronic Urticaria, IdiopathicDenmark
-
Yuhan CorporationRecruitingAllergic Disease | Chronic Spontaneous Urticaria | Cold Urticaria | Chronic Inducible UrticariaKorea, Republic of
Clinical Trials on TEV-45779
-
Teva Branded Pharmaceutical Products R&D, Inc.Terminated
-
Verigraft ABRecruitingChronic Venous InsufficiencySpain
-
Teva Branded Pharmaceutical Products R&D, Inc.RecruitingCrohn Disease | Colitis, UlcerativeUnited States, Hungary, Poland, Czechia, Japan, Belgium, Spain, Bulgaria, France, Italy, Slovakia, Austria
-
Teva Branded Pharmaceutical Products R&D, Inc.TerminatedCluster HeadacheUnited States, Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
-
Teva Branded Pharmaceutical Products R&D, Inc.TerminatedAsthmaUnited States, Bulgaria, Czechia, Germany, Poland
-
Teva Branded Pharmaceutical Products R&D, Inc.WithdrawnType 2 Diabetes Mellitus | Nonalcoholic Steatohepatitis
-
Teva Branded Pharmaceutical Products R&D, Inc.TerminatedChronic Cluster HeadacheUnited States, Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedMigraineUnited States, Canada, Czechia, Finland, Israel, Japan, Poland, Russian Federation, Spain
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedPost-Traumatic HeadacheUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.TerminatedEpisodic Cluster HeadacheUnited States, Australia, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, Canada