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

Primary Purpose

Chronic Urticaria

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TEV-45779
XOLAIR® Injection
Sponsored by
Teva Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Urticaria

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 10008
  • Site 10001
  • 10012
  • 10006
  • 10014
  • 10005
  • 10009
  • 10007
  • 10004

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

TEV-45779-300 mg Main Treatment period

Xolair-300 mg Main Treatment Period

TEV-45779-150 mg Main Treatment period

Xolair-150 mg Main Treatment Period

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

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

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

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

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

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

Arm Description

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

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

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

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

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) 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 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) 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) 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 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.

Outcomes

Primary Outcome Measures

Change from baseline in the ISS7 at Week 12 between TEV 45779 300 mg and XOLAIR 300 mg
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).
Relative potency of TEV 45779 and XOLAIR
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.

Secondary Outcome Measures

Change from baseline in the ISS7 at 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).
Change from baseline in the UAS7 at 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.
Percentage of patients with a UAS7 ≤6 at Week 12
Percentage of patients with a weekly Urticaria Activity Score ≤6 at Week 12
Percentage of complete responders (UAS7=0) at Week 12
Percentage of complete responders with weekly Urticaria Activity Score =0 at Week 12
Change from baseline in the physician's (in-clinic) assessment of UAS7 at Week 12
Change from baseline in the physician's (in-clinic) assessment of weekly Urticaria Activity Score at Week 12.
Change from baseline in the weekly number of wheals score at Week 12
Change from baseline in the weekly number of wheals score at Week 12
Change from baseline in the weekly size of the largest wheals score at Week 12
Change from baseline in the weekly size of the largest wheals score at Week 12
Time to MID response in ISS7 score by 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
Percentage of ISS7 MID responders at Week 12
Percentage of patients with minimally important difference defined as reduction of ≥5 points from baseline in ISS7 at Week 12.
Percentage of angioedema-free days from Week 4 to Week 12
Percentage of angioedema-free days from Week 4 to Week 12
Change from baseline in the overall DLQI score at 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
Change from Week 12 in ISS7 at Week 24
Change from Week 12 in ISS7 at Week 24
Change from Week 12 in ISS7 at Week 40
Change from Week 12 in ISS7 at Week 40.
Change from Week 12 in the UAS7 at 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.
Change from Week 12 in the physician's (in-clinic) assessment of UAS7 at Week 24
Change from Week 12 in the physician's (in-clinic) assessment of UAS7 at Week 24
Change from Week 12 in the weekly number of wheals score at Week 24
Change from Week 12 in the weekly number of wheals score at Week 24.
Change from Week 12 in the weekly number of wheals score at Week 40
Change from Week 12 in the weekly number of wheals score at Week 40.
Change from Week 12 in the weekly number of the largest wheals score at Week 24
Change from Week 12 in the weekly number of the largest wheals score at Week 24.
Change from Week 12 in the weekly number of the largest wheals score at Week 40
Change from Week 12 in the weekly number of the largest wheals score at Week 40.
Percentage of angioedema-free days from Week 12 to Week 24
Percentage of angioedema-free days from Week 12 to Week 24
Change from Week 12 in the overall DLQI score at Week 24
Change from Week 12 in the overall dermatology life quality index (DLQI) score at Week 24
Change from Week 12 in the overall DLQI score at Week 40
Change from Week 12 in the overall dermatology life quality index (DLQI) score at Week 40
Incidence of adverse event and withdrawals due to adverse events in the main period
Number of patients reporting at least one treatment-emergent adverse event up to week 12
Incidence of adverse event in the transition and follow up period
Number of patients reporting at least one treatment-emergent adverse event from week 12 till week 40
Incidence of antidrug antibodies (ADAs) in the main treatment period
Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline up to week 12
Incidence of antidrug antibodies (ADAs) in the transition and follow up period
Number of patients with confirmed positive antidrug antibodies (ADAs) post-week 12 up to week 40

Full Information

First Posted
July 14, 2021
Last Updated
June 21, 2023
Sponsor
Teva Pharmaceuticals USA
Collaborators
Teva Pharmaceuticals Development, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04976192
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Pharmaceuticals USA
Collaborators
Teva Pharmaceuticals Development, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEV-45779-300 mg Main Treatment period
Arm Type
Experimental
Arm Description
TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8
Arm Title
Xolair-300 mg Main Treatment Period
Arm Type
Active Comparator
Arm Description
XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8
Arm Title
TEV-45779-150 mg Main Treatment period
Arm Type
Experimental
Arm Description
TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8
Arm Title
Xolair-150 mg Main Treatment Period
Arm Type
Active Comparator
Arm Description
XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8
Arm Title
TEV-45779-300 mg Main / TEV45779-300 mg Transition Period
Arm Type
Experimental
Arm 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.
Arm Title
Xolair-300 mg Main / TEV45779-300 mg Transition Period
Arm Type
Experimental
Arm 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.
Arm Title
Xolair-300 mg Main / Xolair-300 mg Transition Period
Arm Type
Active Comparator
Arm 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.
Arm Title
TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period
Arm Type
Experimental
Arm 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.
Arm Title
Xolair-150 mg Main / TEV-45779-150 mg Transition Period
Arm Type
Experimental
Arm 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.
Arm Title
Xolair-150 mg Main / Xolair-150 mg Transition Period
Arm Type
Active Comparator
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
TEV-45779
Intervention Description
TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
Intervention Type
Combination Product
Intervention Name(s)
XOLAIR® Injection
Intervention Description
XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.
Primary Outcome Measure Information:
Title
Change from baseline in the ISS7 at Week 12 between TEV 45779 300 mg and XOLAIR 300 mg
Description
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).
Time Frame
Baseline and week 12
Title
Relative potency of TEV 45779 and XOLAIR
Description
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.
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Change from baseline in the ISS7 at Week 12
Description
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).
Time Frame
Baseline, week 4 and week 12
Title
Change from baseline in the UAS7 at Week 12
Description
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.
Time Frame
Baseline and week 12
Title
Percentage of patients with a UAS7 ≤6 at Week 12
Description
Percentage of patients with a weekly Urticaria Activity Score ≤6 at Week 12
Time Frame
week 12
Title
Percentage of complete responders (UAS7=0) at Week 12
Description
Percentage of complete responders with weekly Urticaria Activity Score =0 at Week 12
Time Frame
week 12
Title
Change from baseline in the physician's (in-clinic) assessment of UAS7 at Week 12
Description
Change from baseline in the physician's (in-clinic) assessment of weekly Urticaria Activity Score at Week 12.
Time Frame
Baseline and week 12
Title
Change from baseline in the weekly number of wheals score at Week 12
Description
Change from baseline in the weekly number of wheals score at Week 12
Time Frame
Baseline and week 12
Title
Change from baseline in the weekly size of the largest wheals score at Week 12
Description
Change from baseline in the weekly size of the largest wheals score at Week 12
Time Frame
Baseline and week 12
Title
Time to MID response in ISS7 score by Week 12
Description
Time to minimally important difference (MID) defined as a reduction from baseline in ISS7 of ≥5 points) response in ISS7 score by Week 12
Time Frame
Baseline till week 12
Title
Percentage of ISS7 MID responders at Week 12
Description
Percentage of patients with minimally important difference defined as reduction of ≥5 points from baseline in ISS7 at Week 12.
Time Frame
Baseline and week 12
Title
Percentage of angioedema-free days from Week 4 to Week 12
Description
Percentage of angioedema-free days from Week 4 to Week 12
Time Frame
week 4 and week 12
Title
Change from baseline in the overall DLQI score at Week 12
Description
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
Time Frame
Baseline and week 12
Title
Change from Week 12 in ISS7 at Week 24
Description
Change from Week 12 in ISS7 at Week 24
Time Frame
week 12 and week 24
Title
Change from Week 12 in ISS7 at Week 40
Description
Change from Week 12 in ISS7 at Week 40.
Time Frame
week 12 and week 40
Title
Change from Week 12 in the UAS7 at Week 24
Description
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.
Time Frame
week 12 and week 24
Title
Change from Week 12 in the physician's (in-clinic) assessment of UAS7 at Week 24
Description
Change from Week 12 in the physician's (in-clinic) assessment of UAS7 at Week 24
Time Frame
week 12 and week 24
Title
Change from Week 12 in the weekly number of wheals score at Week 24
Description
Change from Week 12 in the weekly number of wheals score at Week 24.
Time Frame
week 12 and week 24
Title
Change from Week 12 in the weekly number of wheals score at Week 40
Description
Change from Week 12 in the weekly number of wheals score at Week 40.
Time Frame
week 12 and week 40
Title
Change from Week 12 in the weekly number of the largest wheals score at Week 24
Description
Change from Week 12 in the weekly number of the largest wheals score at Week 24.
Time Frame
week 12 and week 24
Title
Change from Week 12 in the weekly number of the largest wheals score at Week 40
Description
Change from Week 12 in the weekly number of the largest wheals score at Week 40.
Time Frame
week 12 and week 40
Title
Percentage of angioedema-free days from Week 12 to Week 24
Description
Percentage of angioedema-free days from Week 12 to Week 24
Time Frame
week 12 and week 24
Title
Change from Week 12 in the overall DLQI score at Week 24
Description
Change from Week 12 in the overall dermatology life quality index (DLQI) score at Week 24
Time Frame
week 12 and week 24
Title
Change from Week 12 in the overall DLQI score at Week 40
Description
Change from Week 12 in the overall dermatology life quality index (DLQI) score at Week 40
Time Frame
week 12 and week 40
Title
Incidence of adverse event and withdrawals due to adverse events in the main period
Description
Number of patients reporting at least one treatment-emergent adverse event up to week 12
Time Frame
Baseline till week 12
Title
Incidence of adverse event in the transition and follow up period
Description
Number of patients reporting at least one treatment-emergent adverse event from week 12 till week 40
Time Frame
week 12 till week 40
Title
Incidence of antidrug antibodies (ADAs) in the main treatment period
Description
Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline up to week 12
Time Frame
Baseline till week 12
Title
Incidence of antidrug antibodies (ADAs) in the transition and follow up period
Description
Number of patients with confirmed positive antidrug antibodies (ADAs) post-week 12 up to week 40
Time Frame
week 12 till week 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Pharmaceuticals Development, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
10008
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Site 10001
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
10012
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
10006
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
Country
United States
Facility Name
10014
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
10005
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
10009
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
10007
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
10004
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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