A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
November 16, 2022 updated by: Genentech, Inc.
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines.
This study comprises two parts.
In Part 1, participants will be randomized to receive MTPS9579A or placebo.
On the basis of positive results from Part 1, a dose-ranging Part 2 may be opened, where participants will be randomized to receive one of four MTPS9579A doses or placebo.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of CSU refractory to sgH1-AHs at the time of randomization
- Demonstrated ability to comply with the required use of the eDiary for the duration of the study
- For patients on H2 antihistamines or LTRAs for non-CSU indications, treatment at a stable dose for >=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period
- For women of childbearing potential: agreement to remain abstinent or use contraception
- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
Exclusion Criteria:
- Previous participation in a clinical trial of MTPS9579A
- Chronic urticaria with known cause or other disease with symptoms of urticaria or angioedema
- Other skin disease associated with chronic itching
- Uncontrolled disease where flares are commonly treated with systemic corticosteroids
- History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, preclude the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study
- History of anaphylaxis without clearly identifiable avoidable antigen
- History of anaphylaxis to any biologic therapy for any indication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Part 1: MTPS9579A Dose A
In Part 1, participants will receive MTPS9579A dose A every 4 weeks from randomization to Week 12.
|
MTPS9579A will be administered.
|
|
PLACEBO_COMPARATOR: Part 1: Placebo
In Part 1, participants will receive placebo matched with MTPS9579A, every 4 weeks from randomization through Week 12.
|
Placebo matched with MTPS9579A will be administered.
|
|
EXPERIMENTAL: Part 2: MTPS9579A Dose A
In Part 2, participants will receive MTPS9579A dose A, every 4 weeks from randomization to Week 12.
|
MTPS9579A will be administered.
|
|
EXPERIMENTAL: Part 2: MTPS9579A Dose B
In Part 2, participants will receive MTPS9579A dose B, every 4 weeks from randomization to Week 12.
|
MTPS9579A will be administered.
|
|
EXPERIMENTAL: Part 2: MTPS9579A Dose C
In Part 2, participants will receive MTPS9579A dose C, every 4 weeks from randomization to Week 12.
|
MTPS9579A will be administered.
|
|
EXPERIMENTAL: Part 2: MTPS9579A Dose D
In Part 2, participants will receive MTPS9579A dose D, every 4 weeks from randomization to Week 12.
|
MTPS9579A will be administered.
|
|
PLACEBO_COMPARATOR: Part 2: Placebo Dose A
In Part 2, participants will receive placebo matched with MTPS9579A dose A and B, every 4 weeks from randomization through Week 12.
|
Placebo matched with MTPS9579A will be administered.
|
|
PLACEBO_COMPARATOR: Part 2: Placebo Dose B
In Part 2, participants will receive placebo matched with MTPS9579A dose C and D, every 4 weeks from randomization through Week 12.
|
Placebo matched with MTPS9579A will be administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in the UAS7
Time Frame: Week 12
|
Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants With Well-Controlled Urticaria
Time Frame: Week 12
|
Proportion of participants with well-controlled urticaria (UAS7<=6) at Week 12.
|
Week 12
|
|
Proportion of Participants Who Achieve Complete Response
Time Frame: Week 12
|
Proportion of participants who achieve complete response (UAS7=0) at Week 12.
|
Week 12
|
|
Percentage of Participants With Adverse Events
Time Frame: Up to approximately 96 weeks
|
Percentage of participants with adverse events.
|
Up to approximately 96 weeks
|
|
Serum Concentration of MTPS9579A
Time Frame: Through Week 20
|
Through Week 20
|
|
|
Prevalence of Anti-Drug Antibodies (ADAs)
Time Frame: Through Week 20
|
Through Week 20
|
|
|
Incidence of ADAs
Time Frame: Through Week 20
|
Through Week 20
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 31, 2022
Primary Completion (ANTICIPATED)
July 31, 2024
Study Completion (ANTICIPATED)
August 31, 2024
Study Registration Dates
First Submitted
November 5, 2021
First Submitted That Met QC Criteria
November 10, 2021
First Posted (ACTUAL)
November 22, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 18, 2022
Last Update Submitted That Met QC Criteria
November 16, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA43512
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com).
Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx).
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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.