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Monoclonal Antibodies
Part 2: MTPS9579A Dose D for Chronic Urticaria
Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 96 weeks
Awards & highlights
Study Summary
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.
Eligible Conditions
- Chronic Urticaria
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in the UAS7
Secondary outcome measures
Incidence of ADAs
Percentage of Participants With Adverse Events
Prevalence of Anti-Drug Antibodies (ADAs)
+3 moreSide effects data
From 2022 Phase 2 trial • 135 Patients • NCT0409258228%
Asthma
9%
COVID-19
7%
Headache
6%
Nasopharyngitis
4%
Arthralgia
1%
Clavicle fracture
1%
Dermatitis
1%
Abortion spontaneous
1%
Accidental death
1%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
MTPS9579A, 1800 mg
Placebo
Trial Design
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: MTPS9579A Dose DExperimental Treatment1 Intervention
In Part 2, participants will receive MTPS9579A dose D, every 4 weeks from randomization to Week 12.
Group II: Part 2: MTPS9579A Dose CExperimental Treatment1 Intervention
In Part 2, participants will receive MTPS9579A dose C, every 4 weeks from randomization to Week 12.
Group III: Part 2: MTPS9579A Dose BExperimental Treatment1 Intervention
In Part 2, participants will receive MTPS9579A dose B, every 4 weeks from randomization to Week 12.
Group IV: Part 2: MTPS9579A Dose AExperimental Treatment1 Intervention
In Part 2, participants will receive MTPS9579A dose A, every 4 weeks from randomization to Week 12.
Group V: Part 1: MTPS9579A Dose AExperimental Treatment1 Intervention
In Part 1, participants will receive MTPS9579A dose A every 4 weeks from randomization to Week 12.
Group VI: Part 1: PlaceboPlacebo Group1 Intervention
In Part 1, participants will receive placebo matched with MTPS9579A, every 4 weeks from randomization through Week 12.
Group VII: Part 2: Placebo Dose APlacebo Group1 Intervention
In Part 2, participants will receive placebo matched with MTPS9579A dose A and B, every 4 weeks from randomization through Week 12.
Group VIII: Part 2: Placebo Dose BPlacebo Group1 Intervention
In Part 2, participants will receive placebo matched with MTPS9579A dose C and D, every 4 weeks from randomization through Week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MTPS9579A
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,689 Total Patients Enrolled
10 Trials studying Chronic Urticaria
1,484 Patients Enrolled for Chronic Urticaria
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,502 Total Patients Enrolled
4 Trials studying Chronic Urticaria
690 Patients Enrolled for Chronic Urticaria
Frequently Asked Questions
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