A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
Key facts
- Who runs it
- Genentech, Inc.
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- 31 Jul 2022
- Ended
- 31 Aug 2024
- Type of study
- Interventional, 8 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- MTPS9579A
- Placebo
- Record updated
- 18 November 2022
- Why it stopped
- Development of MTPS9579A was terminated for strategic/business reasons.
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous participation in a clinical trial of MTPS9579A
- Uncontrolled disease where flares are commonly treated with systemic corticosteroids
- Chronic urticaria with known cause or other disease with symptoms of urticaria or angioedema
- Other skin disease associated with chronic itching
- History of anaphylaxis without clearly identifiable avoidable antigen
- History of anaphylaxis to any biologic therapy for any indication
- 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
About the trial
What the trial wants to find out
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.
The 8 groups in the trial
- Part 1: MTPS9579A Dose ATreatment being tested
In Part 1, participants will receive MTPS9579A dose A every 4 weeks from randomization to Week 12.
Treatment: MTPS9579A
- Part 1: PlaceboPlacebo, for comparison
In Part 1, participants will receive placebo matched with MTPS9579A, every 4 weeks from randomization through Week 12.
Treatment: Placebo
- Part 2: MTPS9579A Dose ATreatment being tested
In Part 2, participants will receive MTPS9579A dose A, every 4 weeks from randomization to Week 12.
Treatment: MTPS9579A
- Part 2: MTPS9579A Dose BTreatment being tested
In Part 2, participants will receive MTPS9579A dose B, every 4 weeks from randomization to Week 12.
Treatment: MTPS9579A
- Part 2: MTPS9579A Dose CTreatment being tested
In Part 2, participants will receive MTPS9579A dose C, every 4 weeks from randomization to Week 12.
Treatment: MTPS9579A
- Part 2: MTPS9579A Dose DTreatment being tested
In Part 2, participants will receive MTPS9579A dose D, every 4 weeks from randomization to Week 12.
Treatment: MTPS9579A
- Part 2: Placebo Dose APlacebo, for comparison
In Part 2, participants will receive placebo matched with MTPS9579A dose A and B, every 4 weeks from randomization through Week 12.
Treatment: Placebo
- Part 2: Placebo Dose BPlacebo, for comparison
In Part 2, participants will receive placebo matched with MTPS9579A dose C and D, every 4 weeks from randomization through Week 12.
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
- Record updated
- 18 November 2022