Clinical trial NCT05129423: A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the UAS7
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of Participants With Well-Controlled Urticaria
timeFrame: Week 12
measure: Proportion of Participants Who Achieve Complete Response
timeFrame: Week 12
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 96 weeks
measure: Serum Concentration of MTPS9579A
timeFrame: Through Week 20
measure: Prevalence of Anti-Drug Antibodies (ADAs)
timeFrame: Through Week 20
measure: Incidence of ADAs
timeFrame: Through Week 20
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: