A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

Chronic Spontaneous Urticaria Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05129423
• Other study ID #: GA43512
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 31, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2022
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Drug:
• MTPS9579A
MTPS9579A will be administered.
• Placebo
Placebo matched with MTPS9579A will be administered.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the UAS7	Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12.	Week 12
Secondary	Proportion of Participants With Well-Controlled Urticaria	Proportion of participants with well-controlled urticaria (UAS7<=6) at Week 12.	Week 12
Secondary	Proportion of Participants Who Achieve Complete Response	Proportion of participants who achieve complete response (UAS7=0) at Week 12.	Week 12
Secondary	Percentage of Participants With Adverse Events	Percentage of participants with adverse events.	Up to approximately 96 weeks
Secondary	Serum Concentration of MTPS9579A		Through Week 20
Secondary	Prevalence of Anti-Drug Antibodies (ADAs)		Through Week 20
Secondary	Incidence of ADAs		Through Week 20