A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

NCT ID: NCT05129423

Last Updated: 2022-11-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2024-08-31

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.

Conditions

Chronic Spontaneous Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1: MTPS9579A Dose A

In Part 1, participants will receive MTPS9579A dose A every 4 weeks from randomization to Week 12.

Group Type: EXPERIMENTAL

MTPS9579A

Intervention Type: DRUG

MTPS9579A will be administered.

Part 1: Placebo

In Part 1, participants will receive placebo matched with MTPS9579A, every 4 weeks from randomization through Week 12.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matched with MTPS9579A will be administered.

Part 2: MTPS9579A Dose A

In Part 2, participants will receive MTPS9579A dose A, every 4 weeks from randomization to Week 12.

Group Type: EXPERIMENTAL

MTPS9579A

Intervention Type: DRUG

MTPS9579A will be administered.

Part 2: MTPS9579A Dose B

In Part 2, participants will receive MTPS9579A dose B, every 4 weeks from randomization to Week 12.

Group Type: EXPERIMENTAL

MTPS9579A

Intervention Type: DRUG

MTPS9579A will be administered.

Part 2: MTPS9579A Dose C

In Part 2, participants will receive MTPS9579A dose C, every 4 weeks from randomization to Week 12.

Group Type: EXPERIMENTAL

MTPS9579A

Intervention Type: DRUG

MTPS9579A will be administered.

Part 2: MTPS9579A Dose D

In Part 2, participants will receive MTPS9579A dose D, every 4 weeks from randomization to Week 12.

Group Type: EXPERIMENTAL

MTPS9579A

Intervention Type: DRUG

MTPS9579A will be administered.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matched with MTPS9579A will be administered.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matched with MTPS9579A will be administered.

Interventions

MTPS9579A

MTPS9579A will be administered.

Intervention Type: DRUG

Placebo

Placebo matched with MTPS9579A will be administered.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Other Identifiers

GA43512

Identifier Type: -

Identifier Source: org_study_id