A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

Genentech

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: MTPS9579A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129423

GA43512

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 8 patient groups, including a placebo group

Part 1: MTPS9579A Dose A

Experimental group

Description:

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

Treatment:

Drug: MTPS9579A

Part 1: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Part 2: MTPS9579A Dose A

Experimental group

Description:

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

Treatment:

Drug: MTPS9579A

Part 2: MTPS9579A Dose B

Experimental group

Description:

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

Treatment:

Drug: MTPS9579A

Part 2: MTPS9579A Dose C

Experimental group

Description:

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

Treatment:

Drug: MTPS9579A

Part 2: MTPS9579A Dose D

Experimental group

Description:

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

Treatment:

Drug: MTPS9579A

Part 2: Placebo Dose A

Placebo Comparator group

Description:

In Part 2, participants will receive placebo matched with MTPS9579A dose A and B, every 4 weeks from randomization through Week 12.

Treatment:

Drug: Placebo

Part 2: Placebo Dose B

Placebo Comparator group

Description:

In Part 2, participants will receive placebo matched with MTPS9579A dose C and D, every 4 weeks from randomization through Week 12.

Treatment:

Drug: Placebo