A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

NCT05129423 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: GA43512
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of Participants With Well-Controlled Urticaria

  Week 12

• Proportion of Participants Who Achieve Complete Response

  Week 12

• Percentage of Participants With Adverse Events

  Up to approximately 96 weeks

• Serum Concentration of MTPS9579A

  Through Week 20

• Prevalence of Anti-Drug Antibodies (ADAs)

  Through Week 20

Study Arms (8)

Part 1: MTPS9579A Dose A

EXPERIMENTAL

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

Drug: MTPS9579A

Part 1: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 2: MTPS9579A Dose A

EXPERIMENTAL

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

Drug: MTPS9579A

Part 2: MTPS9579A Dose B

EXPERIMENTAL

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

Drug: MTPS9579A

Part 2: MTPS9579A Dose C

EXPERIMENTAL

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

Drug: MTPS9579A

Part 2: MTPS9579A Dose D

EXPERIMENTAL

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

Drug: MTPS9579A

Part 2: Placebo Dose A

PLACEBO COMPARATOR

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

Drug: Placebo

Part 2: Placebo Dose B

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MTPS9579A DRUG

MTPS9579A will be administered.

Part 1: MTPS9579A Dose A; Part 2: MTPS9579A Dose A; Part 2: MTPS9579A Dose B; Part 2: MTPS9579A Dose C; Part 2: MTPS9579A Dose D

Placebo DRUG

Placebo matched with MTPS9579A will be administered.

Part 1: Placebo; Part 2: Placebo Dose A; Part 2: Placebo Dose B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 22, 2021
• Study Start: July 31, 2022
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share