A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

Last updated: November 16, 2022
Sponsor: Genentech, Inc.
Overall Status: Trial Not Available

Phase

2

Condition

Urticaria

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT05129423
GA43512
  • Ages 18-75
  • All Genders

Study 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

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 ofthe study
  • For patients on H2 antihistamines or LTRAs for non-CSU indications, treatment at astable dose for >=2 weeks prior to screening, with no anticipated changes throughoutduration of study, including the screening period
  • For women of childbearing potential: agreement to remain abstinent or usecontraception
  • For men: agreement to remain abstinent or use a condom, and agreement to refrain fromdonating sperm

Exclusion

Exclusion Criteria:

  • Previous participation in a clinical trial of MTPS9579A
  • Chronic urticaria with known cause or other disease with symptoms of urticaria orangioedema
  • 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 orabnormalities in laboratory tests that, in the investigator's judgment, preclude thepatient's safe participation and completion of the study, or interferes with theconduct and interpretation of the study
  • History of anaphylaxis without clearly identifiable avoidable antigen
  • History of anaphylaxis to any biologic therapy for any indication

Study Design

Study Start date:
July 31, 2022
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Clinical Research Center of Alabama, LLC

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • NewportNativeMD,Inc

    Newport Beach, California 92663
    United States

    Site Not Available

  • California Allergy & Asthma Medical Group, Inc.

    Palmdale, California 93551
    United States

    Site Not Available

  • Florida Ctr-Allergy & Asthma

    Miami, Florida 33173
    United States

    Site Not Available

  • Florida Pulmonary Research Institute, LLC

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73012
    United States

    Site Not Available

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