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A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

Primary Purpose

Chronic Spontaneous Urticaria

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MTPS9579A
Placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Part 1: MTPS9579A Dose A

    Part 1: Placebo

    Part 2: MTPS9579A Dose A

    Part 2: MTPS9579A Dose B

    Part 2: MTPS9579A Dose C

    Part 2: MTPS9579A Dose D

    Part 2: Placebo Dose A

    Part 2: Placebo Dose B

    Arm Description

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

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

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

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

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Change From Baseline in the UAS7
    Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12.

    Secondary Outcome Measures

    Proportion of Participants With Well-Controlled Urticaria
    Proportion of participants with well-controlled urticaria (UAS7<=6) at Week 12.
    Proportion of Participants Who Achieve Complete Response
    Proportion of participants who achieve complete response (UAS7=0) at Week 12.
    Percentage of Participants With Adverse Events
    Percentage of participants with adverse events.
    Serum Concentration of MTPS9579A
    Prevalence of Anti-Drug Antibodies (ADAs)
    Incidence of ADAs

    Full Information

    First Posted
    November 5, 2021
    Last Updated
    November 16, 2022
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05129423
    Brief Title
    A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Development of MTPS9579A was terminated for strategic/business reasons.
    Study Start Date
    July 31, 2022 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Spontaneous Urticaria

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1: MTPS9579A Dose A
    Arm Type
    Experimental
    Arm Description
    In Part 1, participants will receive MTPS9579A dose A every 4 weeks from randomization to Week 12.
    Arm Title
    Part 1: Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    In Part 1, participants will receive placebo matched with MTPS9579A, every 4 weeks from randomization through Week 12.
    Arm Title
    Part 2: MTPS9579A Dose A
    Arm Type
    Experimental
    Arm Description
    In Part 2, participants will receive MTPS9579A dose A, every 4 weeks from randomization to Week 12.
    Arm Title
    Part 2: MTPS9579A Dose B
    Arm Type
    Experimental
    Arm Description
    In Part 2, participants will receive MTPS9579A dose B, every 4 weeks from randomization to Week 12.
    Arm Title
    Part 2: MTPS9579A Dose C
    Arm Type
    Experimental
    Arm Description
    In Part 2, participants will receive MTPS9579A dose C, every 4 weeks from randomization to Week 12.
    Arm Title
    Part 2: MTPS9579A Dose D
    Arm Type
    Experimental
    Arm Description
    In Part 2, participants will receive MTPS9579A dose D, every 4 weeks from randomization to Week 12.
    Arm Title
    Part 2: Placebo Dose A
    Arm Type
    Placebo Comparator
    Arm Description
    In Part 2, participants will receive placebo matched with MTPS9579A dose A and B, every 4 weeks from randomization through Week 12.
    Arm Title
    Part 2: Placebo Dose B
    Arm Type
    Placebo Comparator
    Arm Description
    In Part 2, participants will receive placebo matched with MTPS9579A dose C and D, every 4 weeks from randomization through Week 12.
    Intervention Type
    Drug
    Intervention Name(s)
    MTPS9579A
    Intervention Description
    MTPS9579A will be administered.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo matched with MTPS9579A will be administered.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in the UAS7
    Description
    Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12.
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Proportion of Participants With Well-Controlled Urticaria
    Description
    Proportion of participants with well-controlled urticaria (UAS7<=6) at Week 12.
    Time Frame
    Week 12
    Title
    Proportion of Participants Who Achieve Complete Response
    Description
    Proportion of participants who achieve complete response (UAS7=0) at Week 12.
    Time Frame
    Week 12
    Title
    Percentage of Participants With Adverse Events
    Description
    Percentage of participants with adverse events.
    Time Frame
    Up to approximately 96 weeks
    Title
    Serum Concentration of MTPS9579A
    Time Frame
    Through Week 20
    Title
    Prevalence of Anti-Drug Antibodies (ADAs)
    Time Frame
    Through Week 20
    Title
    Incidence of ADAs
    Time Frame
    Through Week 20

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trials
    Organizational Affiliation
    Hoffmann-La Roche
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

    Learn more about this trial

    A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

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