A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).

NCT ID: NCT03137069

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-26
• Study Completion Date: 2019-10-25

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria (CSU) already treated with anti-histamines. Participants have the option to enter the Open-Label Extension (OLE) study after completing the 8-week treatment period.

Conditions

Urticaria

Study Design

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

Study Groups

Cohort 1: Placebo

Participants received matching placebo twice daily from Day 1 to 56.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo will be administered orally, as per the dosing schedules described above.

Cohort 1: GDC-0853 200mg BID

Participants received GDC-0853 200mg twice daily from Day 1 to 56.

Group Type: EXPERIMENTAL

GDC-0853

Intervention Type: DRUG

GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.

Cohort 2: Placebo

Participants received matching placebo up to twice daily from Day 1 to 56.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo will be administered orally, as per the dosing schedules described above.

Cohort 2: GDC-0853 50mg QD

Participants received GDC-0853 50mg once daily from Day 1 to 56.

Group Type: EXPERIMENTAL

GDC-0853

Intervention Type: DRUG

GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.

Cohort 2: GDC-0853 150mg QD

Participants received GDC-0853 150mg once daily from Day 1 to 56.

Group Type: EXPERIMENTAL

GDC-0853

Intervention Type: DRUG

GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.

Cohort 2: GDC-0853 200mg BID

Participants received GDC-0853 200mg twice daily from Day 1 to 56.

Group Type: EXPERIMENTAL

GDC-0853

Intervention Type: DRUG

GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.

Interventions

GDC-0853

GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.

Intervention Type: DRUG

Placebo

Matching Placebo will be administered orally, as per the dosing schedules described above.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18-75 years, inclusive
• Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1 antihistamines at the time of randomization
• Willing and able to complete an Urticaria Participant Daily eDiary for the duration of the study
• No evidence of active or latent or inadequately treated infection with tuberculosis (TB)
• Partcipants with a history of Bacille Calmette-Guérin (BCG) vaccination should be screened using the QuantiFERON-TB-Gold (QFT) test
• Only for participants currently receiving proton-pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs): Treatment must be at a stable dose during the 2-week screening period prior to randomization and with a plan to remain at a stable dose for the duration of the study
• For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 4 weeks after the last dose of study drug. Women must refrain from donating eggs during this same period.

Exclusion Criteria

• Treatment with omalizumab or other monoclonal antibody therapies used to treat CSU within 4 months prior to screening or primary nonresponse to omalizumab
• Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to study drug administration on Day 1 (or within 5 half-lives of the investigational product, whichever is greater)
• Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior to study drug administration on Day 1
• Previous treatment with GDC-0853 or other Bruton's tyrosine kinase (BTK) inhibitors
• Participants whose urticaria is solely due to physical urticaria
• Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, or leukemia
• Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or other skin disease associated with itch such as psoriasis
• Routine doses of the following medications within 30 days prior to screening: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
• Prior utilization of intravenous (IV) steroids for treatment of laryngeal angioedema
• Intravenous immunoglobulin G (IV IG) or plasmapheresis within 30 days prior to screening
• History of anaphylactic shock without clearly identifiable avoidable antigen
• Hypersensitivity to GDC-0853 or any component of the formulation
• Major surgery within 8 weeks prior to screening or surgery planned prior to end of study (12 weeks after randomization)
• Require any prohibited concomitant medications
• History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during study drug treatment
• Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal (GI) disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participant participation
• Current treatment with astemizole, terfenadine, and/or ebastine
• Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids

• 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

Locations

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

Allergy & Asthma Immunology Associates

Scottsdale, Arizona, United States

Kern Allergy Med Clinic, Inc.

Bakersfield, California, United States

Southern California Research Center

Mission Viejo, California, United States

Allergy & Asthma Consultants

Redwood City, California, United States

Integrated Research Group Inc

Riverside, California, United States

Integrated Research of Inland

Upland, California, United States

New Horizon Research Center

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Vital Prospects Clinical Research Institute PC - CRN

Tulsa, Oklahoma, United States

Asthma, Nasal Disease, and Allergy Research Center of New England

East Providence, Rhode Island, United States

Center for Clinical Studies

Cypress, Texas, United States

Timber Lane Allergy and Asthma Research, LLC

Burlington, Vermont, United States

University of British Columbia

Vancouver, British Columbia, Canada

Private Practice - Dr. Jason Ohayon

Hamilton, Ontario, Canada

Lynde Institute for Dermatology

Markham, Ontario, Canada

Cheema Research

Mississauga, Ontario, Canada

Yang Medicine

Ottawa, Ontario, Canada

Gordon Sussman Clinical Research

Toronto, Ontario, Canada

Private Practice - Dr. Isabelle Delorme

Drummondville, Quebec, Canada

Centre de Recherche Applique En Allergie de Quebec

Québec, Quebec, Canada

Licca Clinical Research Institute

Augsburg, , Germany

Charite Mitte; Klinik fur Dermatologie

Berlin, , Germany

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

Dresden, , Germany

Hautarztpraxis Mahlow

Mahlow, , Germany

Universitätsmedizin Johannes Gutenberg Universität

Mainz, , Germany

Klinik für Haut- und Geschlechtskrankheiten, Universitätsklinikum Münster

Münster, , Germany

Countries

United States; Canada; Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-004624-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS39684

Identifier Type: -

Identifier Source: org_study_id