Chronic spontaneous urticaria (CSU) MedDRA version: 20.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: GDC-0853
Product Code: RO701-0939/F13 & RO701-0939/F14
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FENEBRUTINIB
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 18-75 years, inclusive - Diagnosis of CSU refractory to H1 antihistamines at the time of randomization, as defined by all of the following: •The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamines •Urticaria Activity Score over 7 days (UAS7 score)>=16 during the 7 days prior to randomization (Day 1) •Patients must have been on daily stable doses of H1 antihistamines, consistent with standard-of-care therapy for CSU, starting at least 3 consecutive days immediately prior to the screening visit through Day 1 and must document current use on all visits. •CSU diagnosis for >= 6 months -Willing and able to complete an Urticaria Patient Daily eDiary for the duration of the study - Completion of 7 days of the Urticaria Patient Daily eDiary entries in the 7 days prior to randomization - No evidence of active or latent or inadequately treated infection with tuberculosis (TB) - Only for patients currently receiving proton-pump inhibitors or H2 receptor antagonists: 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 or use contraceptive methods that result in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
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 -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 fenebrutinib or other Bruton’s tyrosine kinase inhibitors -Patients whose urticaria is solely due to physical urticaria -Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, urticarial 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 corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide -Prior utilization of intravenous steroids for treatment of laryngeal angioedema -Intravenous immunoglobulin G or plasmapheresis within 30 days prior to screening -History of anaphylactic shock without clearly identifiable avoidable antigen -Hypersensitivity to fenebrutinib or any component of the formulation -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 -Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids -History of vasculitis and opportunistic infections -Current liver disease and any known active infection -History of recurrent bacterial, viral, mycobacterial or fungal infections and any opportunistic infections, with the exception of recurrent oral or genital herpes or uncomplicated urinary tract infections in females -Any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening -Known history of HIV infection -Evidence of chronic and/or active hepatitis B or C -History of cancer, including hematologic malignancy and solid tumors, within 10 years before screening -Need for systemic anti-coagulation with warfarin, other oral or injectable anti-coagulants, or anti-platelet agents other than non-steroidal anti-inflammatory drug, aspirin, and other salicylates -History of non-gallstone-related pancreatitis or chronic pancreatitis a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of fenebrutinib compared with placebo in patients with CSU who are refractory to anti-histamines; Secondary Objective: •To evaluate the safety of fenebrutinib compared with placebo •To characterize the pharmacokinetics (PK) of fenebrutinib in CSU patients ;Primary end point(s): 1.Change from baseline in the UAS7 at Day 57 (Week 8);Timepoint(s) of evaluation of this end point: 1.Baseline and Day 57 (Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Proportion of patients who are well controlled (UAS7 <= 6) at Day 57 2.Change from baseline in the UAS7 at Day 29 (Week 4) 3.The nature, frequency, timing, and severity of adverse events 4.Change from baseline in targeted vital signs, physical examination findings, ECGs, and clinical laboratory results following fenebrutinib administration 5.Plasma concentrations of fenebrutinib at specified timepoints ; Timepoint(s) of evaluation of this end point: 1.Day 57 (Week 8) 2.Baseline and Day 29 (Week 4) 3.Up to 14 weeks 4.From Baseline to 14 weeks 5-10.Day 1 (Week 0), Day 8 (Week 1), Day 57 (Week 8) or at early termination | — |
Countries
Canada, Germany, Poland, Russian Federation, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed