A Study of GDC-0853 in Patients With Chronic Spontaneous Urticaria Refractory to Anti-histamines
- Conditions
- 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 disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2016-004624-35-DE
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 165
- 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 < 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.
-For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm for at least 4 weeks after the last dose of study treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of fenebrutinib compared with placebo in patients with CSU who are refractory to anti-histamines;<br> Secondary Objective: •To evaluate the safety of fenebrutinib compared with placebo<br> •To characterize the pharmacokinetics (PK) of fenebrutinib in CSU patients<br> ;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 Outcome Measures
Name Time Method <br> Secondary end point(s): 1.Proportion of patients who are well controlled (UAS7 <= 6) at Day 57<br> 2.Change from baseline in the UAS7 at Day 29 (Week 4)<br> 3.The nature, frequency, timing, and severity of adverse events<br> 4.Change from baseline in targeted vital signs, physical examination findings, ECGs, and clinical laboratory results following fenebrutinib administration<br> 5.Plasma concentrations of fenebrutinib at specified timepoints<br> ;<br> Timepoint(s) of evaluation of this end point: 1.Day 57 (Week 8)<br> 2.Baseline and Day 29 (Week 4)<br> 3.Up to 14 weeks<br> 4.From Baseline to 14 weeks<br> 5-10.Day 1 (Week 0), Day 8 (Week 1), Day 57 (Week 8) or at early termination<br>