A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT AND DOSE-RANGING STUDY OF GDC-0853 IN PATIENTS WITH REFRACTORY CHRONIC SPONTANEOUS URTICARIA (CSU)

Genentech, Inc.0 个研究点目标入组 165 人开始时间: 2017年2月23日最近更新: 2019年12月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Genentech, Inc.
入组人数: 165

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

入选标准

•- 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

排除标准

•-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

研究者

发起方

Genentech, Inc.

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