EUCTR2019-001430-33-FR进行中（未招募）1 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- 性别
- All
入选标准
- •1) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- •2) Males, or non-pregnant, non-lactating females, at least 18 years of age based on the date of the screening visit.
- •3) UC of at least 3 months duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.
- •4) Moderately to severely active UC as determined during screening by a centrally read endoscopy score = 2, a Rectal Bleeding subscore = 1, a Stool Frequency subscore = 1 and Physicians Global Assessment (PGA) of = 2 as defined by the Mayo Clinic Score; total MCS must be between 6 and 12, inclusive.
- •5) Previously demonstrated an inadequate response (primary non-response) or loss of response (secondary non-response) to a TNFa inhibitor (ie, infliximab, adalimumab, golimumab, or biosimilars).
- •6) May be receiving concomitant therapy for UC at the time of enrollment.
- •7) A surveillance colonoscopy is required prior to screening in subjects with a history of UC for 8 or more years, if one was not performed in the prior 24 months.
- •8) Meet the Tuberculosis (TB) screening criteria.
- •9) Laboratory assessments at screening within the defined parameters.
- •10) Stool sample test result negative for enteric pathogens
- •11) Stool sample test result negative for ova and parasites (O&P) unless approved by the medical monitor.
- •12) Negative HIV antibody test.
- •13) Negative HBV surface antigen test. Subjects with negative HBsAg test and positive HBV core antibody (HBcAb) test must have a HBV DNA < LLOQ.
- •14) Negative HCV antibody test or HCV RNA < LLOQ.
- •15) Negative urine drug screen result. A positive drug screen will exclude subjects unless it can be explained by the use of a medication (prescription or nonprescription) that is being used under the direction of a physician. Cocaine use is exclusionary.
- •16) Females of childbearing potential must have a negative pregnancy test result at screening and Day 1 prior to randomization.
- •17) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must be willing to use protocol specified method(s) of contraception.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •1) Currently displaying clinical signs of acute severe colitis, fulminant colitis, or toxic megacolon.
- •2) Prior surgery for UC.
- •3) Subjects who are likely to require any type of major surgery during the study. Cataract surgery, breast surgery without reconstruction, laparoscopic cholecystectomy, laparoscopic tubal ligation and most cutaneous, superficial, endoscopic and arthroscopic procedures can be considered minor surgeries.
- •4) Have had any major surgery or trauma within 8 weeks prior to randomization.
- •5) History or evidence of incompletely resected colonic mucosal dysplasia.
- •6) History of malignancy in the last 5 years except for subjects who have been treated or resected for either non-melanoma skin cancer or cervical carcinoma in situ.
- •7) History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma.
- •8) Any chronic medical condition (including, but not limited to cardiac or pulmonary disease) or psychiatric problem (including, but not limited to alcohol or drug abuse) that, in the opinion of the investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol.
- •9) History of immunodeficiency syndrome.
- •10) Have a stoma or ileoanal pouch.
- •11) Dependence on total parenteral nutrition.
- •12) Have a transplanted organ with exception of a corneal transplant.
- •13) Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.
- •14) History of opportunistic infection.
- •15) History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system zoster.
- •16) Currently on any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
- •17) Use of prohibited concomitant medications.
- •18) Administration of a live or attenuated vaccine within 4 weeks of randomization
- •19) Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and up to 37 days after last dose of the study drug.
- •20) Male subjects unwilling to refrain from sperm donation for at least 90 days after last dose of the study drug.
- •21) Known hypersensitivity to GS-4875, its metabolites, or formulation excipients.
研究者
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