CTRI/2025/08/092784尚未招募2 期
A study to evaluate the efficacy and safety of Usnoflast oral capsules for the treatment of participants with mild to moderately active Ulcerative Colitis not responding to or intolerant to oral aminosalicylates.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 129
- 试验地点
- 31
- 主要终点
- proportion of participants in clinical remission at Week 12, defined as an mMS score of 0 to 2, including: stool frequency subscore 0 or 1, rectal bleeding subscore 0 and centrally read endoscopy score 0 or 1.
研究概览
简要总结
This is a randomized, double blind, double dummy, parallel, placebo-controlled, phase II clinical trial to evaluate efficacy and safety of Usnoflast oral capsules for the treatment of mild to moderately active ulcerative colitis in participants not responding to or intolerant to oral aminosalicylates.
This trial will be conducted over a period of 29 weeks. Treatment period consist of two periods: induction period of 12 weeks followed by an open label maintenance period of 12 weeks. In this study, eligible participants will be enrolled in either of the following three arms (randomized 1:1:1) for induction period twice daily for 12 weeks.
• Arm 1: 50 mg Usnoflast oral capsule + 25 mg matching placebo
• Arm 2: 50 mg Usnoflast oral capsule + 25 mg Usnoflast oral capsule
• Arm 3: 50 mg matching placebo + 25 mg matching placebo
Subjects will receive any of test regimen [50 mg (Arm 1), 75 mg (Arm 2), matching placebo (Arm 3)] as per randomization schedule for 12 weeks. At the end of 12 weeks, subjects will be assessed for achievement of clinical remission for primary end point assessment..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants aged 18 to 75 years, both inclusive.
- •Have had ulcerative colitis (UC) diagnosed at least 3 months prior to screening.
- •The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
- •Mild to Moderately active disease defined as total score of at least 4 on the mMS, endoscopy subscore of at least 2 and a rectal bleeding sub-score of at least
- •Demonstrated an inadequate response to, loss of response to, or intolerance to any of the Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide) characterized by signs and symptoms of persistently active disease during a current or prior course of at least 4 weeks of treatment with above listed oral aminosalicylates in the opinion of investigator.
- •Women of childbearing potential and men must agree to use adequate birth control measures during the study.
- •Acceptable methods of birth control in this study include sur-gical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-act-ing injectable contraceptive, partner’s vasectomy, double-barrier method (condom or diaphragm with spermicide) or abstinence for at least 4 weeks prior to study drug admin-istration, during study participation and for 30 days after their last dose of study drug.
- •All participants aged 45 years or over must have had a colonoscopy to screen for adenomatous polyps within 5 years of screening or must have had a colonoscopy at screening to assess for polyps.
排除标准
- •Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease.
- •Have positive test for C.
- •difficile at screening.
- •difficile is positive, the participant may be treated and retested.
- •Participants who have an evidence of pathogenic bowel infection on screening at inves-tigator’s discretion.
- •History of recurrent or chronic infection (e.g., hepatitis B or C, syphilis, TB).
- •Laboratory test positive for HBsAg, HCV or HIV at screening 6) Participants who have any known allergy or sensitivity to investigational products or any of its component within 3 months of screening.
- •Participants who have donated blood or blood products within 3 months of screening.
- •Exclusion criteria related to concomitant medication 8) Have had treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 16 weeks prior to screening.
- •History or planned concurrent treatment with biological agents (infliximab, ada-limumab, vedolizumab, and ustekinumab), immunosuppressive agents (e.g., azathio-prine, 6-MP, or methotrexate) or with lymphocyte-depleting therapies (e.g., Campath, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab), Janus kinase (JAK) inhibitor (e.g., Tofacitininb) within 7 days or 5 half-lives of medication (which-ever is longer) prior to randomization and systemic steroids (e.g., prednisolone) before 14 days of randomization.
- •History of treatment with an investigational agent within 5 half-lives of that agent prior to randomization.
- •History of treatment with rectal steroids within 2 weeks of screening.
- •Receipt of a live vaccine within 4 weeks prior to randomization.
- •Chronic use of therapies that strongly inhibit or induce CYP3A4 metabolism within 4 weeks prior to randomization.
- •Exclusion criteria related to general health 14) Clinically relevant cardiovascular, hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by participating in the study.
- •Pregnant or lactating women or women of childbearing potential who have positive serum beta HCG test at screening.
- •History of significant alcoholism or drug abuse within the past 1 year.
- •History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day).
- •Participants who have participated in any drug research study other than the present trial within past 3 months.
结局指标
主要结局
proportion of participants in clinical remission at Week 12, defined as an mMS score of 0 to 2, including: stool frequency subscore 0 or 1, rectal bleeding subscore 0 and centrally read endoscopy score 0 or 1.
时间窗: Baseline to week 12
次要结局
- Proportion of participants achieving clinical response(Week 12 and Week 24)
- Proportion of participants in clinical remission(Week 24)
- Proportion of participants in endoscopic remission(Week 12 and Week 24)
- Proportion of participant requiring rescue therapy (Steroid/biological agent) during the trial(Baseline to EOT)
- Mean change in biomarker fecal calprotectin(Baseline to week 12 & week 24)
- The incidence and type of AEs, SAEs, AEs leading to discontinuation of study treatment, target AEs of spe-cial interest, laboratory abnormalities, vital signs, ECG, and physical examination abnormalities(Baseline to EOT)
研究者
Dr Deven Parmar
Zydus Lifesciences Ltd
研究点 (31)
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