Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Arm 1: Dose :Usnoflast 50 mg + placebo 25 mg
Route : Oral
Duration : 12 week
Intervention2: Arm 2: Dose :Usnoflast 50 mg + Usnoflast 25 mg
Route : Oral
Duration : 12 week
Control Interv
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and female participants aged 18 to 75 years, both inclusive. 2) 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. 3) 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 1. 4) 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. 5)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. 6)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.
Exclusion criteria
Exclusion criteria: 1)Diagnosis of Crohn s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn s disease. 2) Have positive test for C. difficile at screening. If C. difficile is positive, the participant may be treated and retested. 3) Participants who have an evidence of pathogenic bowel infection on screening at inves-tigator s discretion. 4) History of recurrent or chronic infection (e.g., hepatitis B or C, syphilis, TB). 5) 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. 7) 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. 9) 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. 10) History of treatment with an investigational agent within 5 half-lives of that agent prior to randomization. 11) History of treatment with rectal steroids within 2 weeks of screening. 12) Receipt of a live vaccine within 4 weeks prior to randomization. 13) 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. 15) Pregnant or lactating women or women of childbearing potential who have positive serum beta HCG test at screening. 16) 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). 17) Participants who have participated in any drug research study other than the present trial within past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving clinical responseTimepoint: Week 12 and Week 24;Proportion of participants in clinical remissionTimepoint: Week 24;Proportion of participants in endoscopic remissionTimepoint: Week 12 and Week 24;Proportion of participant requiring rescue therapy (Steroid/biological agent) during the trialTimepoint: Baseline to EOT;Mean change in biomarker fecal calprotectinTimepoint: 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 abnormalitiesTimepoint: Baseline to EOT | — |
Countries
India
Contacts
Public ContactDr Suchi Shah
Zydus Lifesciences Ltd
Outcome results
None listed