A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE

InDex Pharmaceuticals0 sites440 target enrollmentOctober 25, 2021

ConditionsModerate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856 Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to Severe left-sided Active Ulcerative Colitis
Sponsor: InDex Pharmaceuticals
Enrollment: 440
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 25, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

InDex Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria: Induction
•1\. Male or female \= 18 years of age.
•2\. Established diagnosis of UC, with minimum time from diagnosis of at least 3 months before screening visit 1b.
•3\. Moderate to severe active left\-sided UC (disease should extend 15 cm or more above the anal verge and not beyond the splenic flexure) determined by a 3\-component Mayo score of 5 to 9 with an endoscopic subscore \=2 (in sigmoid or descending segments) assessed by central reading of endoscopy, and with stool frequency and rectal bleeding subscores, assessed by eDiary, each \=1\.
•4\. Have inadequate response, loss of response or be intolerant of at least one of the following treatments:
•a. Oral GCS
•b. AZA/6\-MP
•c. Biologics, JAK\-inhibitors, or other approved advanced therapies for UC
•5\. Allowed to receive a therapeutic dose of the following UC drugs during the study:
•a. Oral GCS therapy (\=20 mg prednisone or equivalent/day) provided that the dose has been stable for 2 weeks prior to visit 1b, or oral Budesonide MMX® therapy (9 mg/day) initiated at least 8 weeks before visit 1b, provided that the dose has been stable for 2 weeks prior to visit 1b.

Exclusion Criteria

•Exclusion Criteria: Induction
•1\. Suspicion of differential diagnosis such as Crohn’s enterocolitis, ischaemic colitis, radiation colitis, indeterminate colitis, infectious colitis, diverticular disease, associated colitis, microscopic colitis, massive pseudopolyposis or non\-passable stenosis.
•2\. Acute fulminant UC, toxic megacolon and/or signs of systemic toxicity.
•3\. UC limited to the rectum (disease extending \<15 cm above the anal verge) or extending beyond the splenic flexure.
•4\. Have failed treatment with more than three advanced therapies (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab or tofacitinib) of two different therapeutic classes (anti\-TNF, anti\-integrins, anti\-IL12/23, JAKinhibitors, or other approved advanced therapies for UC).
•5\. Have had surgery for treatment of UC.
•6\. History of malignancy, unless treated with no relapse of the disease and \= 5 years since last treatment (cured) or treated (cured) basal cell or squamous cell in situ carcinoma.
•7\. History or presence of any clinically significant disorder that, in the opinion of the investigator, could impact on the participant’s ability to adhere to the protocol and protocol procedures, or would confound the study result or compromise participant safety.
•8\. Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies such as infliximab, adalimumab, golimumab, vedolizumab, ustekinumab or tofacitinib, or similar immunosuppressants and immunomodulators at enrolment.
•Any prior treatment with such drugs must have been discontinued at least 8 weeks prior to visit 1b (except for ustekinumab, which must have been discontinued at least 12 weeks prior to visit 1 b) or have non\-measurable serum concentration levels.