MedTrace Logo

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

NCT04985968 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2023-12-27

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

Conditions

Interventions

DRUG

Cobitolimod 250 mg

Rectal administration

DRUG

Cobitolimod 500 mg

Rectal administration

DRUG

Placebo

Rectal administration

Sponsors & Collaborators

  • InDex Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Raja Atreya, Professor · Friedrich-Alexander University Erlangen-Nuremberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2023-12-20
Completion
2023-12-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Canada
  • Croatia
  • Denmark
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Slovakia
  • South Korea
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985968 on ClinicalTrials.gov