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The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis

NCT03178669 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2021-02-01

Study results available
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Summary

The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.

Conditions

Interventions

DRUG

cobitolimod

Rectal administration

DRUG

Placebo

Solution manufactured to mimic cobitolimod

Sponsors & Collaborators

  • InDex Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Raja Atreya · 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
2017-06-21
Primary Completion
2019-08-30
Completion
2019-08-30

Countries

  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • Russia
  • Serbia
  • Spain
  • Sweden
  • Ukraine

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 NCT03178669 on ClinicalTrials.gov