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The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients

NCT01493960 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2023-01-10

Study results available
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Summary

The purpose of this study is to determine if cobitolimod (former called Kappaproct®) is effective in the treatment of chronic active ulcerative colitis patients not responding to available therapy.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Cobitolimod

30 mg rectal dose at week 0 and 4

DRUG

Placebo

Rectal dose at week 0 and 4

Sponsors & Collaborators

  • InDex Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Christopher Hawkey, MD · Nottingham Digestive Diseases Centre, Queens Campus University Hospitals, Nottingham, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2014-03-31

Countries

  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01493960 on ClinicalTrials.gov