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Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

NCT03341962 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2024-03-05

Study results available
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Summary

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment extension in moderate-to-severe ulcerative colitis (CALDOSE-1).

Conditions

Interventions

DRUG

IMU-838

IMU-838 tablet

DRUG

Placebo

Tablets manufactured to mimic IMU-838 tablets

Sponsors & Collaborators

  • Immunic AG

    lead INDUSTRY

Principal Investigators

  • Andreas Muehler · Immunic Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2022-11-16
Completion
2022-11-16
FDA Drug
Yes

Countries

  • United States
  • Albania
  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Czechia
  • Georgia
  • Netherlands
  • North Macedonia
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • 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 NCT03341962 on ClinicalTrials.gov