CALDOSE - 1
Research type
Research Study
Full title
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 in moderate-to-severe ulcerative colitis
IRAS ID
241283
Contact name
Sami Hoque
Contact email
Sponsor organisation
Immunic AG
Eudract number
2017-003703-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease (IBD) affecting the rectum and colon. The prevalence of IBD continues to increase steadily in Western countries, and newly industrialized countries have a rapidly increasing incidence.
Symptoms of an UC flare-up generally involve diarrhoea, abdominal pain and cramping, rectal pain and bleeding, fatigue, and urgent bowel movements.
Several treatment options are currently available including anti-inflammatory drugs and other drugs to manage specific symptoms.
However, some patients respond only poorly to established treatment options or, after an initial response, experience flare-ups, and/or develop intolerable side effects. Thus, new treatment options are needed.
The investigational medicinal product (IMP) IMU-838 (vidofludimus calcium) is a new compound that selectively inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and may represent a novel and efficacious oral treatment option for IBD patients.
Study P2-IMU-838-UC will further evaluate the dose response, as well as efficacy and safety of vidofludimus, using the novel formulation IMU-838, in patients with active, moderate-to-severe UC.
This is a phase 2, multicenter, randomized, double-blind, and placebo-controlled trial in patients with moderate-to-severe UC with an option for open-label treatment extension. The study comprises a blinded induction phase to establish the optimal dose of IMU-838 to induce response and remission, a blinded maintenance phase to evaluate the potential of IMU-838 to maintain remission until Week 50, and an open-label treatment extension arm for all patients who discontinue the blinded phase as scheduled or prematurely, subject to certain restrictions. A subset of patients will undergo a PK period at the start of the open-label period to establish a full single-dose PK profile.
The study is funded by Immunic AG and it is planned to include about 90 study centers in a variety of countries of the European Union, Serbia, Russia, Ukraine, and the United States of America.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/0448
Date of REC Opinion
3 May 2018
REC opinion
Further Information Favourable Opinion