IMU-838 for Ulcerative Colitis (CALDOSE-1 Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Immunic AG

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests IMU-838, a new drug for treating moderate-to-severe ulcerative colitis. It works by blocking an enzyme to reduce active immune cells and inflammation. The study aims to find the best dose and see if it can maintain remission.

Eligibility Criteria

Adults aged 18-80 with moderate-to-severe ulcerative colitis diagnosed over 3 months ago, who have not responded well to certain treatments. They must meet specific health criteria and agree to use effective contraception. Excluded are those with other bowel diseases, serious infections or illnesses, recent live vaccinations, or a history of drug/alcohol abuse.

Inclusion Criteria

My ulcerative colitis extends more than 15 cm from the anal verge.

I did not respond well to previous immune or biological treatments.

I agree not to father a child or donate sperm and will follow the contraception guidelines.

My condition meets certain criteria based on Mayo scores and endoscopy results.

My symptoms improved significantly by Week 10 or 22 of treatment.

Exclusion Criteria

I have not used any experimental drugs or certain medications recently.

I have a history of kidney stones, liver, kidney issues, gout, or Gilbert syndrome.

I have had colorectal cancer or precancerous colon changes.

I have been diagnosed with a specific gastrointestinal condition.

I have not received a live vaccine recently.

I have a history of long-term infections.

Treatment Details

The trial is testing IMU-838's effectiveness for treating ulcerative colitis compared to a placebo. It's in phase 2 and includes an induction phase for initial treatment response and a maintenance phase for long-term effects, plus an optional open-label extension for further evaluation.

8Treatment groups

Experimental Treatment

Placebo Group

Group I: 45 mg IMU-838 (Induction)Experimental Treatment1 Intervention

Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients will receive only half of their assigned full dose during the first week of treatment.

Group II: 30 mg IMU-838 (Open-label)Experimental Treatment1 Intervention

Two 15 mg tablets once daily of IMU-838 or one 30 mg tablet IMU-838 once daily for up to 10 years and up to 3 years in UK sites

Group III: 30 mg IMU-838 (Maintenance)Experimental Treatment1 Intervention

Two 15 mg tablets once daily of IMU-838 until Week 50 or ulcerative colitis relapse.

Group IV: 30 mg IMU-838 (Induction)Experimental Treatment1 Intervention

Two 15 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients will receive only half of their assigned full dose during the first week of treatment.

Group V: 10 mg IMU-838 (Maintenance)Experimental Treatment1 Intervention

Two 5 mg tablets once daily of IMU-838 until Week 50 or ulcerative colitis relapse.

Group VI: 10 mg IMU-838 (Induction)Experimental Treatment1 Intervention

Two 5 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients will receive only half of their assigned full dose during the first week of treatment.

Group VII: placebo (Induction)Placebo Group1 Intervention

The placebo tablets will be identical to the IMU-838 tablets in terms of appearance, constitution of inactive ingredients, and packaging.

Group VIII: placebo (Maintenance)Placebo Group1 Intervention

The placebo tablets will be identical to the IMU-838 tablets in terms of appearance, constitution of inactive ingredients, and packaging. Patients who have received placebo during the induction phase will be 're-randomized' to continue to receive placebo (in a blinded fashion).