What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include aminosalicylates, corticosteroids, immunomodulators, and biologics. Aminosalicylates can cause headaches, nausea, and abdominal pain. Corticosteroids are associated with weight gain, osteoporosis, and increased infection risk. Immunomodulators like azathioprine and 6-mercaptopurine can lead to bone marrow suppression, liver toxicity, and increased lymphoma risk. Biologics, such as anti-TNF agents, may cause injection site reactions, infections, and rare cases of lymphoma. Treatments similar to IMU-838, which inhibit dihydroorotate dehydrogenase, may reduce the proliferation of activated T and B cells, potentially leading to side effects like immunosuppression, increased infection risk, and liver enzyme abnormalities.

What prior FDA approvals exist?

FDA-approved treatments for Ulcerative Colitis that involve immunomodulation include drugs like azathioprine and 6-mercaptopurine, which are thiopurines that suppress the immune system by interfering with DNA synthesis in immune cells. Additionally, biologic agents such as infliximab and adalimumab, which are anti-TNF antibodies, have been approved for UC. These treatments, while not identical to IMU-838, share the common goal of reducing immune cell activity to control inflammation.

What other types of research exist?

Promising novel alternatives to IMU-838 for Ulcerative Colitis patients include: <ol> <li>Ustekinumab - a monoclonal antibody targeting interleukin-12 and interleukin-23.</li> <li></li> </ol> Vedolizumab - a monoclonal antibody targeting the alpha4beta7 integrin. 3. Risankizumab - a monoclonal antibody targeting interleukin-23. These agents have shown efficacy in clinical trials for inflammatory bowel diseases and offer different mechanisms of action compared to IMU-838.

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Immunomodulator

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

Phase 2

Waitlist Available

Research Sponsored by Immunic AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Endoscopic appearance typical for UC and extending >15 cm from the anal verge

Previous treatment failure defined as inadequate response, lost response to, or intolerance to approved or experimental immunomodulators or biologics

Must not have

Recent use of investigational products or specific medications

History of nephrolithiasis, liver function impairment, renal impairment, gout, or Gilbert syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4 ole, week 8 ole, week 10 ole, week 12 ole, week 16 ole, week 20 ole, week 24 ole, week 28 ole, week 32 or 38 ole (depending if entry was after extended induction phase), eot up to 4 years (variable)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects of IMU-838 aren't detailed here, similar medications can cause digestive issues, liver function changes, increased infection risk due to immune system impact, potential allergic reactions and possibly affect blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had colorectal cancer or precancerous colon changes.

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I have been diagnosed with a specific gastrointestinal condition.

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I have not received a live vaccine recently.

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I have a history of long-term infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4 ole, week 8 ole, week 10 ole, week 12 ole, week 16 ole, week 20 ole, week 24 ole, week 28 ole, week 32 or 38 ole (depending if entry was after extended induction phase), eot up to 4 years (variable)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4 ole, week 8 ole, week 10 ole, week 12 ole, week 16 ole, week 20 ole, week 24 ole, week 28 ole, week 32 or 38 ole (depending if entry was after extended induction phase), eot up to 4 years (variable)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 ole, week 8 ole, week 10 ole, week 12 ole, week 16 ole, week 20 ole, week 24 ole, week 28 ole, week 32 or 38 ole (depending if entry was after extended induction phase), eot up to 4 years (variable) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Induction Phase: Symptomatic Remission and Endoscopic Healing at Week 10

Secondary study objectives

Induction Phase: C-reactive Protein (CRP)

Induction Phase: Fecal Calprotectin (fCP)

Induction Phase: Full Mayo Score

+38 more

Side effects data

From 2021 Phase 2 & 3 trial • 234 Patients • NCT04379271

21%

Hypertriglyceridaemia

Glycosylated haemoglobin increased

Headache

Haematuria

Tachycardia

Sinus bradycardia

Hypertensive crisis

Hyperglycaemia

Alanine aminotransferase increased

Hypertension

Anaemia

Bradycardia

Hepatocellular injury

Death

100%

80%

60%

40%

20%

Study treatment Arm

IMU-838

Placebo

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IMU-838

2020

Completed Phase 3

~280

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) work by targeting different aspects of the inflammatory process. IMU-838, which inhibits dihydroorotate dehydrogenase (DHODH), reduces the proliferation of activated T and B cells, thereby decreasing inflammation. This is particularly important for UC patients as it directly addresses the overactive immune response that characterizes the disease. Other treatments include 5-aminosalicylates, which reduce inflammation in the lining of the colon, corticosteroids that suppress the overall immune response, and immunomodulators like azathioprine and 6-mercaptopurine, which alter the immune system to maintain remission. Understanding these mechanisms helps in tailoring treatment plans to effectively manage and control UC symptoms.