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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
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)
Awards & highlights

CALDOSE-1 Trial Summary

This trial is testing a new drug, IMU-838, to see if it is effective and safe for treating ulcerative colitis.

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.Check my eligibility
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.See study design
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.

CALDOSE-1 Trial 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.

CALDOSE-1 Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Induction Phase: Symptomatic Remission and Endoscopic Healing at Week 10
Secondary outcome measures
Induction Phase: C-reactive Protein (CRP)
Induction Phase: Fecal Calprotectin (fCP)
Induction Phase: Full Mayo Score
+38 more

CALDOSE-1 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
~270

Find a Location

Who is running the clinical trial?

Immunic AGLead Sponsor
7 Previous Clinical Trials
3,039 Total Patients Enrolled
Andreas MuehlerStudy DirectorImmunic Therapeutics
1 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

IMU-838 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT03341962 — Phase 2
Ulcerative Colitis Research Study Groups: placebo (Induction), placebo (Maintenance), 10 mg IMU-838 (Induction), 30 mg IMU-838 (Induction), 45 mg IMU-838 (Induction), 10 mg IMU-838 (Maintenance), 30 mg IMU-838 (Maintenance), 30 mg IMU-838 (Open-label)
Ulcerative Colitis Clinical Trial 2023: IMU-838 Highlights & Side Effects. Trial Name: NCT03341962 — Phase 2
IMU-838 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03341962 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is the implementation of this trial?

"This clinical trial is accepting patients from a number of different medical facilities, including Digestive Health Specialists in Tacoma, Washington, Del Sol Research Management LLC in Tucson Arizona and Axis Clinical Trials in Los Angeles California. In addition to these 3 sites there are 11 other locations that are also participating."

Answered by AI

What are the eligibility requirements for participation in this trial?

"Eligible participants for this medical study must be afflicted with ulcers and fall between the age of 18 to 80. A total of 263 patients is needed for proper evaluation."

Answered by AI

Has IMU-838 been previously examined in experimental protocols?

"IMU-838 was first studied in 2018 at Eastern Research, Inc. and has since been the subject of 18,327 completed trials. At present, 4 new studies are actively seeking participants with many of these trials being conducted near Tacoma, Washington."

Answered by AI

Are there still opportunities to participate in the trial?

"The information provided by clinicaltrials.gov indicates that, while this study was initially posted on March 15th 2018 and edited most recently in October 21st 2022, there is not presently any recruitment for it. However, 412 other medical trials are actively recruiting patients."

Answered by AI

Does this trial cater to geriatric patients?

"The requirements for enrollment in this clinical trial mandate that participants must be aged between 18 and 80. For those below the age of consent, there are 70 different trials available while 349 exist for individuals over 65 years old."

Answered by AI

What is the projected recruitment rate for participants in this trial?

"Recruitment for this medical trial has ceased. The study, posted on March 15th 2018 and last edited October 21st 2022, is now inactive. If you are seeking alternate clinical trials, 408 studies involving ulcer patients as well as 4 trials using IMU-838 currently have open enrolment requirements."

Answered by AI

Is this endeavor a pioneering medical experiment?

"Presently, 4 clinical trials involving IMU-838 are occurring in 27 cities and 25 nations. Immunic AG launched the first research project back in 2018 which included 263 participants and achieved Phase 2 approval status. Since then, over 18 thousand experiments have taken place."

Answered by AI

Is there any evidence to suggest that IMU-838 has adverse effects on patients?

"Although there are some data points suggesting IMU-838's safety, the absence of proof for efficacy places its safety rating at 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2 Dose-finding IMU-838 for Ulcerative Colitis
2018. "Phase 2 Dose-finding IMU-838 for Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03341962.
~37 spots leftby Apr 2025
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