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Cobitolimod for Ulcerative Colitis (CONCLUDE Trial)

Phase 3
Waitlist Available
Led By Raja Atreya, Professor
Research Sponsored by InDex Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

CONCLUDE Trial Summary

This trial is testing whether a new drug called cobitolimod can help people with left-sided ulcerative colitis.

Who is the study for?
This trial is for adults over 18 with moderate to severe active left-sided Ulcerative Colitis (UC) who haven't had success with standard treatments like steroids, immunosuppressants, biologics, or JAK-inhibitors. Participants must be able to understand and follow the study's procedures after giving informed consent.Check my eligibility
What is being tested?
The trial tests Cobitolimod at two different doses (250 mg and 500 mg) against a placebo to see if it can induce clinical remission in UC patients. It also looks at whether Cobitolimod can maintain remission up to week 52 for those responding by week 6.See study design
What are the potential side effects?
While specific side effects of Cobitolimod are not listed here, common side effects from similar ulcerative colitis treatments include headache, nausea, fatigue, abdominal pain, and possible injection site reactions.

CONCLUDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 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 - Proportion of participants with clinical remission.
Maintenance - Proportion of participants with clinical remission.
Secondary outcome measures
Induction - Mean 3-component and 4-component Mayo scores.
Induction - Mean IBDQ total score.
Induction - Mean ln-transformed faecal calprotectin.
+25 more

CONCLUDE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cobitolimod 500 mgExperimental Treatment1 Intervention
Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week
Group II: Cobitolimod 250 mgExperimental Treatment1 Intervention
Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week
Group III: PlaceboPlacebo Group1 Intervention
Dose of Placebo 2 treatments during induction study and subsequently every third week

Find a Location

Who is running the clinical trial?

InDex PharmaceuticalsLead Sponsor
3 Previous Clinical Trials
350 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
219 Patients Enrolled for Ulcerative Colitis
Raja Atreya, ProfessorPrincipal InvestigatorFriedrich-Alexander University Erlangen-Nuremberg

Media Library

Cobitolimod 250 mg Clinical Trial Eligibility Overview. Trial Name: NCT04985968 — Phase 3
Ulcerative Colitis Research Study Groups: Cobitolimod 250 mg, Cobitolimod 500 mg, Placebo
Ulcerative Colitis Clinical Trial 2023: Cobitolimod 250 mg Highlights & Side Effects. Trial Name: NCT04985968 — Phase 3
Cobitolimod 250 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT04985968 — Phase 3
Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT04985968 — Phase 3

Frequently Asked Questions

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

Are there any other instances of Cobitolimod 250 mg being used in a medical capacity?

"As of right now, there is one ongoing clinical trial for Cobitolimod 250 mg that is in Phase 3. The primary research site is in Soeul, Florida, but there are 25 different locations conducting this trial."

Answered by AI

Have there been similar clinical trials to this one in the past?

"Cobitolimod 250 mg has been studied since early 2021 when InDex Pharmaceuticals ran an initial 440-person clinical trial. After the successful completion of Phase 3 drug approval, there is now a single active study being sponsored by the same company."

Answered by AI

Has Cobitolimod 250 mg met the FDA's requirements for safety and efficacy?

"There is some data to suggest that Cobitolimod 250mg is effective and multiple rounds of testing have shown that it is safe, so it received a score of 3."

Answered by AI

What is the main reason for conducting this research?

"The key metric that this study will use to measure success is the number of participants in clinical remission after approximately 6 weeks. Additionally, the study will also track participants' IBDQ total score (as defined by the Inflammatory Bowel Disease Questionnaire) and faecal calprotectin levels."

Answered by AI

Is there space for more volunteers in this research project?

"This study is actively seeking patients, as reported on clinicaltrials.gov. The study was originally posted on 11/24/2021 and was most recently updated on 8/24/2022."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
Virginia
Other
What site did they apply to?
Dayton Gastroenterology
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I think I have stomach problems.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
2021. "The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04985968.
~50 spots leftby Apr 2025
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