What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include 5-aminosalicylates (5-ASA), glucocorticoids, and immunomodulators. 5-ASA agents, such as mesalamine, can cause side effects like nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, such as prednisone, are associated with long-term side effects including adrenal suppression, osteoporosis, and increased infection risk. Immunomodulators, like azathioprine and 6-mercaptopurine, can lead to bone marrow suppression, liver toxicity, and increased risk of infections. Specific side effects for Cobitolimod, a Toll-like receptor 9 agonist, are not detailed, but similar treatments may cause gastrointestinal symptoms and immune-related effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including aminosalicylates (e.g., mesalamine), corticosteroids (e.g., prednisone), immunomodulators (e.g., azathioprine), and biologics (e.g., infliximab, adalimumab). These treatments target various aspects of the immune response to reduce inflammation and maintain remission. While specific information on FDA approvals for Toll-like receptor 9 agonists like Cobitolimod is limited, the focus on immune modulation is consistent with the broader strategy of managing UC through targeted immune therapies.

What other types of research exist?

Promising novel alternatives to Cobitolimod for Ulcerative Colitis patients include: 1) Ustekinumab, an interleukin-12 and interleukin-23 inhibitor, 2) Vedolizumab, an anti-integrin agent, and 3) Risankizumab, an interleukin-23 inhibitor. These agents have shown efficacy in clinical trials and are considered effective options for UC treatment.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

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

Do I qualify?Apply below to find out

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

Common treatments for Ulcerative Colitis (UC) include aminosalicylates, which reduce inflammation in the colon lining; corticosteroids, which suppress the immune response to decrease inflammation; immunomodulators like azathioprine and 6-mercaptopurine, which alter the immune system to prevent ongoing inflammation; and biologics, such as anti-TNF agents, which target specific proteins involved in the inflammatory process. Cobitolimod, a Toll-like receptor 9 (TLR9) agonist, works by modulating the immune response to reduce inflammation and promote mucosal healing. This is particularly important for UC patients as it offers a targeted approach to managing inflammation, potentially leading to better long-term outcomes and fewer side effects compared to broader immunosuppressive therapies.

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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

~49 spots leftby Jun 2025

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