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Trial record 2 of 3 for:    cobitolimod | Ulcerative Colitis

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (CONCLUDE)

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ClinicalTrials.gov Identifier: NCT04985968
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
InDex Pharmaceuticals

Brief Summary:
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Cobitolimod 250 mg Drug: Cobitolimod 500 mg Drug: Placebo Phase 3

Detailed Description:

This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks.

In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Actual Study Start Date : November 24, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cobitolimod 250 mg

Dose of 250 mg cobitolimod

2 treatments during induction study and subsequently every third week

Drug: Cobitolimod 250 mg
Rectal administration

Experimental: Cobitolimod 500 mg

Dose of 500 mg cobitolimod

2 treatments during induction study and subsequently every third week

Drug: Cobitolimod 500 mg
Rectal administration

Placebo Comparator: Placebo

Dose of Placebo

2 treatments during induction study and subsequently every third week

Drug: Placebo
Rectal administration




Primary Outcome Measures :
  1. Induction - Proportion of participants with clinical remission. [ Time Frame: Week 6 ]
    Clinical remission defined by the 3-component Mayo score.

  2. Maintenance - Proportion of participants with clinical remission. [ Time Frame: Week 52 ]
    Clinical remission defined by the 3-component Mayo score.


Secondary Outcome Measures :
  1. Induction - Proportion of participants with endoscopic improvement. [ Time Frame: Week 6 ]
    Endoscopic improvement defined by the Mayo Endoscopic score.

  2. Induction - Proportion of participants with symptomatic remission. [ Time Frame: Week 6 ]
    Symptomatic remission defined by the 2-component Mayo score.

  3. Induction - Proportion of participants with clinical response. [ Time Frame: Week 6 ]
    Clinical remission defined by the 3-component Mayo score.

  4. Induction - Proportion of participants with normalisation of stool frequency. [ Time Frame: Week 6 ]
    Stool frequency defined by the Mayo score for Stool Frequency.

  5. Induction - Proportion of participants with absence of rectal bleeding. [ Time Frame: Week 6 ]
    Rectal bleeding defined by the Mayo score for Rectal Bleeding.

  6. Induction - Mean stool frequency. [ Time Frame: Week 6 ]
    Mean stool frequency defined by the Mayo score for Stool Frequency.

  7. Induction - Proportion of participants with histologic improvement. [ Time Frame: Week 6 ]
    Defined by the Robarts Histologic Index.

  8. Induction - Proportion of participants with histologic remission. [ Time Frame: Week 6 ]
    Histologic remission defined by the Robarts Histologic Index.

  9. Induction - Proportion of participants with mucosal healing. [ Time Frame: Week 6 ]
    Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.

  10. Induction - Mean ln-transformed faecal calprotectin. [ Time Frame: Week 6 ]
    Mean ln-transformed faecal calprotectin defined by faecal calprotectin values.

  11. Induction - Mean 3-component and 4-component Mayo scores. [ Time Frame: Week 6 ]
    Defined by 3-component and 4-component Mayo scores.

  12. Induction - Mean IBDQ total score. [ Time Frame: Week 6 ]
    Defined by the Inflammatory Bowel Disease Questionnaire (IBDQ).

  13. Induction - Proportion of participants with an improvement in IBDQ total score. [ Time Frame: Week 6 ]
    Defined by the IBDQ.

  14. Maintenance - Proportion of participants with endoscopic improvement. [ Time Frame: Week 52 ]
    Endoscopic improvement defined by the Mayo Endoscopic score.

  15. Maintenance - Proportion of participants with clinical remission and steroid-free. [ Time Frame: Week 52 ]
    Defined by the 3-component Mayo score and use of glucocorticosteroids.

  16. Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission [ Time Frame: Week 52 ]
    Defined by the 3-component Mayo score.

  17. Maintenance - Proportion of participants with symptomatic remission. [ Time Frame: Week 52 ]
    Symptomatic remission defined by the 2-component Mayo score.

  18. Maintenance - Proportion of participants with histologic improvement. [ Time Frame: Week 52 ]
    Histologic improvement defined by the Robarts Histologic Index.

  19. Maintenance - Proportion of participants with histologic remission. [ Time Frame: Week 52 ]
    Histologic remission defined by the Robarts Histologic Index.

  20. Maintenance - Proportion of participants with mucosal healing. [ Time Frame: Week 52 ]
    Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.

  21. Maintenance - Proportion of participants with clinical response. [ Time Frame: Week 52 ]
    Clinical response defined by the 3-component Mayo score.

  22. Maintenance - Proportion of participants with absence of rectal bleeding. [ Time Frame: Week 52 ]
    Rectal bleeding defined by the Mayo score for Rectal Bleeding.

  23. Maintenance - Proportion of participants with normalisation of stool frequency. [ Time Frame: Week 52 ]
    Stool frequency defined by the Mayo score for Stool Frequency.

  24. Maintenance - Mean stool frequency. [ Time Frame: Week 52 ]
    Mean stool frequency defined by the Mayo score for Stool Frequency.

  25. Maintenance - Mean ln-transformed faecal calprotectin. [ Time Frame: Week 52 ]
    Mean ln-transformed faecal calprotectin.

  26. Maintenance - Mean 3-component and 4-component Mayo scores. [ Time Frame: Week 52 ]
    Defined by 3-component and 4-component Mayo scores.

  27. Maintenance - Mean IBDQ total score. [ Time Frame: Week 52 ]
    Defined by the use of the Inflammatory Bowel Disease Questionnaire (IBDQ).

  28. Maintenance - Proportion of participants with an improvement in IBDQ total score. [ Time Frame: Week 52 ]
    Defined by the IBDQ.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Induction:

  • Male or female ≥ 18 years of age.
  • Established diagnosis of UC.
  • Moderate to severe active left-sided UC assessed by central reading.
  • Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
  • Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
  • Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.

Exclusion Criteria Induction:

  • Suspicion of differential diagnosis.
  • Acute fulminant UC and/or signs of systemic toxicity.
  • UC limited to the rectum or extending beyond the splenic flexure.
  • Have failed treatment with more than three advanced therapies of two different therapeutic classes.
  • Have had surgery for treatment of UC.
  • History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).
  • History or presence of any clinically significant disorder.
  • Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
  • Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
  • Long-term treatment (>14 days) with antibiotics or NSAIDs .
  • Serious known active infection including history of latent or active tuberculosis.
  • Gastrointestinal infections including positive Clostridium difficile stool assay.
  • Females who are lactating or have a positive serum pregnancy test.
  • Women of childbearing potential not using highly effective contraceptive methods.
  • Concurrent participation in another clinical study.
  • Previous exposure to cobitolimod.

Inclusion Criteria Maintenance:

  • Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.

Exclusion Criteria Maintenance:

  • Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985968


Contacts
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Contact: InDex Pharmaceuticals +46 8 122 038 50 info@indexpharma.com
Contact: Karin Arnesson, CTM +46 8 122 038 57 karin.arnesson@indexpharma.com

Locations
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Hungary
Pannónia Magánorvosi Centrum Kft Recruiting
Budapest, Hungary
Sponsors and Collaborators
InDex Pharmaceuticals
Investigators
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Principal Investigator: Raja Atreya, Professor Friedrich-Alexander University Erlangen-Nuremberg
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Responsible Party: InDex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04985968    
Other Study ID Numbers: CSUC-01/21
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by InDex Pharmaceuticals:
Colitis, Ulcerative
Cobitolimod
Gastrointestinal Disease
Inflammatory Bowel Diseases
Glucocorticosteroids
Anti-Inflammatory Agents
Therapeutic uses
Toll like receptor 9 agonist
TLR9 agonist
Kappaproct
IDX0150
DIMS0150
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases