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The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis (CONDUCT)

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ClinicalTrials.gov Identifier: NCT03178669
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
InDex Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe active ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: cobitolimod Drug: Placebo Phase 2

Detailed Description:

This is a Phase 2b study in patients with moderate to severe active ulcerative colitis. Patients will either receive cobitolimod dose A, B or C at two occasions or dose B or placebo at four occasions. To ensure blindness patients receiving active treatment at two occasions will receive placebo at the other two occasions. Blood, stool, and tissue samples will be collected at various time points throughout the study to evaluate safety and efficacy.

Duration of participation for patients will be approximately 12 weeks.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cobitolimod Dose 31 mg x 2
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
Drug: cobitolimod
Rectal administration
Other Name: Kappaproct

Experimental: Cobitolimod Dose 125 mg x 2
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
Drug: cobitolimod
Rectal administration
Other Name: Kappaproct

Experimental: Cobitolimod Dose 250 mg x 2
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
Drug: cobitolimod
Rectal administration
Other Name: Kappaproct

Experimental: Cobitolimod Dose 125 mg x 4
Dose 125 mg of cobitolimod, at 4 occasions
Drug: cobitolimod
Rectal administration
Other Name: Kappaproct

Placebo Comparator: Placebo
Placebo at four occasions
Drug: Placebo
Solution manufactured to mimic cobitolimod
Other Name: Placebo (for cobitolimod)




Primary Outcome Measures :
  1. Clinical Remission [ Time Frame: 6 weeks after first treatment ]
    defined by Modified Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, and iii) endoscopy score of 0 or 1 (excluding friability)


Secondary Outcome Measures :
  1. Symptomatic Remission [ Time Frame: Week 4 and Week 6 ]
    defined by the Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, (patient reported outcome) [PRO2]

  2. Abscence of rectal bleeding [ Time Frame: Week 4 and Week 6 ]
    defined by the Mayo sub score rectal bleeding of 0

  3. Normal or enhanced stool frequency [ Time Frame: Week 4 and Week 6 ]
    defined by the Mayo sub score stool frequency of 0 or 1 (with at least one point decrease from Baseline)

  4. Endoscopic Remission [ Time Frame: Week 6 ]
    defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)

  5. Histological Remission [ Time Frame: Week 6 ]
    defined by the Nancy histological index

  6. Histological Response [ Time Frame: Week 6 ]
    defined by the Nancy histological index score

  7. Modified Clinical Remission [ Time Frame: Week 6 ]
    defined by the Modified Mayo score ≤ 2 and sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline), iii) endoscopy score of 0 or 1 (excluding friability ) and iiii) physician´s global assessment (PGA) of 0 or 1

  8. Clinical Response [ Time Frame: Week 6 ]
    defined as clinical remission or a three point and ≥ 30% decrease from Baseline.

  9. Change in faecal calprotectin [ Time Frame: Week 1,2, 3 and 6 ]
    defined as a mean change compared to Baseline

  10. Change in the inflammatory bowel disease questionnaire (IBDQ) [ Time Frame: Week 6 ]
    defined as mean change compared to Baseline



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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:

  • Age ≥ 18 years old
  • Established diagnosis of UC
  • Moderately to severely active left sided UC assessed by central reading
  • Current oral 5-ASA/SP use or a history of oral 5-ASA/SP use
  • Current GCS use or history of GCS dependency, refractory, or intolerance
  • Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:

    • Immunomodulators
    • TNF-α inhibitors and/or anti-integrins

Exclusion Criteria:

  • Suspicion of differential diagnosis
  • Acute fulminant UC and/or signs of systemic toxicity
  • UC limited to the rectum (disease which extend <15 cm above the anal verge)
  • History of malignancy
  • History or presence of any clinically significant disorder
  • Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
  • Treatment with rectal GCS, 5-ASA/SP or tacrolimus
  • Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Serious active infection
  • Gastrointestinal infections
  • Currently receiving parenteral nutrition or blood transfusions
  • Females who are lactating or have a positive serum pregnancy test
  • Women of childbearing potential not using reliable contraceptive methods
  • Concurrent participation in another clinical study
  • Previous exposure to cobitolimod

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): NCT03178669


Contacts
Contact: InDex Pharmaceuticals +46 8 508 847 30 info@indexpharma.com
Contact: Karin Arnesson +46 8 508 847 34 karin.arnesson@indexpharma.com

  Show 64 Study Locations
Sponsors and Collaborators
InDex Pharmaceuticals
Investigators
Principal Investigator: Raja Atreya Friedrich-Alexander University Erlangen-Nuremberg

Responsible Party: InDex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03178669     History of Changes
Other Study ID Numbers: CSUC-01/16
2016-004217-26 ( EudraCT Number )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by InDex Pharmaceuticals:
Colitis, Ulcerative
Gastrointestinal Diseases
Inflammatory Bowel Disease
Immunomodulator Therapy
Glucocorticoids
Anti-Inflammatory Agents
Therapeutic uses
Kappaproct
IDX0150
DIMS0150

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases