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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03178669
Recruitment Status : Completed
First Posted : June 7, 2017
Results First Posted : February 1, 2021
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
InDex Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.

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

Detailed Description:

This was a Phase IIb study in patients with moderate to severe left-sided ulcerative colitis. Patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. To ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. Blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. Primary endpoint was evaluated at week 6.

Duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 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
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cobitolimod Dose 2x31 mg
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
 Drug: cobitolimod
Rectal administration
Other Name: Kappaproct
Experimental: Cobitolimod Dose 2x125 mg
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
 Drug: cobitolimod
Rectal administration
Other Name: Kappaproct
Experimental: Cobitolimod Dose 2x250 mg
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
 Drug: cobitolimod
Rectal administration
Other Name: Kappaproct
Experimental: Cobitolimod Dose 4x125 mg
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)


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Remission [ Time Frame: 6 weeks after first treatment ]
    Patients with clinical remission at Week 6 (yes=1, no=0), 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, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).


Secondary Outcome Measures :
  1. Modified Clinical Remission [ Time Frame: Week 6 ]
    Patients with modified clinical remission at Week 6 (yes=1, no=0), 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, Week 0), iii) endoscopy score of 0 or 1 (excluding friability ) and iiii) physician´s global assessment (PGA) of 0 or 1

  2. Symptomatic Remission [ Time Frame: Week 6 ]
    Patients with symptomatic remission at Week 6 (yes=1, no=0), 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, Week 0), (patient reported outcome)

  3. Clinical Response [ Time Frame: Week 6 ]
    Patients with clinical response at Week 6 (yes=1, no=0), defined as clinical remission or a three point and ≥30 % decrease from Baseline, Week 0 in the sum of the Modified Mayo score, i) rectal bleeding, ii) stool frequency and iii) endoscopy score (excluding friability), iiii) physicians global assessment (PGA)

  4. Endoscopic Remission [ Time Frame: Week 6 ]
    Patients with endoscopic remission at Week 6 (yes=1, no=0), defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)

  5. Histological Remission [ Time Frame: Week 6 ]
    Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1


Eligibility Criteria
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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 Ulcerative Colitis (UC)
  • Moderately to severely active left sided UC assessed by central reading
  • Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
  • Current Glucocorticosteroids (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
    • Tumor Necrosis Factor alpha (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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
InDex Pharmaceuticals
Investigators
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Principal Investigator: Raja Atreya Friedrich-Alexander University Erlangen-Nuremberg
  Study Documents (Full-Text)

Documents provided by InDex Pharmaceuticals:
Study Protocol and Statistical Analysis Plan  [PDF] January 19, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: InDex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03178669    
Other Study ID Numbers: CSUC-01/16
2016-004217-26 ( EudraCT Number )
First Posted: June 7, 2017    Key Record Dates
Results First Posted: February 1, 2021
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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