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Trial record 1 of 3 for:    cobitolimod | Ulcerative Colitis
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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 : 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

Tracking Information
First Submitted Date  ICMJE June 5, 2017
First Posted Date  ICMJE June 7, 2017
Results First Submitted Date  ICMJE November 13, 2020
Results First Posted Date  ICMJE February 1, 2021
Last Update Posted Date February 1, 2021
Actual Study Start Date  ICMJE June 21, 2017
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
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, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • 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
  • 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)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • 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, Week 0), (patient reported outcome) [PRO2]
  • Abscence of rectal bleeding [ Time Frame: Week 4 and Week 6 ]
    defined by the Mayo sub score rectal bleeding of 0
  • Normal or enhanced stool frequenciy [ 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, Week 0)
  • Endoscopic Remission [ Time Frame: Week 6 ]
    defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)
  • Histological Remission [ Time Frame: Week 6 ]
    defined by the Nancy histological index
  • Histological Response [ Time Frame: Week 6 ]
    defined by the Nancy histological index score
  • 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, Week 0), iii) endoscopy score of 0 or 1 (excluding friability ) and iiii) physician´s global assessment (PGA) of 0 or 1
  • Clinical Response [ Time Frame: Week 6 ]
    defined as clinical remission of three point and ≥ 30% decrease from Baseline.
  • Change in faecal calprotectin [ Time Frame: Week 1,2, 3 and 6 ]
    defined as a mean change compared to Baseline
  • Change of the inflammatory bowel disease questionnaire (IBDQ) [ Time Frame: Week 6 ]
    defined as mean change compared to Baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
Official Title  ICMJE A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: cobitolimod
    Rectal administration
    Other Name: Kappaproct
  • Drug: Placebo
    Solution manufactured to mimic cobitolimod
    Other Name: Placebo (for cobitolimod)
Study Arms  ICMJE
  • Experimental: Cobitolimod Dose 2x31 mg
    Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
    Intervention: Drug: cobitolimod
  • Experimental: Cobitolimod Dose 2x125 mg
    Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
    Intervention: Drug: cobitolimod
  • Experimental: Cobitolimod Dose 2x250 mg
    Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
    Intervention: Drug: cobitolimod
  • Experimental: Cobitolimod Dose 4x125 mg
    Dose 125 mg of cobitolimod, at 4 occasions
    Intervention: Drug: cobitolimod
  • Placebo Comparator: Placebo
    Placebo at four occasions
    Intervention: Drug: Placebo
Publications * Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hébuterne X, Arnesson K, Knittel T, Kowalski J, Neurath MF, Sandborn WJ, Reinisch W; CONDUCT study group. Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial. Lancet Gastroenterol Hepatol. 2020 Dec;5(12):1063-1075. doi: 10.1016/S2468-1253(20)30301-0. Epub 2020 Oct 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2019)
213
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2017)
215
Actual Study Completion Date  ICMJE August 30, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Hungary,   Poland,   Russian Federation,   Serbia,   Spain,   Sweden,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03178669
Other Study ID Numbers  ICMJE CSUC-01/16
2016-004217-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InDex Pharmaceuticals
Study Sponsor  ICMJE InDex Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raja Atreya Friedrich-Alexander University Erlangen-Nuremberg
PRS Account InDex Pharmaceuticals
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP