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

January 12, 2021 updated by: InDex Pharmaceuticals

A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

213

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia
        • 1
  • France
      • Amiens, France
        • 2
      • Caen, France
        • 3
      • Clichy, France
        • 4
      • Grenoble, France
        • 5
      • Nice, France
        • 6
      • Pierre-Bénite, France
        • 7
      • Saint-Étienne, France
        • 8
      • Toulouse, France
        • 9
      • Vandœuvre-lès-Nancy, France
        • 10
  • Germany
      • Augsburg, Germany
        • 11
      • Berlin, Germany
        • 12
      • Erlangen, Germany
        • 13
      • Hamburg, Germany
        • 14
      • Hanover, Germany
        • 15
      • Heidelberg, Germany
        • 16
      • Leipzig, Germany
        • 17
      • Lüneburg, Germany
        • 18
      • Mannheim, Germany
        • 19
      • München, Germany
        • 20
  • Hungary
      • Budapest, Hungary
        • 21
      • Békéscsaba, Hungary
        • 22
      • Debrecen, Hungary
        • 23
      • Mosonmagyarovar, Hungary
        • 24
      • Pécs, Hungary
        • 25
  • Poland
      • Czestochowa, Poland
        • 26
      • Kraków, Poland
        • 27
      • Ksawerów, Poland
        • 28
      • Lublin, Poland
        • 29
      • Poznań, Poland
        • 30
      • Sopot, Poland
        • 31
      • Warszawa, Poland
        • 32
      • Wrocław, Poland
        • 33
      • Włocławek, Poland
        • 32
      • Łódź, Poland
        • 33
  • Russian Federation
      • Cheboksary, Russian Federation
        • 34
      • Ekaterinburg, Russian Federation
        • 35
      • Kazan, Russian Federation
        • 36
      • Kirov, Russian Federation
        • 37
      • Moscow, Russian Federation
        • 38
      • Novosibirsk, Russian Federation
        • 39
      • Ryazan', Russian Federation
        • 40
      • Saint Petersburg, Russian Federation
        • 41
      • Stavropol', Russian Federation
        • 42
      • Tver, Russian Federation
        • 43
      • Ufa, Russian Federation
        • 44
  • Serbia
      • Belgrad, Serbia
        • 45
  • Spain
      • Ferrol, Spain
        • 46
      • Fuenlabrada, Spain
        • 47
      • Madrid, Spain
        • 48
      • Sevilla, Spain
        • 49
      • Valencia, Spain
        • 50
  • Sweden
      • Uppsala, Sweden
        • 51
  • Ukraine
      • Chernivtsi, Ukraine
        • 52
      • Dnipropetrovs'k, Ukraine
        • 53
      • Ivano-Frankivs'k, Ukraine
        • 54
      • Kharkiv, Ukraine
        • 55
      • Kiev, Ukraine
        • 56
      • Luts'k, Ukraine
        • 57
      • Lviv, Ukraine
        • 58
      • Odesa, Ukraine
        • 59
      • Sumy, Ukraine
        • 60
      • Zaporizhzhya, Ukraine
        • 61
      • Úzhgorod, Ukraine
        • 62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Kappaproct
Experimental: Cobitolimod Dose 2x125 mg
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
Drug: cobitolimod
Rectal administration
Other Names:
  • Kappaproct
Experimental: Cobitolimod Dose 2x250 mg
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
Drug: cobitolimod
Rectal administration
Other Names:
  • Kappaproct
Experimental: Cobitolimod Dose 4x125 mg
Dose 125 mg of cobitolimod, at 4 occasions
Drug: cobitolimod
Rectal administration
Other Names:
  • Kappaproct
Placebo Comparator: Placebo
Placebo at four occasions
Drug: Placebo
Solution manufactured to mimic cobitolimod
Other Names:
  • Placebo (for cobitolimod)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks after first treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 6
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)
Week 6
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)
Week 6
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)
Week 6
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
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InDex Pharmaceuticals

Investigators

  • Principal Investigator: Raja Atreya, Friedrich-Alexander University Erlangen-Nuremberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSUC-01/16
  • 2016-004217-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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