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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InDex Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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