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Completed

NCT Number: NCT03178669

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1, Prague, Czechia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cobitolimod

Drug

Rectal administration

Other names: Kappaproct

Placebo

Drug

Solution manufactured to mimic cobitolimod

Other names: Placebo (for cobitolimod)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

InDex Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: CONDUCT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2017
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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