The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis (CONDUCT)
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| ClinicalTrials.gov Identifier: NCT03178669 |
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Recruitment Status :
Completed
First Posted : June 7, 2017
Results First Posted : February 1, 2021
Last Update Posted : February 1, 2021
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Sponsor:
InDex Pharmaceuticals
Information provided by (Responsible Party):
InDex Pharmaceuticals
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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 |
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 (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
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cobitolimod Dose 2x31 mg
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
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Drug: cobitolimod
Rectal administration
Other Name: Kappaproct |
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Experimental: Cobitolimod Dose 2x125 mg
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
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Drug: cobitolimod
Rectal administration
Other Name: Kappaproct |
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Experimental: Cobitolimod Dose 2x250 mg
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
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Drug: cobitolimod
Rectal administration
Other Name: Kappaproct |
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Experimental: Cobitolimod Dose 4x125 mg
Dose 125 mg of cobitolimod, at 4 occasions
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Drug: cobitolimod
Rectal administration
Other Name: Kappaproct |
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Placebo Comparator: Placebo
Placebo at four occasions
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Drug: Placebo
Solution manufactured to mimic cobitolimod
Other Name: Placebo (for cobitolimod) |
Primary Outcome Measures :
- 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 :
- 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
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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
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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
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
Show 64 study locations
Sponsors and Collaborators
InDex Pharmaceuticals
Investigators
| Principal Investigator: | Raja Atreya | Friedrich-Alexander University Erlangen-Nuremberg |
Study Documents (Full-Text)
Documents provided by InDex Pharmaceuticals:
Documents provided by InDex Pharmaceuticals:
Study Protocol and Statistical Analysis Plan [PDF] January 19, 2017
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by InDex Pharmaceuticals:
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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 |