Phase 2
N=211
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT03178669 ↗Enrolled (actual)
211
Serious AEs
4.7%
Results posted
Feb 2021
Primary outcome: Primary: Clinical Remission — 5; 2; 9; 4 Participants — p=0.1806
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cobitolimod (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- InDex Pharmaceuticals
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Remission |
5; 2; 9; 4; 3 | 0.1806 |
| SECONDARY Modified Clinical Remission |
5; 1; 7; 3; 3 | 0.2115 |
| SECONDARY Symptomatic Remission |
10; 11; 13; 10; 9 | 0.2335 |
| SECONDARY Clinical Response |
17; 18; 20; 15; 20 | 0.6326 |
| SECONDARY Endoscopic Remission |
7; 5; 15; 10; 12 | 0.7994 |
| SECONDARY Histological Remission |
4; 5; 8; 7; 10 | 0.9207 |
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.
Eligibility 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
- 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
Data sourced from ClinicalTrials.gov (NCT03178669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.