CompletedPhase 2

Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

Belarus136 participantsStarted 2020-10-02

Plain-language summary

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Provision of signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment
✓. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
✓. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
✓. Male or female 18 to 75 years of age, inclusive
✓. Diagnosis of moderate to severe active UC made at least 3 months before the screening visit. The diagnosis of UC must have been confirmed by endoscopy, with a minimal extent of 15 cm from anal margin and histology (Moderate to severe active UC is defined by a modified Mayo score between 4 and 9, inclusive. The modified Mayo score is defined by the addition of the rectal bleeding subscore, the stool frequency sub-score, and the endoscopic sub-score. Thus, to be included, a patient must have the following:
✓. a rectal bleeding score ≥ 1,
✓. a stool frequency score ≥ 1 (sub-score calculated before bowel preparation), and
✓. an endoscopic sub-score ≥ 2

Exclusion criteria

✕. Stoma, proctocolectomy, or subtotal colectomy
✕. Physician judgment that patient is likely to require any surgery for UC during the study duration, or double-blind phase duration at least
✕. Evidence of fulminant colitis, toxic megacolon, or perforation
✕. Current or recent (within 4 weeks prior to screening) hospitalization for UC care and/or treatment with IV steroids
✕. The following laboratory results at screening:
✕. Elevation at screening of aminotransferase (AST), alanine aminotransferase (ALT) \> 3 × the upper limit of normal (ULN) or total bilirubin \> 2 × ULN (unless due to Gilbert's disease) or evidence of chronic liver disease
✕. Platelet count \< 100,000/mm3
✕. Hemoglobin (Hgb) \< 8.5 g/dL

What they're measuring

Change in modified Mayo Score

Timeframe: Baseline and Week 10

Trial details

NCT IDNCT04882007

SponsorOSE Immunotherapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-30

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