Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)

OSE Immunotherapeutics0 sites140 target enrollmentDecember 7, 2020

ConditionsModerate to severe Ulcerative Colitis MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856 Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to severe Ulcerative Colitis
Sponsor: OSE Immunotherapeutics
Enrollment: 140
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 7, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OSE Immunotherapeutics

Eligibility Criteria

Inclusion Criteria

•1\. 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
•2\. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
•3\. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
•4\. Male or female 18 to 75 years of age, inclusive
•5\. 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 (i.e., histopathology report available in the patient’s fil, however a biopsy for a local histopathology assessment at screening can substitute this requirement).
•\*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 sub\-score, the stool frequency sub\-score, and the endoscopic sub\-score. Thus, to be included, a patient must have the following:
•a.a rectal bleeding score \= 1,
•b.a stool frequency score \= 1 (sub\-score calculated before bowel preparation), and
•c.an endoscopic sub\-score \= 2
•6\. Previous or current biologic therapy for UC with documented history of a primary non clinical response or, a secondary loss of response to at least 1 of the following agents used at a dose and regimens approved for the treatment of UC for sufficient time (including approved biosimilars):

Exclusion Criteria

•1\. Stoma, proctocolectomy, or subtotal colectomy
•2\. Physician judgment that patient is likely to require any surgery for UC during the study duration, or double\-blind phase duration at least
•3\. Evidence of fulminant colitis, toxic megacolon, or perforation
•4\. Current or recent (within 4 weeks prior to screening) hospitalization for UC care and/or treatment with IV steroids
•5\. The following laboratory results at screening:
•a. Elevation at screening of aspartate 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
•b. Platelet count \< 100,000/mm3
•c. Hemoglobin (Hgb) \< 8\.5 g/dL
•d. Neutrophils \< 1500/mm3
•e. Lymphocytes \< 800/mm3