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

NCT04882007 | Completed Phase 2 DMC

• 2 other identifiers: OSE-127-C2012020-001398-59
• Study Type: interventional
• Target: 136
• Locations: 10 countries
• Sites: 52

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis; inflammatory bowel diseases; Auto-Immune Diseases; CD127/IL-7Rα Antagonist

Outcome Measures

Primary Outcomes (1)

• Change in modified Mayo Score

  Change in modified Mayo Score between baseline and Week 10 clinical symptoms (stool frequency and rectal bleeding sub-scores) additionally to the endoscopic sub-score

  Baseline and Week 10

Secondary Outcomes (6)

• Clinical Remission

  Week 10

• Clinical efficacy of OSE-127 vs placebo

  Week 10

• Efficacy of OSE-127 vs placebo on endoscopic remission

  Week 10

• Efficacy of OSE-127 vs placebo on endoscopic improvement

  Week 10

• Efficacy of OSE-127 vs placebo on endoscopic improvement

  Week 10

Study Arms (4)

OSE-127 High dose induction phase

EXPERIMENTAL

OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 3 total infusions, weeks 0, 2, and 6

Drug: OSE-127

OSE-127 Low dose induction phase

EXPERIMENTAL

OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 3 total infusions, weeks 0, 2, and 6

Drug: OSE-127

Placebo induction phase

PLACEBO COMPARATOR

Normal saline intravenous infusion 3 total infusions, weeks 0, 2, and 6

Drug: Placebo

OSE-127 High dose optional extension phase

EXPERIMENTAL

OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 7 total infusions, weeks 10, 14, 18, 22, 26, 30, and 34

Drug: OSE-127

Interventions

OSE-127 DRUG

mAb antagonist to CD127 receptor (or IL-7Rα)

OSE-127 High dose induction phase; OSE-127 High dose optional extension phase; OSE-127 Low dose induction phase

Placebo DRUG

Normal saline

Placebo induction phase

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No previous biologic therapy (i.e., TNF antagonists, vedolizumab or ustekinumab) and prior or current UC documented medication history that includes at least 1 of the following:
• Corticosteroids
• Immunosuppressive agents
• Previous or current biologic therapy

You may not qualify if:

• 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
• Neutrophils \< 1500/mm3
• Lymphocytes \< 800/mm3
• Absolute white blood cell (WBC) count \< 3000/mm3
• Crohn's disease or indeterminate colitis or any other diagnosis not consisting with UC
• History or evidence of incompletely resected colonic dysplasia or unconventional lesion at risk of colonic adenocarcinoma
• Stool culture or other examination positive for enteric pathogen, including Clostridium difficile (C. diff) toxin. If positive, the patient should be treated and rescreening is allowed.
• Men or women with childbearing potential not willing to use adequate birth control during the study. Adequate birth control includes surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, double-barrier method (condom, diaphragm with spermicide), or abstinence during study and 30 days following the last follow-up visit. Women of childbearing potential will enter the study after a negative pregnancy test.

Sponsors & Collaborators

• OSE Immunotherapeutics: lead

Study Sites (55)

Brest Regional Hospital

Brest, Belarus

Location

Grodno University Hospital

Grodno, Belarus

Location

Gomel Regional Clinical Hospital

Homyel, Belarus

Location

City Clinical Emergency Hospital

Minsk, Belarus

Location

Vitebsk Regional Clinical Hospital

Vitebsk, Belarus

Location

UZ Leuven - Department of Gastroenterology and Hepatology

Leuven, Belgium

Location

CHU Liège

Liège, Belgium

Location

Groupe Santé CHC - Clinique du Mont Légia

Liège, Belgium

Location

Medical Center Medconsult Pleven - OOD

Pleven, Bulgaria

Location

Medical Center Medconsult Pleven

Pleven, Bulgaria

Location

Acibadem City Clinic University Multiprofile Hospital for Active Treatment - EOOD, Clinic of Gastroenterology

Sofia, Bulgaria

Location

Medical Center Asklepion - Researches in humane medicine (EOOD)

Sofia, Bulgaria

Location

Medical Center Asklepion

Sofia, Bulgaria

Location

Medical Center Hera EOOD

Sofia, Bulgaria

Location

Medical Center Hera

Sofia, Bulgaria

Location

UMHAT Tsaritsa Yoanna - ISUL - EAD

Sofia, Bulgaria

Location

Medical center VIP Clinic - OOD

Varna, Bulgaria

Location

Medical Center VIP Clinic

Varna, Bulgaria

Location

University Hospital Center Split

Split, Croatia

Location

EVEX Hospitals JSC

Kutaisi, Georgia

Location

West Regional Center of Modern Medical Technologies Ltd

Kutaisi, Georgia

Location

Institute of Clinical Cardiology

Tbilisi, Georgia

Location

Israel-Georgia Medical Research Clinic Helsicore Ltd

Tbilisi, Georgia

Location

JSC Clinic Jerarsi

Tbilisi, Georgia

Location

Multiprofile Clinic Consilium Medulla Ltd

Tbilisi, Georgia

Location

Clinexpert SMO

Budapest, Hungary

Location

II. Sz. Belgyogyaszati Klinika, Semmelweis Egyetem

Budapest, Hungary

Location

II. Sz Belgyogyasztai Intezet, Gasztroenterologia Debreceni Egyetem

Debrecen, Hungary

Location

Polana-D

Daugavpils, Latvia

Location

Liepāja Regional Hospital

Liepāja, Latvia

Location

Digestive Diseases Centre GASTRO

Riga, Latvia

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Centrum Opieki Zdrowotnej Orkan-med

Ksawerów, Poland

Location

Centrum Medyczne Med-Gastr

Lodz, Poland

Location

Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej

Lodz, Poland

Location

Medicome Sp. z o.o.

Oświęcim, Poland

Location

Centrum Medyczne Medyk

Rzeszów, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Location

Melita Medical

Wroclaw, Poland

Location

Prof. S.V. Ochapovskiy Regional Clinical Hospital No.1

Krasnodar, Russia

Location

Ryzhikh State Coloproctology Research Center

Moscow, Russia

Location

LLC Novosibirskiy Gastrocenter

Novosibirsk, Russia

Location

Medical Center Healthy Family LLC

Novosibirsk, Russia

Location

State Budgetary Healthcare Institution of the Stavropol Region - Pyatigorsk Oncology Dispensary

Pyatigorsk, Russia

Location

Saratov State Medical University

Saratov, Russia

Location

Ekaterinburg City Clinical Hospital No. 14

Yekaterinburg, Russia

Location

301 Fairfield Medical Suite

Cape Town, South Africa

Location

Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital - Dnipropetrovsk Regional Council

Dnipro, Ukraine

Location

Prof. O.O. Salimov City Clinical Hospital #2 - Kharkiv City Council

Kharkiv, Ukraine

Location

Kryvyi Rih City Clinical Hospital #2

Kryvyi Rih, Ukraine

Location

Kyiv Regional Clinical Hospital - Kyiv Regional Council

Kyiv, Ukraine

Location

Medical Center OK!Clinic+ of International Institute of Clinical Studies LLC

Kyiv, Ukraine

Location

Ternopil University Hospital - Ternopil Regional Council

Ternopil, Ukraine

Location

Andrii Novak Transcarpathian Regional Clinical Hospital

Uzhhorod, Ukraine

Location

Municipal Institution City Clinical Hospital #6 - Therapeutic Department

Zaporizhzhya, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Silvia Comis, MD

  OSE Immunotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the Double-blind phase all participants will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 11, 2021
• Study Start: October 2, 2020
• Primary Completion: April 30, 2024
• Study Completion: January 28, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-03

Locations

RU (7); LA (4); UA (8); HU (3); PL (7); ZA (1); BE (5); CR (1); GE (6); BU (10)