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

NCT ID: NCT04882007

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-02
• Study Completion Date: 2025-01-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OSE-127 High dose induction phase

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

Group Type: EXPERIMENTAL

OSE-127

Intervention Type: DRUG

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

OSE-127 Low dose induction phase

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

Group Type: EXPERIMENTAL

OSE-127

Intervention Type: DRUG

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

Placebo induction phase

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline

OSE-127 High dose optional extension phase

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

Group Type: EXPERIMENTAL

OSE-127

Intervention Type: DRUG

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

Interventions

OSE-127

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

Intervention Type: DRUG

Placebo

Normal saline

Intervention Type: DRUG

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 (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:

1. a rectal bleeding score ≥ 1,

2. a stool frequency score ≥ 1 (sub-score calculated before bowel preparation), and

3. an endoscopic sub-score ≥ 2

6. 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:

1. Corticosteroids

2. Immunosuppressive agents

OR

Previous or current biologic therapy

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:

1. 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

2. Platelet count < 100,000/mm3

3. Hemoglobin (Hgb) < 8.5 g/dL

4. Neutrophils < 1500/mm3

5. Lymphocytes < 800/mm3

6. Absolute white blood cell (WBC) count < 3000/mm3

6. Crohn's disease or indeterminate colitis or any other diagnosis not consisting with UC

7. History or evidence of incompletely resected colonic dysplasia or unconventional lesion at risk of colonic adenocarcinoma

8. 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.

9. 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.

10. Breastfeeding

11. Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) from screening through the end of the study

12. Use of topical steroids and/or topical 5-aminosalicylic acid preparations within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)

13. Use of antidiarrheals within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)

14. Treatment with azathioprine, 6-MP, methotrexate (MTX), cyclosporin, tacrolimus, sirolimus, leflunomide and/or mycophenolate mofetil within 4 weeks before the screening visit (all such medications should be withdrawn at least 4 weeks prior to the screening visit)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSE Immunotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Comis, MD

Role: STUDY_DIRECTOR

OSE Immunotherapeutics

Locations

Brest Regional Hospital

Brest, , Belarus

Grodno University Hospital

Grodno, , Belarus

Gomel Regional Clinical Hospital

Homyel, , Belarus

City Clinical Emergency Hospital

Minsk, , Belarus

Vitebsk Regional Clinical Hospital

Vitebsk, , Belarus

UZ Leuven - Department of Gastroenterology and Hepatology

Leuven, , Belgium

CHU Liège

Liège, , Belgium

Groupe Santé CHC - Clinique du Mont Légia

Liège, , Belgium

Medical Center Medconsult Pleven - OOD

Pleven, , Bulgaria

Medical Center Medconsult Pleven

Pleven, , Bulgaria

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

Sofia, , Bulgaria

Medical Center Asklepion - Researches in humane medicine (EOOD)

Sofia, , Bulgaria

Medical Center Asklepion

Sofia, , Bulgaria

Medical Center Hera EOOD

Sofia, , Bulgaria

Medical Center Hera

Sofia, , Bulgaria

UMHAT Tsaritsa Yoanna - ISUL - EAD

Sofia, , Bulgaria

Medical center VIP Clinic - OOD

Varna, , Bulgaria

Medical Center VIP Clinic

Varna, , Bulgaria

University Hospital Center Split

Split, , Croatia

EVEX Hospitals JSC

Kutaisi, , Georgia

West Regional Center of Modern Medical Technologies Ltd

Kutaisi, , Georgia

Institute of Clinical Cardiology

Tbilisi, , Georgia

Israel-Georgia Medical Research Clinic Helsicore Ltd

Tbilisi, , Georgia

JSC Clinic Jerarsi

Tbilisi, , Georgia

Multiprofile Clinic Consilium Medulla Ltd

Tbilisi, , Georgia

Clinexpert SMO

Budapest, , Hungary

II. Sz. Belgyogyaszati Klinika, Semmelweis Egyetem

Budapest, , Hungary

II. Sz Belgyogyasztai Intezet, Gasztroenterologia Debreceni Egyetem

Debrecen, , Hungary

Polana-D

Daugavpils, , Latvia

Liepāja Regional Hospital

Liepāja, , Latvia

Digestive Diseases Centre GASTRO

Riga, , Latvia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Centrum Opieki Zdrowotnej Orkan-med

Ksawerów, , Poland

Centrum Medyczne Med-Gastr

Lodz, , Poland

Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej

Lodz, , Poland

Medicome Sp. z o.o.

Oświęcim, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Melita Medical

Wroclaw, , Poland

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

Krasnodar, , Russia

Ryzhikh State Coloproctology Research Center

Moscow, , Russia

LLC Novosibirskiy Gastrocenter

Novosibirsk, , Russia

Medical Center Healthy Family LLC

Novosibirsk, , Russia

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

Pyatigorsk, , Russia

Saratov State Medical University

Saratov, , Russia

Ekaterinburg City Clinical Hospital No. 14

Yekaterinburg, , Russia

301 Fairfield Medical Suite

Cape Town, , South Africa

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

Dnipro, , Ukraine

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

Kharkiv, , Ukraine

Kryvyi Rih City Clinical Hospital #2

Kryvyi Rih, , Ukraine

Kyiv Regional Clinical Hospital - Kyiv Regional Council

Kyiv, , Ukraine

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

Kyiv, , Ukraine

Ternopil University Hospital - Ternopil Regional Council

Ternopil, , Ukraine

Andrii Novak Transcarpathian Regional Clinical Hospital

Uzhhorod, , Ukraine

Municipal Institution City Clinical Hospital #6 - Therapeutic Department

Zaporizhzhya, , Ukraine

Countries

Belarus; Belgium; Bulgaria; Croatia; Georgia; Hungary; Latvia; Poland; Russia; South Africa; Ukraine

Other Identifiers

2020-001398-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OSE-127-C201

Identifier Type: -

Identifier Source: org_study_id