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New antibody aims to calm ulcerative colitis when other treatments fail

NCT ID NCT04882007

Disease control Sponsor: OSE Immunotherapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether OSE-127, an antibody that blocks a key immune signal, can reduce disease activity in people with moderate to severe ulcerative colitis who have not responded to or cannot tolerate previous treatments. Participants are randomly assigned to receive either OSE-127 or a placebo, and neither they nor their doctors know which they receive. The main goal is to see if the drug improves a combined score of symptoms and endoscopic findings after 10 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OSE-127 (a monoclonal antibody that blocks the IL-7 receptor)
What this could lead to
If successful, OSE-127 could offer a new treatment option for people with ulcerative colitis who have not been helped by existing therapies.
What could go wrong
This is an early phase 2 study with a small number of participants, so results may not apply to everyone. The drug may not work better than placebo or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

136 people

The number who actually took part.

Started

Oct 2020

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • 301 Fairfield Medical Suite

    Cape Town, South Africa

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

    Sofia, Bulgaria

  • Andrii Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, Ukraine

  • Brest Regional Hospital

    Brest, Belarus

  • CHU Liège

    Liège, Belgium

  • Centrum Medyczne Med-Gastr

    Lodz, Poland

  • Centrum Medyczne Medyk

    Rzeszów, Poland

  • Centrum Opieki Zdrowotnej Orkan-med

    Ksawerów, Poland

  • City Clinical Emergency Hospital

    Minsk, Belarus

  • Clinexpert SMO

    Budapest, Hungary

  • Digestive Diseases Centre GASTRO

    Riga, Latvia

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

    Dnipro, Ukraine

  • EVEX Hospitals JSC

    Kutaisi, Georgia

  • Ekaterinburg City Clinical Hospital No. 14

    Yekaterinburg, Russia

  • Gomel Regional Clinical Hospital

    Homyel, Belarus

  • Grodno University Hospital

    Grodno, Belarus

  • Groupe Santé CHC - Clinique du Mont Légia

    Liège, Belgium

  • II. Sz Belgyogyasztai Intezet, Gasztroenterologia Debreceni Egyetem

    Debrecen, Hungary

  • II. Sz. Belgyogyaszati Klinika, Semmelweis Egyetem

    Budapest, Hungary

  • Institute of Clinical Cardiology

    Tbilisi, Georgia

  • Israel-Georgia Medical Research Clinic Helsicore Ltd

    Tbilisi, Georgia

  • JSC Clinic Jerarsi

    Tbilisi, Georgia

  • Kryvyi Rih City Clinical Hospital #2

    Kryvyi Rih, Ukraine

  • Kyiv Regional Clinical Hospital - Kyiv Regional Council

    Kyiv, Ukraine

  • LLC Novosibirskiy Gastrocenter

    Novosibirsk, Russia

  • Liepāja Regional Hospital

    Liepāja, Latvia

  • Medical Center Asklepion

    Sofia, Bulgaria

  • Medical Center Asklepion - Researches in humane medicine (EOOD)

    Sofia, Bulgaria

  • Medical Center Healthy Family LLC

    Novosibirsk, Russia

  • Medical Center Hera

    Sofia, Bulgaria

  • Medical Center Hera EOOD

    Sofia, Bulgaria

  • Medical Center Medconsult Pleven

    Pleven, Bulgaria

  • Medical Center Medconsult Pleven - OOD

    Pleven, Bulgaria

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

    Kyiv, Ukraine

  • Medical Center VIP Clinic

    Varna, Bulgaria

  • Medical center VIP Clinic - OOD

    Varna, Bulgaria

  • Medicome Sp. z o.o.

    Oświęcim, Poland

  • Melita Medical

    Wroclaw, Poland

  • Multiprofile Clinic Consilium Medulla Ltd

    Tbilisi, Georgia

  • Municipal Institution City Clinical Hospital #6 - Therapeutic Department

    Zaporizhzhya, Ukraine

  • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej

    Lodz, Poland

  • Pauls Stradins Clinical University Hospital

    Riga, Latvia

  • Polana-D

    Daugavpils, Latvia

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

    Kharkiv, Ukraine

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

    Krasnodar, Russia

  • Ryzhikh State Coloproctology Research Center

    Moscow, Russia

  • Saratov State Medical University

    Saratov, Russia

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

    Pyatigorsk, Russia

  • Ternopil University Hospital - Ternopil Regional Council

    Ternopil, Ukraine

  • UMHAT Tsaritsa Yoanna - ISUL - EAD

    Sofia, Bulgaria

  • UZ Leuven - Department of Gastroenterology and Hepatology

    Leuven, Belgium

  • University Hospital Center Split

    Split, Croatia

  • Vitebsk Regional Clinical Hospital

    Vitebsk, Belarus

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, Poland

  • West Regional Center of Modern Medical Technologies Ltd

    Kutaisi, Georgia

More trials for these conditions

Other studies related to the condition(s) this trial covers.