Ulcerative ColitisPhase 2CoTikiSNCT04882007
Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis
A Phase 2 study testing OSE-127 in people with Ulcerative Colitis, run by OSE Immunotherapeutics at 55 sites in 11 countries.
Trial summary
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- OSE-127
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 55 sitesin 11 countries
- Study dates
- 2 Oct 2020to 28 Jan 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
- OR
- Previous or current biologic therapy
Who cannot join
- 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
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- 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.
- Breastfeeding
- Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) from screening through the end of the study
- 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)
- 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)
- 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)
Trial locations and contacts
55 sites in 11 countries.
55 sites in 11 countries
Bulgaria10 sites
Medical Center Medconsult Pleven - OOD
Pleven
Medical Center Medconsult Pleven
Pleven
Acibadem City Clinic University Multiprofile Hospital for Active Treatment - EOOD, Clinic of Gastroenterology
Sofia
Medical Center Asklepion - Researches in humane medicine (EOOD)
Sofia
Medical Center Asklepion
Sofia
Medical Center Hera EOOD
Sofia
Medical Center Hera
Sofia
UMHAT Tsaritsa Yoanna - ISUL - EAD
Sofia
Medical center VIP Clinic - OOD
Varna
Medical Center VIP Clinic
Varna
Ukraine8 sites
Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital - Dnipropetrovsk Regional Council
Dnipro
Prof. O.O. Salimov City Clinical Hospital #2 - Kharkiv City Council
Kharkiv
Kryvyi Rih City Clinical Hospital #2
Kryvyi Rih
Kyiv Regional Clinical Hospital - Kyiv Regional Council
Kyiv
Medical Center OK!Clinic+ of International Institute of Clinical Studies LLC
Kyiv
Ternopil University Hospital - Ternopil Regional Council
Ternopil
Andrii Novak Transcarpathian Regional Clinical Hospital
Uzhhorod
Municipal Institution City Clinical Hospital #6 - Therapeutic Department
Zaporizhzhya
Poland7 sites
Centrum Opieki Zdrowotnej Orkan-med
Ksawerów
Centrum Medyczne Med-Gastr
Lodz
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej
Lodz
Medicome Sp. z o.o.
Oświęcim
Centrum Medyczne Medyk
Rzeszów
WIP Warsaw IBD Point Profesor Kierkus
Warsaw
Melita Medical
Wroclaw
Russia7 sites
Prof. S.V. Ochapovskiy Regional Clinical Hospital No.1
Krasnodar
Ryzhikh State Coloproctology Research Center
Moscow
LLC Novosibirskiy Gastrocenter
Novosibirsk
Medical Center Healthy Family LLC
Novosibirsk
State Budgetary Healthcare Institution of the Stavropol Region - Pyatigorsk Oncology Dispensary
Pyatigorsk
Saratov State Medical University
Saratov
Ekaterinburg City Clinical Hospital No. 14
Yekaterinburg
Georgia6 sites
EVEX Hospitals JSC
Kutaisi
West Regional Center of Modern Medical Technologies Ltd
Kutaisi
Institute of Clinical Cardiology
Tbilisi
Israel-Georgia Medical Research Clinic Helsicore Ltd
Tbilisi
JSC Clinic Jerarsi
Tbilisi
Multiprofile Clinic Consilium Medulla Ltd
Tbilisi
Belarus5 sites
Brest Regional Hospital
Brest
Grodno University Hospital
Grodno
Gomel Regional Clinical Hospital
Homyel
City Clinical Emergency Hospital
Minsk
Vitebsk Regional Clinical Hospital
Vitebsk
Latvia4 sites
Polana-D
Daugavpils
Liepāja Regional Hospital
Liepāja
Digestive Diseases Centre GASTRO
Riga
Pauls Stradins Clinical University Hospital
Riga
Belgium3 sites
UZ Leuven - Department of Gastroenterology and Hepatology
Leuven
CHU Liège
Liège
Groupe Santé CHC - Clinique du Mont Légia
Liège
Hungary3 sites
Clinexpert SMO
Budapest
II. Sz. Belgyogyaszati Klinika, Semmelweis Egyetem
Budapest
II. Sz Belgyogyasztai Intezet, Gasztroenterologia Debreceni Egyetem
Debrecen
About this study
Official title: 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)
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
- Being tested
- OSE-127, Placebo
- Keywords
- ulcerative colitis, inflammatory bowel diseases, Auto-Immune Diseases, CD127/IL-7Rα Antagonist
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSE-127Drug
mAb antagonist to CD127 receptor (or IL-7Rα)
PlaceboDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: OSE-127 |
| Placebo induction phase | Placebo comparator | Normal saline intravenous infusion 3 total infusions, weeks 0, 2, and 6 Receives: 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 Receives: Drug: OSE-127 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Modified Mayo Score (MMS) at Week 10
The Mayo Score measures disease activity for UC. The modified questionnaire has 3 domains (instead of the usual 4): 2 with questions answered by the patient (stool frequency and rectal bleeding) and 1 answered by an endoscopist (mucosal appearance at endoscopy). Each domain is graded from 0 to 3, higher values representing a worse outcome. Total score for modified Mayo Score is calculated as the sum of the three sub-scores, and ranges from 0 to 9.
Measured: From Baseline to Week 10
Secondary outcomes (2)
Clinical Remission Rate at Week 10
Clinical remission rate*: percentage of participants in clinical remission, defined as MMS ≤ 2 points and no individual sub-score of > 1 point and a rectal bleeding at 0. *The clinical remission rate is reported with imputation.
Measured: Week 10
Endoscopic Remission Rate at Week 10
Endoscopic remission rate*: percentage of participants with an endoscopic remission, defined by an endoscopic Mayo sub-score = 0. *The endoscopic remission rate is reported with imputation.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start2 Oct 2020
- Primary completion30 Apr 2024
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSE Immunotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silvia Comis, MD, Study director, OSE Immunotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882007
- Sponsor's protocol ID
- OSE-127-C201
- Other IDs
- 2020-001398-59
- Acronym
- CoTikiS
- Status last verified
- May 2026
- First submitted
- 13 Apr 2021
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided