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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: OSE-127

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belarus
  • Brest, Belarus
    • Brest Regional Hospital
  • Grodno, Belarus
    • Grodno University Hospital
  • Homyel, Belarus
    • Gomel Regional Clinical Hospital
  • Minsk, Belarus
    • City Clinical Emergency Hospital
  • Vitebsk, Belarus
    • Vitebsk Regional Clinical Hospital
• Belgium
  • Leuven, Belgium
    • UZ Leuven - Department of Gastroenterology and Hepatology
  • Liège, Belgium
    • Chu Liege
  • Liège, Belgium
    • Groupe Santé CHC - Clinique du Mont Légia
• Bulgaria
  • Pleven, Bulgaria
    • Medical Center Medconsult Pleven
  • Pleven, Bulgaria
    • Medical Center Medconsult Pleven - OOD
  • Sofia, Bulgaria
    • Medical Center Hera EOOD
  • Sofia, 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
  • Sofia, Bulgaria
    • UMHAT Tsaritsa Yoanna - ISUL - EAD
  • Varna, Bulgaria
    • Medical center VIP Clinic - OOD
  • Varna, Bulgaria
    • Medical Center VIP Clinic
• Croatia
  • Split, Croatia
    • University Hospital Center Split
• Georgia
  • Kutaisi, Georgia
    • EVEX Hospitals JSC
  • Kutaisi, Georgia
    • West Regional Center of Modern Medical Technologies Ltd
  • Tbilisi, Georgia
    • Multiprofile Clinic Consilium Medulla Ltd
  • Tbilisi, Georgia
    • Institute of Clinical Cardiology
  • Tbilisi, Georgia
    • Israel-Georgia Medical Research Clinic Helsicore Ltd
  • Tbilisi, Georgia
    • JSC Clinic Jerarsi
• Hungary
  • Budapest, Hungary
    • Clinexpert SMO
  • Budapest, Hungary
    • II. Sz. Belgyogyaszati Klinika, Semmelweis Egyetem
  • Debrecen, Hungary
    • II. Sz Belgyogyasztai Intezet, Gasztroenterologia Debreceni Egyetem
• Latvia
  • Daugavpils, Latvia
    • Polana-D
  • Liepāja, Latvia
    • Liepaja Regional Hospital
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia
    • Digestive Diseases Centre GASTRO
• Poland
  • Ksawerów, Poland
    • Centrum Opieki Zdrowotnej Orkan-med
  • Lodz, Poland
    • Centrum Medyczne Med-Gastr
  • Lodz, Poland
    • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej
  • Oświęcim, Poland
    • Medicome Sp. z o.o.
  • Rzeszów, Poland
    • Centrum Medyczne Medyk
  • Warsaw, Poland
    • WIP Warsaw IBD Point Profesor Kierkus
  • Wroclaw, Poland
    • Melita Medical
• Russia
  • Krasnodar, Russia
    • Prof. S.V. Ochapovskiy Regional Clinical Hospital No.1
  • Moscow, Russia
    • Ryzhikh State Coloproctology Research Center
  • Novosibirsk, Russia
    • LLC Novosibirskiy Gastrocenter
  • Novosibirsk, Russia
    • Medical Center Healthy Family LLC
  • Pyatigorsk, Russia
    • State Budgetary Healthcare Institution of the Stavropol Region - Pyatigorsk Oncology Dispensary
  • Saratov, Russia
    • Saratov State Medical University
  • Yekaterinburg, Russia
    • Ekaterinburg City Clinical Hospital No. 14
• South Africa
  • Cape Town, South Africa
    • 301 Fairfield Medical Suite
• Ukraine
  • Dnipro, Ukraine
    • Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital - Dnipropetrovsk Regional Council
  • Kharkiv, Ukraine
    • Prof. O.O. Salimov City Clinical Hospital #2 - Kharkiv City Council
  • Kryvyi Rih, Ukraine
    • Kryvyi Rih City Clinical Hospital #2
  • Kyiv, Ukraine
    • Kyiv Regional Clinical Hospital - Kyiv Regional Council
  • Kyiv, Ukraine
    • Medical Center OK!Clinic+ of International Institute of Clinical Studies LLC
  • Ternopil, Ukraine
    • Ternopil University Hospital - Ternopil Regional Council
  • Uzhhorod, Ukraine
    • Andrii Novak Transcarpathian Regional Clinical Hospital
  • Zaporizhzhya, Ukraine
    • Municipal Institution City Clinical Hospital #6 - Therapeutic Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: OSE-127; mAb antagonist to CD127 receptor (or IL-7Rα)
Experimental: 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	Drug: OSE-127; mAb antagonist to CD127 receptor (or IL-7Rα)
Placebo Comparator: Placebo induction phase; Normal saline intravenous infusion 3 total infusions, weeks 0, 2, and 6	Drug: Placebo; Normal saline
Experimental: 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	Drug: OSE-127; mAb antagonist to CD127 receptor (or IL-7Rα)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Baseline to Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Week 10

Collaborators and Investigators

• Sponsor: OSE Immunotherapeutics
• Investigators: Study Director: Silvia Comis, MD, OSE Immunotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): January 28, 2025

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: May 8, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ulcerative colitis; inflammatory bowel diseases; Auto-Immune Diseases; CD127/IL-7Rα Antagonist
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
• Other Study ID Numbers: OSE-127-C201; 2020-001398-59 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No