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

June 20, 2025 updated by: OSE Immunotherapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belarus
      • Brest, Belarus
        • Brest Regional Hospital
      • Gomel, Belarus
        • Gomel Regional Clinical Hospital
      • Grodno, Belarus
        • Grodno University 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
      • Oświęcim, Poland
        • Medicome Sp. z o.o.
      • Rzeszów, Poland
        • Centrum Medyczne Medyk
      • Warszawa, Poland
        • WIP Warsaw IBD Point Profesor Kierkus
      • Wrocław, Poland
        • Melita Medical
      • Łódź, Poland
        • Centrum Medyczne Med-Gastr
      • Łódź, Poland
        • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • Ekaterinburg City Clinical Hospital No. 14
      • Krasnodar, Russian Federation
        • Prof. S.V. Ochapovskiy Regional Clinical Hospital No.1
      • Moscow, Russian Federation
        • Ryzhikh State Coloproctology Research Center
      • Novosibirsk, Russian Federation
        • LLC Novosibirskiy Gastrocenter
      • Novosibirsk, Russian Federation
        • Medical Center Healthy Family LLC
      • Pyatigorsk, Russian Federation
        • State Budgetary Healthcare Institution of the Stavropol Region - Pyatigorsk Oncology Dispensary
      • Saratov, Russian Federation
        • Saratov State Medical University
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in modified Mayo Score
Time Frame: Baseline and Week 10
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Remission
Time Frame: Week 10
Number and proportion of patients achieving clinical remission at Week 10, defined as a modified Mayo score of ≤ 2 points and with no individual sub-score of > 1 point and a rectal bleeding at 0, therefore a stool frequency score of 0 or 1 and an endoscopic score of 0 or 1
Week 10
Clinical efficacy of OSE-127 vs placebo
Time Frame: Week 10
Number and proportion of patients with a clinical response defined as a reduction in the modified Mayo score of ≥ 3 points and of ≥ 30% from baseline, with an accompanying decrease from baseline in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of ≤ 1 point
Week 10
Efficacy of OSE-127 vs placebo on endoscopic remission
Time Frame: Week 10
Number and proportion of patients with an endoscopic remission defined by an endoscopic Mayo sub-score =0
Week 10
Efficacy of OSE-127 vs placebo on endoscopic improvement
Time Frame: Week 10
Number and proportion of patients with endoscopic response or improvement defined by an endoscopic subscore of Mayo ≤ 1 point
Week 10
Efficacy of OSE-127 vs placebo on endoscopic improvement
Time Frame: Week 10
Mean change from baseline in the endoscopic activity measured by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
Week 10
Overall safety and tolerability of OSE-127 in patients with moderate to severe UC
Time Frame: Week 0 to Week 22 for patients not participating in the optional extension, and Week 0 to Week 50 for patients participating in the optional extension
Frequency and severity of reported treatment-emergent adverse events, serious adverse events
Week 0 to Week 22 for patients not participating in the optional extension, and Week 0 to Week 50 for patients participating in the optional extension

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OSE Immunotherapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Silvia Comis, MD, OSE Immunotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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