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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04882007
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
OSE Immunotherapeutics

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: OSE-127 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: During the Double-blind phase all participants will be blinded to treatment assignment.
Primary Purpose: Treatment
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)
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882007


Contacts
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Contact: Caroline Chevalier +33 630 842 002 caroline.chevalier@ose-immuno.com

Locations
Show Show 55 study locations
Sponsors and Collaborators
OSE Immunotherapeutics
Investigators
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Study Director: Frederique Corallo, MD OSE Immunotherapeutics
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Responsible Party: OSE Immunotherapeutics
ClinicalTrials.gov Identifier: NCT04882007    
Other Study ID Numbers: OSE-127-C201
2020-001398-59 ( EudraCT Number )
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OSE Immunotherapeutics:
ulcerative colitis
inflammatory bowel diseases
Auto-Immune Diseases
CD127/IL-7Rα Antagonist
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases