Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis (CoTikiS)
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ClinicalTrials.gov Identifier: NCT04882007 |
Recruitment Status : Unknown
Verified June 2021 by OSE Immunotherapeutics.
Recruitment status was: Recruiting
First Posted : May 11, 2021
Last Update Posted : June 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: OSE-127 Drug: Placebo | Phase 2 |
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 |
Arm | Intervention/treatment |
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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
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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
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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
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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
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Drug: OSE-127
mAb antagonist to CD127 receptor (or IL-7Rα) |
- 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
- 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
- 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
- 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
- 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
- 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)
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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,
- a stool frequency score ≥ 1 (sub-score calculated before bowel preparation), and
- an endoscopic sub-score ≥ 2
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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
Exclusion Criteria:
- 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
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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
- 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)
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
Contact: Caroline Chevalier | +33 630 842 002 | caroline.chevalier@ose-immuno.com |
Study Director: | Frederique Corallo, MD | OSE Immunotherapeutics |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ulcerative colitis inflammatory bowel diseases Auto-Immune Diseases CD127/IL-7Rα Antagonist |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |