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Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

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: NCT04991935
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: CC-93538 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 259 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Multinational, Open-Label Extension Study to Evaluate the Long-Term Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis
Actual Study Start Date : September 14, 2021
Estimated Primary Completion Date : September 17, 2026
Estimated Study Completion Date : September 17, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Administration of CC-93538
Participants are administered CC-93538 dose subcutaneously once weekly
 Drug: CC-93538
CC-93538
Other Names:
  • BMS-986355
  • cendakimab


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: For a minimum of 28 months ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.


Secondary Outcome Measures :
  1. Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies [ Time Frame: For a minimum of 28 months ]
    This includes neutralizing antibodies when warranted.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously participated in prior clinical study CC-93538-EE-001 and either:

    1. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR
    2. Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
    3. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR
    4. Subject completed Week 48 of the Maintenance Phase
  • OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments through the end of treatment visit
  • Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies.
  • Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the Investigator.
  • Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.

Exclusion Criteria:

  • Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.
  • Active Helicobacter pylori infection or esophageal varices.
  • Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.
  • Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study.
  • Received an investigational product, other than that administered in the CC-93538-EE-001 or CC-93538-DDI-001 studies, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during the CC-93538-EE-001 or CC-93538-DDI-001 studies are not eligible to participate, unless allowed following a discussion with the Clinical Trial Physician.
  • Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study.
  • Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the participant's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality).
  • Active parasitic/helminthic infection or a suspected parasitic/helminthic infections or chronic infection (viral hepatitis, tuberculosis, or HIV)
  • Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538.
  • Females who are pregnant or lactating.
Contacts and Locations
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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): NCT04991935


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04991935    
Other Study ID Numbers: CC-93538-EE-002
2020-004335-24 ( EudraCT Number )
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Eosinophilic Esophagitis
CC-93538
RPC4046
Adult
Adolescent
Gastrointestinal Diseases
Esophagitis
Gastroenteritis
Eosinophils
 Eosinophilia
Esophageal Diseases
Allergic Diseases
Antibody, Monoclonal
Hypersensitivity
Immunologic factors
Physiological Effects of Drugs
Cendakimab
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases