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

• ClinicalTrials.gov Identifier: NCT04991935
• Recruitment Status: Recruiting
• First Posted: August 5, 2021
• Last Update Posted: May 12, 2022
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Tracking Information

• First Submitted Date: July 28, 2021
• First Posted Date: August 5, 2021
• Last Update Posted Date: May 12, 2022
• Actual Study Start Date: September 14, 2021
• Estimated Primary Completion Date: August 18, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 28, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 28, 2021)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
• Official Title: A Phase 3, Multi-Center, Multi-National, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.
• Brief Summary: This study is an open-label, uncontrolled study design to evaluate the longer-term safety profile as well as durability of response of administration of a single dose level of CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 study.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Eosinophilic Esophagitis

Intervention

Drug: CC-93538

CC-93538

Study Arms

Experimental: Administration of CC-93538

Participants are administered CC-93538 dose subcutaneously once weekly

Intervention: Drug: CC-93538

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 28, 2021): 259
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 18, 2026
• Estimated Primary Completion Date: August 18, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

  • completed both the Induction and Maintenance phases; or
  • completed the Induction Phase, however, did not qualify for the Maintenance Phase, including having a severe eosinophilic esophagitis (EoE) flare requiring endoscopic intervention or rescue therapy.
• Demonstrated compliance with required investigational product dosing during the prior study.
• Did not permanently discontinue investigational product in the prior study and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing.
• 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 CC-93538-EE-001, 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 CC-93538-EE-001 are not eligible, 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 or ongoing infections including parasitic/helminthic infections, 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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 #.

• Listed Location Countries: Argentina, Australia, Austria, Belgium, Canada, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT04991935
• Other Study ID Numbers: CC-93538-EE-002; 2020-004335-24 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Responsible Party: Celgene
• Study Sponsor: Celgene
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Celgene
• Verification Date: May 2022