EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 100000004856
Conditions
Sponsors
Celgene International II Sàrl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 a. Subject must have participated in Study CC-93538-EE-001, and meets one of the following criteria: 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 b. OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments in Period 2 through Week 18/End of Treatment Visit 2. Demonstrated compliance with required investigational product dosing during the prior Study CC-93538-EE-001 or Study CC-93538-DDI001 and subject must not have been permanently discontinued from IP while participating in Study CC-93538-EE-001 or Study CC-93538-DDI-001. 3. Subjects must have not experienced any clinically significant adverse events related to Investigational Product that would preclude further dosing. 4. 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. 5. Subject (18 years of age or older) must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. For subjects less than 18 years of age, subject assent must be obtained, and parental/legal representative consent is required. Adolescent subjects who reach the legal age of consent while participating in the study will be asked to sign an ICF (called a Transitional ICF) themselves to acknowledge their willingness to continue in the study. In Austria, Germany, Spain, and Switzerland, adolescent subjects will not be enrolled. Are the trial subjects under 18? yes Number of subjects for this age range: 19 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study. 2. Subjects demonstrates presence of esophageal varices. 3. Subject has a known active Helicobacter pylori infection and/or is currently being treated for this condition 4. 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. 5. Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study. 6. Received an investigational product, other than that administered in CC-93538-EE-001 or Study CC-93538-DDI-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 or Study CC-93538-DDI-001 are not eligible, unless allowed following a discussion with the Clinical Trial Physician. 7. 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. 8. 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, a documented medical diagnosis of gastritis, while is clinically significant in the judgment of the investigator; or cardiovascular condition, or neurologic or psychiatric illness that could compromise the subject's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality). 9. Active or ongoing infections including parasitic/helminthic infections, viral hepatitis, tuberculosis, or HIV. 10. Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538. 11. Females who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of CC-93538 in subjects with eosinophilic esophagitis (EoE).;Secondary Objective: To characterize the immunogenicity profile of CC-93538 following long-term treatment.;Primary end point(s): Safety and tolerability of long-term treatment with CC-93538 evaluated by the incidence, severity, and relationship to CC-93538 of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, changes in vital signs, and physical examination abnormalities.;Timepoint(s) of evaluation of this end point: Baseline through Safety Follow-up Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies, including neutralizing antibodies when warranted.;Timepoint(s) of evaluation of this end point: Baseline through Safety Follow-up Visit | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed