EUCTR2020-004335-24-PTActive, not recruitingPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 269
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •2. Demonstrated compliance with required investigational product
- •dosing during the prior Study CC-93538-EE-001 or Study CC-93538-DDI-
- •001 and subject must not have been permanently discontinued from IP
- •while participating in Study CC-93538-EE-001 or Study CC-93538-DDI-
- •3. Subjects must have not experienced any clinically significant adverse
- •events related to Investigational Product that would preclude further
- •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
- •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. Subject 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, which is clinically significant in the judgment of
- •the Investigator; colitis, celiac disease, Mendelian disorder associated
- •with EoE, or cardiovascular condition, or neurologic or psychiatric illness
- •that compromises the prospective subject's ability to accurately
- •document symptoms of EoE).
- •9. Active or ongoing infections including parasitic/helminthic infections
- •10. Subject has a chronic infection (eg, hepatitis B or C, human
- •immunodeficiency virus [HIV], or tuberculosis as defined by standard
- •medical guidelines).
Investigators
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