A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis
- Conditions
- Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]EOSINOPHILIC ESOPHAGITISMedDRA version: 20.1Level: LLTClassification code 10064220Term: Eosinophilic esophagitisSystem Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2020-004335-24-AT
- Lead Sponsor
- Celgene International II Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 269
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-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-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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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