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
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
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.
Inclusion Criteria:
Previously participated in prior clinical study CC-93538-EE-001 and either:
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:
Maroorchydore, Queensland 4558, Australia
Western Australia, 6056, Australia
Burgenland, 7000, Austria
West-Vlaanderen, 8310, Belgium
Bunkyo-ku, Tokyo 113-8603, Japan
Setagaya-ku, Tokyo 157-8535, Japan
Isehara City, Kanagawa, 259-1193, Japan
Shinjuku-Ku, 162-8655, Japan
Lódz, 90-127, Poland
Belfast Northern Ireland, BT9 7AB, United Kingdom
Hexam, NE46 1QJ, United Kingdom