University of Nebraska Medical Center | Cardiovascular Department
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About
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase.
Participants will be randomized at the beginning of the study into 3 treatment arms:
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Inclusion criteria
Participants must satisfy the following criteria to be enrolled in the study:
3 Participant-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening.
Lack of complete response to an adequate trial of proton pump inhibitor (8 weeks). Participants on a proton pump inhibitor must have been on a stable dose for at least 4 weeks prior to first Screening Visit and agree to continue the same dose throughout the study.
Participants currently receiving inhaled corticosteroids, leukotriene receptor antagonists, or mast cell stabilizers for indications other than EoE, or medium potency topical corticosteroids for dermatologic conditions, must maintain stable doses for at least 4 weeks prior to the first Screening Visit and throughout the duration of the study.
Participants must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or eosinophilic esophagitis) and not introduce any changes in their diet from the first Screening Visit to the end of the study.
Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose.
Exclusion criteria
The presence of any of the following will exclude a participant from enrollment:
Primary purpose
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430 participants in 3 patient groups, including a placebo group
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Central trial contact
First line of the email MUST contain the NCT# and Site #; BMS Study Connect Contact Center www.BMSStudyConnect.com
Data sourced from clinicaltrials.gov
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