A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

  • STATUS
    Recruiting
  • End date
    Jul 26, 2024
  • participants needed
    399
  • sponsor
    Celgene
Updated on 26 September 2021
Investigator
Associate Director Clinical Trial Disclosure
Primary Contact
Brigham and Women's Hospital (4.5 mi away) Contact
+228 other location

Summary

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:

  • Placebo for Induction and Maintenance
  • CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance
  • CC-93538 360 mg SC once weekly for Induction and Maintenance

Details
Condition Eosinophilic esophagitis
Treatment Placebo, CC-93538
Clinical Study IdentifierNCT04753697
SponsorCelgene
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must satisfy the following criteria to be enrolled in the study
Male or female patients aged 12 and 75 years, with a body weight of > 40 kg
Histologic evidence of eosinophilic esophagitis, defined as a peak count of 15 eosinophils/high-power field at 2 levels of the esophagus
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
Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study
Other gastrointestinal disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with eosinophilic esophagitis, liver function impairment, or a known hereditary fructose intolerance
Evidence of a severe endoscopic structural abnormality in the esophagus
Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study
Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit
Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit
Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit
Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). Subcutaneous immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study
Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE
Prior treatment with CC-93538 during a Phase 1 or 2 clinical study
Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit
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. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic disorder or psychiatric illness that compromises the Participant's ability to accurately document symptoms of eosinophilic esophagitis)
Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit
Females who are pregnant or lactating
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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