A Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Long-term Controlled Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.

  • STATUS
    Recruiting
  • End date
    Aug 21, 2024
  • participants needed
    399
  • sponsor
    Celgene
Updated on 27 October 2022
Investigator
BMS Study Connect Contact Center www.BMSStudyConnect.com
Primary Contact
Local Institution - 201 (2.9 mi away) Contact
+226 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 on27 October 2022

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
Prior treatment with CC-93538 during a Phase 1 or 2 clinical study
systemic corticosteroid within 8 weeks of the first Screening Visit
Receipt of a live attenuated vaccine within 4 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
Females who are pregnant or lactating
and during the study
Actively successful dietary modification adherence (e.g. food elimination diet)
resulting in a complete response to EoE
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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