CC-93538 for Eosinophilic Esophagitis

Recruiting in Palo Alto (17 mi)

+393 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Celgene

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial aims to evaluate the ongoing safety and tolerability of CC-93538 in participants who were part of earlier studies involving this treatment.

Eligibility Criteria

This trial is for adults and adolescents who have Eosinophilic Esophagitis (EoE) and were part of previous CC-93538 studies. They must not have other conditions that could affect the study, no severe allergies to ingredients in CC-93538, no recent immunotherapy or live vaccines, and women must test negative for pregnancy and use contraception.

Inclusion Criteria

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.

I am not pregnant and agree to use effective birth control during and for 5 months after treatment.

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Exclusion Criteria

I have not taken any immune-weakening drugs recently.

I haven't taken any experimental drugs recently, except for those in specific studies.

I do not have any health conditions that could interfere with the study or increase my risk by participating.

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Treatment Details

Interventions

CC-93538 (Unknown)

Trial OverviewThe trial tests the long-term safety of a drug called CC-93538 in patients with EoE who participated in earlier related trials. It's an open-label study, meaning everyone knows they're getting the drug, without a comparison group.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Administration of CC-93538Experimental Treatment1 Intervention

Participants are administered CC-93538 dose subcutaneously once weekly