CompletedPhase 3

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

United States, Argentina, Australia367 participantsStarted 2022-08-09

Plain-language summary

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.

Who can participate

Age range

12 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR
. Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR
. Subject completed Week 48 of the Maintenance Phase

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAE)

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Trial details

NCT IDNCT04991935

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-14

Results submitted2026-01-07

View on ClinicalTrials.gov More Eosinophilic Esophagitis trials

Who can participate

Age range

12 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR
. Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR
. Subject completed Week 48 of the Maintenance Phase

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAE)

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)