CompletedPhase 3

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

United States367 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 range12 Years – 75 Years

SexALL

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)

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 range12 Years – 75 Years

SexALL

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)