Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04991935 · ClinicalTrials.gov registry record · Phase 3
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
A Phase 3 study of Eosinophilic Esophagitis, sponsored by Celgene.
- Active
- Registry status
- Phase 3
- Development phase
- 368
- Enrollment target
- 20
- Study locations
NCT04991935: Active Phase 3 study of Eosinophilic Esophagitis, sponsored by Celgene.
NCT04991935 is a Phase 3 study of Eosinophilic Esophagitis that is active but no longer recruiting, run by Celgene. The registered enrollment target is 368 participants, below the 856-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04991935, a Phase 3 study of Eosinophilic Esophagitis, is active but no longer recruiting, sponsored by Celgene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 368 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
Conditions Studied
Interventions
- DRUG CC-93538
Study Locations (20)
Florida
- Local Institution - 099 - Clearwater
- Local Institution - 036 - Inverness
- Local Institution - 042 - Jacksonville
- Local Institution - 138 - Miami
- Local Institution - 146 - Orlando
Arizona
- Local Institution - 082 - Phoenix
- Local Institution - 147 - Phoenix
- Local Institution - 041 - Scottsdale
- Local Institution - 029 - Tucson
California
- Local Institution - 075 - Lancaster
- Local Institution - 047 - Los Angeles
- Local Institution - 160 - San Diego
Colorado
- Local Institution - 068 - Aurora
- Local Institution - 067 - Colorado Springs
- Local Institution - 128 - Wheat Ridge
Connecticut
- Local Institution - 101 - Bristol
- Local Institution - 076 - Farmington
- Local Institution - 156 - Hamden
Alabama
- Local Institution - 144 - Birmingham
Arkansas
- Local Institution - 165 - North Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2026-09-29 |
| Phase | Phase 3 |
What the registry record for NCT04991935 still lists
NCT04991935 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 856-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 1 intervention - of which CC-93538 is the first listed.
NCT04991935 names 20 study sites across 7 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04991935 about?
NCT04991935 is a clinical study titled "Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis". 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.
What is the current status of trial NCT04991935?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 368 participants. The study started on 2021-09-14. Estimated completion is 2026-09-29.
What conditions does trial NCT04991935 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis.
What interventions are being tested in trial NCT04991935?
The interventions under investigation include: CC-93538 (DRUG).
Who is sponsoring clinical trial NCT04991935?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04991935 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Eosinophilic Esophagitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04991935's enrollment target sits among peer trials
368 9th of 44 higher than 35 of 44 other Eosinophilic Esophagitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
RECRUITING · Phase 3
-
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
ACTIVE NOT RECRUITING · Phase 3
-
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
COMPLETED · Phase 3
-
Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
COMPLETED · Phase 3
-
Characteristics and Inflammatory Markers in Children with Eosinophilic Esophagitis (EoE)
RECRUITING
-
Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04675476 · 368 participants · NA
A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening
- NCT05215353 · 368 participants · Phase 4
A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
- NCT06182397 · 368 participants · NA
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
- NCT06629610 · 368 participants · NA
Diet and Active Lifestyle - Yuuyaraq (The Yup'ik Way of Life)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI