Trial · NCT04753697
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
NCT04753697, Phase 3, Completed, Celgene; results first posted 2025-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis. Trials, record NCT04753697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04753697
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
- NCT number
- NCT04753697
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 430 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Eosinophilic Esophagitis
- Interventions
- CC-93538, Placebo
- First posted
- 2021-02-15
- Last updated
- 2025-03-13
- Other registries' IDs
- eudract:2020-004336-16
- Results first posted
- 2025-03-13
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Dysphagia Days (DD) at Week 24 | Baseline (Day 1) and Week 24 | Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period. |
| Primary | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24 | Week 24 | Blood samples were collected to assess esophageal eosinophil count. |
| Secondary | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | Week 48 | Blood samples were collected to assess esophageal eosinophil count. |
| Secondary | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24 | Week 24 | Blood samples were collected to assess esophageal eosinophil count. |
| Secondary | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48 | Week 48 | Blood samples were collected to assess esophageal eosinophil count. |
| Secondary | Change From Baseline in Mean Dysphagia Days (DD) at Week 48 | Baseline (Day 1) and Week 48 | Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period. |
| Secondary | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24 | Baseline (Day 1) , Week 24 | The EREFS, measures features of EoE including esophageal edema, fixed rings, exudates, furrows, and strictures. The instrument grades edema as none (0) or present (1) or severe; furrows as absent (0), present (1); rings as none (0), mild (1), moderate (2) and severe (3); exudates as none (0), mild (1) or severe (2); and strictures as absent (0) or present (1). Two sub-component scores will be calculated by adding up the grade from respective features across the 3 esophagus levels (proximal, mid, and distal). Inflammation composite score (ranging 0 to 12) includes edema, furrows and exudates while remodeling composite score (0 to 12) consist of stricture and fixed rings. The EREFS total score is the sum of the inflammation and remodeling composite scores. The EREFS total score ranges from 0 to 24. High score signifies severe condition. |
| Secondary | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48 | Baseline (Day 1) , Week 48 | The EREFS, measures features of EoE including esophageal edema, fixed rings, exudates, furrows, and strictures. The instrument grades edema as none (0) or present (1) or severe; furrows as absent (0), present (1); rings as none (0), mild (1), moderate (2) and severe (3); exudates as none (0), mild (1) or severe (2); and strictures as absent (0) or present (1). Two sub-component scores will be calculated by adding up the grade from respective features across the 3 esophagus levels (proximal, mid, and distal). Inflammation composite score (ranging 0 to 12) includes edema, furrows and exudates while remodeling composite score (0 to 12) consist of stricture and fixed rings. The EREFS total score is the sum of the inflammation and remodeling composite scores. The EREFS total score ranges from 0 to 24. High score signifies severe condition. |
| Secondary | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24 | Baseline (Day 1), Week 24 | EoEHSS evaluates the grade (severity) of multiple pathologic features in esophageal biopsies. It has 8 features eosinophil inflammation, basal zone hyperplasia, eosinophil abscess, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. In 3 separate esophagus levels (proximal, mid, and distal), each feature is scored independently for grade using a 4-point Likert scale (0 \[absent\] to 3 \[severe\]). The mean adjusted grade score is calculated by averaging the adjusted scores for the 3 levels (proximal, mid, and distal). The mean adjusted scores range from 0 to 100. High score signifies severe condition. |
| Secondary | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48 | Baseline (Day 1) , Week 48 | EoEHSS evaluates the grade (severity) of multiple pathologic features in esophageal biopsies. It has 8 features eosinophil inflammation, basal zone hyperplasia, eosinophil abscess, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. In 3 separate esophagus levels (proximal, mid, and distal), each feature is scored independently for grade using a 4-point Likert scale (0 \[absent\] to 3 \[severe\]). The mean adjusted grade score is calculated by averaging the adjusted scores for the 3 levels (proximal, mid, and distal). The mean adjusted scores range from 0 to 100. High score signifies severe condition. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Dysphagia Days (DD) at Week 24 | Baseline (Day 1) and Week 24 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | days | MEAN |
| PRIMARY | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24 | Week 24 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | Week 48 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24 | Week 24 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48 | Week 48 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Dysphagia Days (DD) at Week 48 | Baseline (Day 1) and Week 48 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | days | MEAN |
| SECONDARY | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24 | Baseline (Day 1) , Week 24 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48 | Baseline (Day 1) , Week 48 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24 | Baseline (Day 1), Week 24 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48 | Baseline (Day 1) , Week 48 | The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis. | score on a scale | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group1,378
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Dysphagia Days (DD) at Week 24 | Induction Phase - CC-93538 360 mg QW | -6.85 | Standard Deviation 5.259 | days | |
| Change From Baseline in Mean Dysphagia Days (DD) at Week 24 | Induction Phase - Placebo | -4.98 | Standard Deviation 5.075 | days | |
| Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24 | Induction Phase - CC-93538 360 mg QW | 34.1 | percentage of participants | ||
| Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24 | Induction Phase - Placebo | 3.1 | percentage of participants | ||
| Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | Maintenance Phase - CC-93538 360 mg QW | 37.5 | percentage of participants | ||
| Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | Maintenance Phase - CC-93538 360 mg Q2W | 34.3 | percentage of participants | ||
| Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | Maintenance Phase - Placebo | 4.9 | percentage of participants | ||
| Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24 | Induction Phase - CC-93538 360 mg QW | 53.0 | percentage of participants | ||
| Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24 | Induction Phase - Placebo | 4.7 | percentage of participants | ||
| Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48 | Maintenance Phase - CC-93538 360 mg QW | 50.0 | percentage of participants |
1 to 10 of 1,378Source ClinicalTrials.gov
See all 1,378 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment Period | STARTED | CC-93538 360 mg QW | 143 | |
| Pre-Treatment Period | STARTED | CC-93538 360 mg QW/Q2W | 143 | |
| Pre-Treatment Period | STARTED | Placebo | 144 | |
| Pre-Treatment Period | COMPLETED | CC-93538 360 mg QW | 143 | |
| Pre-Treatment Period | COMPLETED | CC-93538 360 mg QW/Q2W | 141 | |
| Pre-Treatment Period | COMPLETED | Placebo | 143 | |
| Pre-Treatment Period | NOT COMPLETED | CC-93538 360 mg QW | 0 | |
| Pre-Treatment Period | NOT COMPLETED | CC-93538 360 mg QW/Q2W | 2 | |
| Pre-Treatment Period | NOT COMPLETED | Placebo | 1 | |
| Induction Phase | STARTED | CC-93538 360 mg QW | 143 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events93
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | CC-93538 360 mg QW | 7 | 167 | |
| other | Abdominal pain | Gastrointestinal disorders | CC-93538 360 mg Q2W | 6 | 117 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 5 | 143 | |
| other | Diarrhoea | Gastrointestinal disorders | CC-93538 360 mg QW | 8 | 167 | |
| other | Diarrhoea | Gastrointestinal disorders | CC-93538 360 mg Q2W | 8 | 117 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 9 | 143 | |
| other | Nausea | Gastrointestinal disorders | CC-93538 360 mg QW | 11 | 167 | |
| other | Nausea | Gastrointestinal disorders | CC-93538 360 mg Q2W | 6 | 117 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 143 | |
| other | Vomiting | Gastrointestinal disorders | CC-93538 360 mg QW | 6 | 167 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CC-93538 360 mg QW | 0 | 167 |
| Total, all-cause mortality | CC-93538 360 mg Q2W | 0 | 117 |
| Total, all-cause mortality | Placebo | 0 | 143 |
| Total, other adverse events | CC-93538 360 mg QW | 103 | 167 |
| Total, other adverse events | CC-93538 360 mg Q2W | 73 | 117 |
| Total, other adverse events | Placebo | 69 | 143 |
| Total, serious adverse events | CC-93538 360 mg QW | 4 | 167 |
| Total, serious adverse events | CC-93538 360 mg Q2W | 4 | 117 |
| Total, serious adverse events | Placebo | 8 | 143 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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