Trial · NCT05214768
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
NCT05214768, Phase 3, Completed, Celgene; results first posted 2025-09-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis. Trials, record NCT05214768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05214768
On this page
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 Japanese Participants With Eosinophilic Gastroenteritis
- NCT number
- NCT05214768
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 48 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Eosinophilic Gastroenteritis
- Interventions
- CC-93538, Placebo
- First posted
- 2022-01-31
- Last updated
- 2026-09-14
- Results first posted
- 2025-09-18
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies | Baseline and Week 16 | Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. |
| Secondary | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Baseline and Week 16 | The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. |
| Secondary | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Baseline and Week 48 | The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. |
| Secondary | Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16 | Week 16 | Clinical response defined as percentage of participants who achieve \<4/15 in each of three Symptoms of Interest (Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain) scores of Izumo Scale from baseline. Histologic response defined as a \> 75% reduction of peak gastric and/or duodenal eos count from baseline. Izumo Scale tests 5 different GI symptom domains during past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Ques1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Ques7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Ques13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and score for each question within a domain added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. |
| Secondary | Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48 | Baseline and week 48 | Clinical response defined as percentage of participants who achieve \<4/15 in each of three Symptoms of Interest (Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain) scores of Izumo Scale from baseline. Histologic response defined as a \> 75% reduction of peak gastric and/or duodenal eos count from baseline. Izumo Scale tests 5 different GI symptom domains during past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Ques1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Ques7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Ques13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and score for each question within a domain added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. |
| Secondary | Induction + Maintenance: Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies at Week 48 | Baseline and Week 48 | Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm |
| Secondary | Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | Baseline and Week 16 | Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. |
| Secondary | Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | Baseline and Week 48 | Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. |
| Secondary | Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | Week 16 | Histologic response defined as a \> 75% reduction of peak gastric and/or duodenal eos count from baseline. |
| Secondary | Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | Week 48 | Histologic response defined as a \> 75% reduction of peak gastric and/or duodenal eos count from baseline. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
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 Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies | Baseline and Week 16 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. | Peak # of eosinophils counted per field | LEAST_SQUARES_MEAN |
| SECONDARY | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Baseline and Week 16 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Baseline and Week 48 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16 | Week 16 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). | percentage of participants | NUMBER |
| SECONDARY | Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48 | Baseline and week 48 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. | percentage of participants | NUMBER |
| SECONDARY | Induction + Maintenance: Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies at Week 48 | Baseline and Week 48 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants with baseline measurements of peak eos analyzed at specified timepoint are included in the analysis. | Peak # of eosinophils counted per field | LEAST_SQUARES_MEAN |
| SECONDARY | Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | Baseline and Week 16 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | Baseline and Week 48 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants with baseline measurements of peak eos analyzed at specified timepoint are included in the analysis. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | Week 16 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). | percentage of participants | NUMBER |
| SECONDARY | Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | Week 48 | Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. | percentage of participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group111
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 Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies | CC-93538 360 mg QW | -100.4 | Standard Error 44.23 | Peak # of eosinophils counted per field | |
| Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies | Placebo | 122.8 | Standard Error 60.27 | Peak # of eosinophils counted per field | |
| Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | CC-93538 360 mg QW | Heartburn Symptoms domain | -1.9 | Standard Error 0.46 | Score on a Scale |
| Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Placebo | Heartburn Symptoms domain | -1.7 | Standard Error 0.66 | Score on a Scale |
| Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | CC-93538 360 mg QW | Gastric Pain Symptoms domain | -2.1 | Standard Error 0.60 | Score on a Scale |
| Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Placebo | Gastric Pain Symptoms domain | -0.9 | Standard Error 0.86 | Score on a Scale |
| Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | CC-93538 360 mg QW | Stomach Heaviness Symptoms domain | -2.1 | Standard Error 0.61 | Score on a Scale |
| Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Placebo | Stomach Heaviness Symptoms domain | -2.2 | Standard Error 0.87 | Score on a Scale |
| Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | CC-93538 360 mg QW | Constipation Symptoms domain | -1.0 | Standard Error 0.49 | Score on a Scale |
| Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Placebo | Constipation Symptoms domain | -0.9 | Standard Error 0.69 | Score on a Scale |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | Induction Phase - CC-93538 360 mg QW | 32 | |
| Induction Period | STARTED | Induction Phase - Placebo | 16 | |
| Induction Period | STARTED | Maintenance Phase - CC-93538 360 mg QW | 0 | |
| Induction Period | STARTED | Maintenance Phase - CC-93538 360 QW/Q2W | 0 | |
| Induction Period | STARTED | Maintenance Phase - Placebo | 0 | |
| Induction Period | STARTED | Open-Label Extension - CC-93538 360 mg QW | 0 | |
| Induction Period | COMPLETED | Induction Phase - CC-93538 360 mg QW | 30 | |
| Induction Period | COMPLETED | Induction Phase - Placebo | 16 | |
| Induction Period | COMPLETED | Maintenance Phase - CC-93538 360 mg QW | 0 | |
| Induction Period | COMPLETED | Maintenance Phase - CC-93538 360 QW/Q2W | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events360
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Induction and Maintenance - CC-93538 360mg QW | 0 | 20 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Maintenance - CC-93538 360mg QW/Q2W | 0 | 12 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Induction and Maintenance - Placebo | 1 | 16 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Open-label Long-term Extension Phase - CC-93538 360mg QW | 1 | 44 | |
| other | Cataract | Eye disorders | Induction and Maintenance - CC-93538 360mg QW | 1 | 20 | |
| other | Cataract | Eye disorders | Maintenance - CC-93538 360mg QW/Q2W | 0 | 12 | |
| other | Cataract | Eye disorders | Induction and Maintenance - Placebo | 1 | 16 | |
| other | Cataract | Eye disorders | Open-label Long-term Extension Phase - CC-93538 360mg QW | 0 | 44 | |
| other | Conjunctivitis allergic | Eye disorders | Induction and Maintenance - CC-93538 360mg QW | 0 | 20 | |
| other | Conjunctivitis allergic | Eye disorders | Maintenance - CC-93538 360mg QW/Q2W | 1 | 12 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction and Maintenance - CC-93538 360mg QW | 0 | 20 |
| Total, all-cause mortality | Maintenance - CC-93538 360mg QW/Q2W | 0 | 12 |
| Total, all-cause mortality | Induction and Maintenance - Placebo | 0 | 16 |
| Total, all-cause mortality | Open-label Long-term Extension Phase - CC-93538 360mg QW | 0 | 44 |
| Total, other adverse events | Induction and Maintenance - CC-93538 360mg QW | 16 | 20 |
| Total, other adverse events | Maintenance - CC-93538 360mg QW/Q2W | 9 | 12 |
| Total, other adverse events | Induction and Maintenance - Placebo | 13 | 16 |
| Total, other adverse events | Open-label Long-term Extension Phase - CC-93538 360mg QW | 30 | 44 |
| Total, serious adverse events | Induction and Maintenance - CC-93538 360mg QW | 0 | 20 |
| Total, serious adverse events | Maintenance - CC-93538 360mg QW/Q2W | 1 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CC-93538 360 mg QW vs CC-93538 360 QW/Q2W: Induction and Maintenance: Number of Participants With Anti-Drug-Antibody |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05214768
GET https://conductscience.org/api/trials/v1/NCT05214768/registered?page=2