A Phase 3 interventional study of CC-93538 and Placebo in Eosinophilic Gastroenteritis, sponsored by Celgene. Completed at 25 sites in Japan. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.
28 studies on the registry are indexed under Eosinophilic enteropathy; 5 are open to participants now.
This study's enrollment of 48 is above the median of 36 across 16 interventional studies indexed under Eosinophilic enteropathy.
Browse Eosinophilic enteropathy studies →Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
First submitted after Celgene became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: CC-93538
Drug: Placebo
Specified dose on specified days
Also known as: Cendakimab, BMS-986355
Specified dose on specified days
Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies
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.
Time frame: Baseline and Week 16
Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at 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.
Time frame: Baseline and Week 16
Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at 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.
Time frame: Baseline and Week 48
Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at 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.
Time frame: Week 16
Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at 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.
Time frame: Baseline and week 48
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
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
Time frame: Baseline and Week 48
Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline
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.
Time frame: Baseline and Week 16
Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline
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.
Time frame: Baseline and Week 48
Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)
Histologic response defined as a \> 75% reduction of peak gastric and/or duodenal eos count from baseline.
Time frame: Week 16
Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)
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.
Time frame: Week 48
Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale
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. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest.
Time frame: Week 16
Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale
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 scale of "0 = No trouble at all" to "5 = Can't stand it," and one symptom domain is scored from 0 to 15, with higher values indicating greater symptom severity. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.
Time frame: Baseline and Week 48
Induction Phase: Changes in Total Score of Eosinophilic Gastrointestinal Disorder (EGID) Severity Score From Baseline to Weeks 16 in Adolescent (12 to 19 Years)
The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild.
Time frame: Baseline and Week 16
Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years)
The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild.
Time frame: Baseline and Week 16
Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years)
The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: Baseline and Week 48
Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years)
The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: Baseline and Week 48
Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy
Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline).
Time frame: Through Week 16
Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy
Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline). Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: Through Week 48
Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use
Participants who use concomitant corticosteroid at baseline and entered Maintenance Phase
Time frame: From Week 16 through Week 48
Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero
Participants who use concomitant corticosteroid at baseline and entered Maintenance period were included in the analysis.
Time frame: Week 24, 32, 40 and 48
Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events
A treatment emergent adverse event (TEAE) is any AE that emerges during treatment or Safety Follow-up Period having been absent pre-treatment or worsens in severity relative to the pretreatment state. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: From Day 1 untill Week 48
Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: From Day 1 untill Week 48
Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: From Day 1 untill Week 48
Induction and Maintenance: Number of Participants With Mean Changes Over Time That Were of Clinically Concern in Hematology Parameters, Serum Chemistry Parameters, and Urinalysis Parameters
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: From Day 1 untill Week 48
Induction and Maintenance: Number of Participants With Anti-Drug-Antibody
Blood samples were collected to assess Anti-Drug-Antibody. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: From Day 1 till Week 48
Induction Phase: CC-93538 Trough Concentration at Week 16
Blood samples were collected to assess CC-93538 trough concentrations.
Time frame: Week 16
Maintenance Phase: CC-93538 Trough Concentration at Week 48
Blood samples were collected to assess CC-93538 trough concentrations. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Time frame: Week 48
| Milestone | Induction Phase - CC-93538 360 mg QW | Induction Phase - Placebo | Maintenance Phase - CC-93538 360 mg QW | Maintenance Phase - CC-93538 360 QW/Q2W | Maintenance Phase - Placebo | Open-Label Extension - CC-93538 360 mg QW |
|---|---|---|---|---|---|---|
| Started | 32 | 16 | 0 | 0 | 0 | 0 |
| Completed | 30 | 16 | 0 | 0 | 0 | 0 |
| Not completed | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Induction Phase - CC-93538 360 mg QW | Induction Phase - Placebo | Maintenance Phase - CC-93538 360 mg QW | Maintenance Phase - CC-93538 360 QW/Q2W | Maintenance Phase - Placebo | Open-Label Extension - CC-93538 360 mg QW |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 13 | 12 | 12 | 0 |
| Completed | 0 | 0 | 11 | 10 | 11 | 0 |
| Not completed | 0 | 0 | 2 | 2 | 1 | 0 |
| Withdrew: Other reasons | 0 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 0 | 1 | 0 |
| Milestone | Induction Phase - CC-93538 360 mg QW | Induction Phase - Placebo | Maintenance Phase - CC-93538 360 mg QW | Maintenance Phase - CC-93538 360 QW/Q2W | Maintenance Phase - Placebo | Open-Label Extension - CC-93538 360 mg QW |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 44 |
| Completed | 0 | 0 | 0 | 0 | 0 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 39 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Site terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 35 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 |
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.
| Peak # of eosinophils counted per field | CC-93538 360 mg QW | Placebo |
|---|---|---|
| Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies | -100.4 ± 44.23 | 122.8 ± 60.27 |
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.
| Score on a Scale | CC-93538 360 mg QW | Placebo |
|---|---|---|
| Heartburn Symptoms domain | -1.9 ± 0.46 | -1.7 ± 0.66 |
| Gastric Pain Symptoms domain | -2.1 ± 0.60 | -0.9 ± 0.86 |
| Stomach Heaviness Symptoms domain | -2.1 ± 0.61 | -2.2 ± 0.87 |
| Constipation Symptoms domain | -1.0 ± 0.49 | -0.9 ± 0.69 |
| Diarrhea Symptoms domain | -1.8 ± 0.46 | -1.6 ± 0.65 |
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.
| Score on a Scale | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Heartburn Symptoms domain | 0.2 ± 0.74 | -2.0 ± 0.98 | -1.4 ± 0.84 |
| Gastric Pain Symptoms domain | 0.1 ± 0.81 | -2.5 ± 1.08 | -1.8 ± 0.91 |
| Stomach Heaviness Symptoms domain | 0.7 ± 0.81 | -3.4 ± 1.05 | -1.5 ± 0.90 |
| Constipation Symptoms domain | 0.6 ± 0.79 | -1.0 ± 1.07 | -1.4 ± 0.85 |
| Diarrhea Symptoms domain | 1.5 ± 0.87 | -0.1 ± 1.16 | -2.3 ± 0.97 |
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.
| percentage of participants | CC-93538 360 mg QW | Placebo |
|---|---|---|
| Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16 | 6.3 | 0 |
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.
| percentage of participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48 | 0 | 8.3 | 0 |
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
| Peak # of eosinophils counted per field | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| 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 | -24.1 ± 61.26 | -151.2 ± 89.70 | 98.6 ± 66.03 |
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.
| Percent change | CC-93538 360 mg QW | Placebo |
|---|---|---|
| Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | -13.4 ± 18.85 | 61.6 ± 22.18 |
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.
| Percent change | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | 7.2 ± 29.78 | -39.9 ± 50.54 | 43.7 ± 36.15 |
Histologic response defined as a \> 75% reduction of peak gastric and/or duodenal eos count from baseline.
| percentage of participants | CC-93538 360 mg QW | Placebo |
|---|---|---|
| Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | 15.6 | 0 |
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.
| percentage of participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | 0 | 25.0 | 0 |
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. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest.
| percentage of participants | CC-93538 360 mg QW | Placebo |
|---|---|---|
| Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 28.1 | 18.8 |
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 scale of "0 = No trouble at all" to "5 = Can't stand it," and one symptom domain is scored from 0 to 15, with higher values indicating greater symptom severity. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.
| percentage of participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 10.0 | 25.0 | 31.3 |
The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild.
| Score on a Scale | CC-93538 360 mg QW | Placebo |
|---|---|---|
| Induction Phase: Changes in Total Score of Eosinophilic Gastrointestinal Disorder (EGID) Severity Score From Baseline to Weeks 16 in Adolescent (12 to 19 Years) | -6.4 ± 1.70 | -3.8 ± 2.91 |
The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild.
| Score on a Scale | CC-93538 360 mg QW | Placebo |
|---|---|---|
| Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years) | -5.5 ± 1.40 | -4.5 ± 2.12 |
The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| Score on a Scale | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years) | 7.1 ± 0.00 | -10.4 ± 0.00 | 1.7 ± 0.00 |
The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| Score on a Scale | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years) | -3.3 ± 2.76 | -2.4 ± 5.32 | -7.2 ± 3.35 |
Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline).
| days | CC-93538 360 mg QW | Placebo |
|---|---|---|
| EGE Flare | NA (NA to NA) | NA (113 to NA) |
| Use of rescue therapy | NA (NA to NA) | NA (113 to NA) |
Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline). Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| days | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| EGE Flare | NA (92 to NA) | NA (NA to NA) | NA (113 to NA) |
| Use of rescue therapy | NA (113 to NA) | NA (NA to NA) | NA (115 to NA) |
Participants who use concomitant corticosteroid at baseline and entered Maintenance Phase
| days | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use | NA (144 to NA) | NA (176 to NA) | NA (113 to NA) |
Participants who use concomitant corticosteroid at baseline and entered Maintenance period were included in the analysis.
| percentage of participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Week 24 | 0 | 0 | 0 |
| Week 32 | 0 | 0 | 0 |
| Week 40 | 14.3 | 0 | 0 |
| Week 48 | 14.3 | 25.0 | 0 |
A treatment emergent adverse event (TEAE) is any AE that emerges during treatment or Safety Follow-up Period having been absent pre-treatment or worsens in severity relative to the pretreatment state. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| Participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Any TEAEs | 16 | 9 | 13 |
| Any Serious TEAEs | 0 | 1 | 0 |
| Any Moderate or Severe TEAE | 10 | 6 | 10 |
| ANY TEAE suspected to be related to study drug | 6 | 3 | 2 |
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| Participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements | 0 | 0 | 0 |
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| Participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters | 0 | 0 | 0 |
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| Participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W | Placebo |
|---|---|---|---|
| Induction and Maintenance: Number of Participants With Mean Changes Over Time That Were of Clinically Concern in Hematology Parameters, Serum Chemistry Parameters, and Urinalysis Parameters | 0 | 0 | 0 |
Blood samples were collected to assess Anti-Drug-Antibody. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| Participants | CC-93538 360 mg QW | CC-93538 360 QW/Q2W |
|---|---|---|
| Induction and Maintenance: Number of Participants With Anti-Drug-Antibody | 2 | 0 |
Blood samples were collected to assess CC-93538 trough concentrations.
| ng/mL | CC-93538 360 mg QW |
|---|---|
| Induction Phase: CC-93538 Trough Concentration at Week 16 | 179472.2 ± 47.2 |
Blood samples were collected to assess CC-93538 trough concentrations. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
| ng/mL | CC-93538 360 mg QW | CC-93538 360 QW/Q2W |
|---|---|---|
| Maintenance Phase: CC-93538 Trough Concentration at Week 48 | 165591.7 ± 58.5 | 76433.4 ± 64.1 |
Collected over All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 181 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Induction and Maintenance Phase - CC-93538 360mg QW | 0/20 (0%) | 0/20 (0%) | 16/20 (80%) |
| Maintenance - CC-93538 360mg QW/Q2W | 0/12 (0%) | 1/12 (8.3%) | 9/12 (75%) |
| Induction and Maintenance - Placebo | 0/16 (0%) | 0/16 (0%) | 13/16 (81.3%) |
| Open-label Long-term Extension Phase - CC-93538 360mg QW | 0/44 (0%) | 7/44 (15.9%) | 39/44 (88.6%) |
| Event | Induction and Maintenance Phase - CC-93538 360mg QW | Maintenance - CC-93538 360mg QW/Q2W | Induction and Maintenance - Placebo | Open-label Long-term Extension Phase - CC-93538 360mg QW |
|---|---|---|---|---|
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/20 | 1/12 | 0/16 | 0/44 |
| CataractEye disorders | 0/20 | 0/12 | 0/16 | 1/44 |
| GastroenteritisInfections and infestations | 0/20 | 0/12 | 0/16 | 1/44 |
| Pilonidal diseaseInfections and infestations | 0/20 | 0/12 | 0/16 | 1/44 |
| Respiratory tract infectionInfections and infestations | 0/20 | 0/12 | 0/16 | 1/44 |
| SacroiliitisMusculoskeletal and connective tissue disorders | 0/20 | 0/12 | 0/16 | 1/44 |
| TendonitisMusculoskeletal and connective tissue disorders | 0/20 | 0/12 | 0/16 | 1/44 |
| Neuroendocrine tumour of the rectumNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/20 | 0/12 | 0/16 | 1/44 |
| VaricoceleReproductive system and breast disorders | 0/20 | 0/12 | 0/16 | 1/44 |
| Event | Induction and Maintenance Phase - CC-93538 360mg QW | Maintenance - CC-93538 360mg QW/Q2W | Induction and Maintenance - Placebo | Open-label Long-term Extension Phase - CC-93538 360mg QW |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 1/20 | 6/12 | 3/16 | 10/44 |
| COVID-19Infections and infestations | 2/20 | 4/12 | 0/16 | 13/44 |
| Injection site reactionGeneral disorders and administration site conditions | 5/20 | 2/12 | 1/16 | 5/44 |
| PyrexiaGeneral disorders and administration site conditions | 0/20 | 1/12 | 4/16 | 4/44 |
| InfluenzaInfections and infestations | 1/20 | 0/12 | 1/16 | 11/44 |
| VomitingGastrointestinal disorders | 0/20 | 2/12 | 1/16 | 3/44 |
| ConstipationGastrointestinal disorders | 3/20 | 1/12 | 1/16 | 3/44 |
| BronchitisInfections and infestations | 0/20 | 0/12 | 2/16 | 2/44 |
| MigraineNervous system disorders | 0/20 | 0/12 | 2/16 | 0/44 |
| UrticariaSkin and subcutaneous tissue disorders | 1/20 | 0/12 | 0/16 | 5/44 |
| Age, Continuous(years) | CC-93538 360 mg QW | Placebo | Total |
|---|---|---|---|
| Mean | 40.8 ± 16.79 | 41.8 ± 17.63 | 41.2 ± 16.90 |
| Sex: Female, Male(Participants) | CC-93538 360 mg QW | Placebo | Total |
|---|---|---|---|
| Female | 14 | 6 | 20 |
| Male | 18 | 10 | 28 |
| Ethnicity (NIH/OMB)(Participants) | CC-93538 360 mg QW | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 32 | 16 | 48 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CC-93538 360 mg QW | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 32 | 16 | 48 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Studies of the drug tested here: Cendakimab