Eosinophilic Gastroenteritis
Conditions
Keywords
Eosinophilic Gastroenteritis, CC-93538, Gastrointestinal Diseases, Eosinophilic Gastro-Intestinal Disorder, EGID, Digestive system diseases, Gastroenteritis
Brief summary
The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.
Interventions
DRUGCC-93538
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologic evidence of eosinophilic gastroenteritis (EGE) defined as ≥ 30 eosinophils (eos)/high-power field (hpf) in at least 5 hpf in the stomach and/or ≥ 30 eos/hpf in at least 3 hpf in the duodenum while on stable background therapy for EGE * Has weekly symptom scores of ≥ 4/15 for any of Gastric Pain Symptoms domain, Stomach Heaviness Symptom domains, and /or Diarrhea Symptoms domain as assessed by the Izumo Scale with electronic device for the 2 consecutive weeks before Day 1 * Must agree to maintain a stable diet from the first Screening Visit and throughout the duration of the study, and participants must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit * Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose
Exclusion criteria
* Ascites requiring treatment or symptomatic ascites * History of inflammatory bowel disease, achalasia or esophageal surgery * Has other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 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. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest. |
| Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 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 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. |
| Induction Phase: Changes in Total Score of Eosinophilic Gastrointestinal Disorder (EGID) Severity Score From Baseline to Weeks 16 in Adolescent (12 to 19 Years) | Baseline and Week 16 | 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. |
| Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years) | Baseline and Week 16 | 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. |
| Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years) | Baseline and Week 48 | 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. |
| Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years) | Baseline and Week 48 | 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. |
| Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | Through Week 16 | 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). |
| Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | Through Week 48 | 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. |
| Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use | From Week 16 through Week 48 | Participants who use concomitant corticosteroid at baseline and entered Maintenance Phase |
| Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 24, 32, 40 and 48 | Participants who use concomitant corticosteroid at baseline and entered Maintenance period were included in the analysis. |
| Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | From Day 1 untill Week 48 | 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. |
| Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements | From Day 1 untill Week 48 | Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. |
| Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters | From Day 1 untill Week 48 | Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. |
| 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 | From Day 1 untill Week 48 | Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. |
| Induction and Maintenance: Number of Participants With Anti-Drug-Antibody | From Day 1 till Week 48 | 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. |
| Induction Phase: CC-93538 Trough Concentration at Week 16 | Week 16 | Blood samples were collected to assess CC-93538 trough concentrations. |
| Maintenance Phase: CC-93538 Trough Concentration at Week 48 | 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. |
Countries
Japan
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CC-93538 360 mg QW Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase. | 32 |
| Placebo Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase. | 16 |
| Total | 48 |
Baseline characteristics
| Characteristic | Placebo | Total | CC-93538 360 mg QW |
|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 17.63 | 41.2 years STANDARD_DEVIATION 16.9 | 40.8 years STANDARD_DEVIATION 16.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 48 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 48 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 20 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 28 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 12 | 0 / 16 | 0 / 44 |
| other Total, other adverse events | 16 / 20 | 9 / 12 | 13 / 16 | 39 / 44 |
| serious Total, serious adverse events | 0 / 20 | 1 / 12 | 0 / 16 | 7 / 44 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies | -100.4 Peak # of eosinophils counted per field | Standard Error 44.23 |
| Placebo | Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies | 122.8 Peak # of eosinophils counted per field | Standard Error 60.27 |
p-value: 0.00395% CI: [-370.2, -76.3]ANCOVA
Secondary
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
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CC-93538 360 mg QW | Induction and Maintenance: Number of Participants With Anti-Drug-Antibody | 2 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Anti-Drug-Antibody | 0 Participants |
Secondary
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
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CC-93538 360 mg QW | 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 Participants |
| 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 Participants |
| 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 Participants |
Secondary
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
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CC-93538 360 mg QW | Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters | 0 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters | 0 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters | 0 Participants |
Secondary
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
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CC-93538 360 mg QW | Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements | 0 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements | 0 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements | 0 Participants |
Secondary
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
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-93538 360 mg QW | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any TEAEs | 16 Participants |
| CC-93538 360 mg QW | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any Serious TEAEs | 0 Participants |
| CC-93538 360 mg QW | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any Moderate or Severe TEAE | 10 Participants |
| CC-93538 360 mg QW | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | ANY TEAE suspected to be related to study drug | 6 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | ANY TEAE suspected to be related to study drug | 3 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any TEAEs | 9 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any Moderate or Severe TEAE | 6 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any Serious TEAEs | 1 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | ANY TEAE suspected to be related to study drug | 2 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any Serious TEAEs | 0 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any Moderate or Severe TEAE | 10 Participants |
| Placebo | Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events | Any TEAEs | 13 Participants |
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
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | 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 Peak # of eosinophils counted per field | Standard Error 61.26 |
| 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 | -151.2 Peak # of eosinophils counted per field | Standard Error 89.7 |
| 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 | 98.6 Peak # of eosinophils counted per field | Standard Error 66.03 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CC-93538 360 mg QW | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Constipation Symptoms domain | 0.6 Score on a Scale | Standard Error 0.79 |
| CC-93538 360 mg QW | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Stomach Heaviness Symptoms domain | 0.7 Score on a Scale | Standard Error 0.81 |
| CC-93538 360 mg QW | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Heartburn Symptoms domain | 0.2 Score on a Scale | Standard Error 0.74 |
| CC-93538 360 mg QW | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Gastric Pain Symptoms domain | 0.1 Score on a Scale | Standard Error 0.81 |
| CC-93538 360 mg QW | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Diarrhea Symptoms domain | 1.5 Score on a Scale | Standard Error 0.87 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Stomach Heaviness Symptoms domain | -3.4 Score on a Scale | Standard Error 1.05 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Heartburn Symptoms domain | -2.0 Score on a Scale | Standard Error 0.98 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Gastric Pain Symptoms domain | -2.5 Score on a Scale | Standard Error 1.08 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Constipation Symptoms domain | -1.0 Score on a Scale | Standard Error 1.07 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Diarrhea Symptoms domain | -0.1 Score on a Scale | Standard Error 1.16 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Diarrhea Symptoms domain | -2.3 Score on a Scale | Standard Error 0.97 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Constipation Symptoms domain | -1.4 Score on a Scale | Standard Error 0.85 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Heartburn Symptoms domain | -1.4 Score on a Scale | Standard Error 0.84 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Stomach Heaviness Symptoms domain | -1.5 Score on a Scale | Standard Error 0.9 |
| Placebo | Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 | Gastric Pain Symptoms domain | -1.8 Score on a Scale | Standard Error 0.91 |
Secondary
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
Population: 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. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years) | 7.1 Score on a Scale | Standard Error 0 |
| Placebo | Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years) | -10.4 Score on a Scale | Standard Error 0 |
| Placebo | Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years) | 1.7 Score on a Scale | Standard Error 0 |
Secondary
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
Population: 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. Only participants from ages \>=20 years old at specified timepoint are included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years) | -3.3 Score on a Scale | Standard Error 2.76 |
| Placebo | Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years) | -2.4 Score on a Scale | Standard Error 5.32 |
| Placebo | Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years) | -7.2 Score on a Scale | Standard Error 3.35 |
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-93538 360 mg QW | Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 10.0 percentage of participants |
| Placebo | Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 25.0 percentage of participants |
| Placebo | Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 31.3 percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-93538 360 mg QW | Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48 | 0 percentage of participants |
| Placebo | Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48 | 8.3 percentage of participants |
| Placebo | Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48 | 0 percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-93538 360 mg QW | Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | 0 percentage of participants |
| Placebo | Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | 25.0 percentage of participants |
| Placebo | Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | 0 percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | 7.2 Percent change | Standard Error 29.78 |
| Placebo | Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | -39.9 Percent change | Standard Error 50.54 |
| Placebo | Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | 43.7 Percent change | Standard Error 36.15 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CC-93538 360 mg QW | Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | EGE Flare | NA days |
| CC-93538 360 mg QW | Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | Use of rescue therapy | NA days |
| Placebo | Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | EGE Flare | NA days |
| Placebo | Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | Use of rescue therapy | NA days |
| Placebo | Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | EGE Flare | NA days |
| Placebo | Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | Use of rescue therapy | NA days |
Secondary
Induction Phase: CC-93538 Trough Concentration at Week 16
Blood samples were collected to assess CC-93538 trough concentrations.
Time frame: Week 16
Population: Pharmacokinetic population included all participants who received at least one dose of active drug and have at least one measurable concentration data. Only participants with data available at specified timepoint and receiving CC-93538 were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | Induction Phase: CC-93538 Trough Concentration at Week 16 | 179472.2 ng/mL | Geometric Coefficient of Variation 47.2 |
Secondary
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
Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CC-93538 360 mg QW | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Gastric Pain Symptoms domain | -2.1 Score on a Scale | Standard Error 0.6 |
| CC-93538 360 mg QW | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Constipation Symptoms domain | -1.0 Score on a Scale | Standard Error 0.49 |
| CC-93538 360 mg QW | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Stomach Heaviness Symptoms domain | -2.1 Score on a Scale | Standard Error 0.61 |
| CC-93538 360 mg QW | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Diarrhea Symptoms domain | -1.8 Score on a Scale | Standard Error 0.46 |
| CC-93538 360 mg QW | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Heartburn Symptoms domain | -1.9 Score on a Scale | Standard Error 0.46 |
| Placebo | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Diarrhea Symptoms domain | -1.6 Score on a Scale | Standard Error 0.65 |
| Placebo | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Heartburn Symptoms domain | -1.7 Score on a Scale | Standard Error 0.66 |
| Placebo | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Gastric Pain Symptoms domain | -0.9 Score on a Scale | Standard Error 0.86 |
| Placebo | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Stomach Heaviness Symptoms domain | -2.2 Score on a Scale | Standard Error 0.87 |
| Placebo | Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 | Constipation Symptoms domain | -0.9 Score on a Scale | Standard Error 0.69 |
Secondary
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
Population: 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 at specified timepoint are included in the analysis. Only participants from ages \>=20 years years old at specified timepoint are included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years) | -5.5 Score on a Scale | Standard Error 1.4 |
| Placebo | Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years) | -4.5 Score on a Scale | Standard Error 2.12 |
Secondary
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
Population: 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. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | 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 Score on a Scale | Standard Error 1.7 |
| 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) | -3.8 Score on a Scale | Standard Error 2.91 |
Secondary
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
Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-93538 360 mg QW | Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 28.1 percentage of participants |
| Placebo | Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale | 18.8 percentage of participants |
Secondary
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
Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-93538 360 mg QW | Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16 | 6.3 percentage of participants |
| Placebo | Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16 | 0 percentage of participants |
Secondary
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
Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-93538 360 mg QW | Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | 15.6 percentage of participants |
| Placebo | Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) | 0 percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | -13.4 Percent change | Standard Error 18.85 |
| Placebo | Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline | 61.6 Percent change | Standard Error 22.18 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CC-93538 360 mg QW | Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | EGE Flare | NA days |
| CC-93538 360 mg QW | Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | Use of rescue therapy | NA days |
| Placebo | Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | EGE Flare | NA days |
| Placebo | Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy | Use of rescue therapy | NA days |
Secondary
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
Population: Pharmacokinetic population included all participants who received at least one dose of active drug and have at least one measurable concentration data. Only participants with data available at specified timepoint and receiving CC-93538 were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CC-93538 360 mg QW | Maintenance Phase: CC-93538 Trough Concentration at Week 48 | 165591.7 ng/mL | Geometric Coefficient of Variation 58.5 |
| Placebo | Maintenance Phase: CC-93538 Trough Concentration at Week 48 | 76433.4 ng/mL | Geometric Coefficient of Variation 64.1 |
Secondary
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
Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CC-93538 360 mg QW | Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use | NA days |
| Placebo | Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use | NA days |
| Placebo | Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use | NA days |
Secondary
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
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CC-93538 360 mg QW | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 24 | 0 percentage of participants |
| CC-93538 360 mg QW | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 32 | 0 percentage of participants |
| CC-93538 360 mg QW | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 40 | 14.3 percentage of participants |
| CC-93538 360 mg QW | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 48 | 14.3 percentage of participants |
| Placebo | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 48 | 25.0 percentage of participants |
| Placebo | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 24 | 0 percentage of participants |
| Placebo | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 40 | 0 percentage of participants |
| Placebo | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 32 | 0 percentage of participants |
| Placebo | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 48 | 0 percentage of participants |
| Placebo | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 32 | 0 percentage of participants |
| Placebo | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 40 | 0 percentage of participants |
| Placebo | Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero | Week 24 | 0 percentage of participants |