Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis (NCT NCT05214768)
NCT ID: NCT05214768
Last Updated: 2025-10-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
48 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2025-10-21
Participant Flow
Participant milestones
| Measure |
Induction Phase - CC-93538 360 mg QW
Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase.
|
Induction Phase - Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase.
|
Maintenance Phase - CC-93538 360 mg QW
Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the maintenance phase.
|
Maintenance Phase - CC-93538 360 QW/Q2W
Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the maintenance phase.
|
Open-Label Extension - CC-93538 360 mg QW
Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Induction Period
STARTED
|
32
|
16
|
0
|
0
|
0
|
0
|
|
Induction Period
COMPLETED
|
30
|
16
|
0
|
0
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
STARTED
|
0
|
0
|
13
|
12
|
12
|
0
|
|
Maintenance Period
COMPLETED
|
0
|
0
|
11
|
10
|
11
|
0
|
|
Maintenance Period
NOT COMPLETED
|
0
|
0
|
2
|
2
|
1
|
0
|
|
Open Label Extension Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
44
|
|
Open Label Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open Label Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
44
|
Reasons for withdrawal
| Measure |
Induction Phase - CC-93538 360 mg QW
Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase.
|
Induction Phase - Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase.
|
Maintenance Phase - CC-93538 360 mg QW
Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the maintenance phase.
|
Maintenance Phase - CC-93538 360 QW/Q2W
Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the maintenance phase.
|
Open-Label Extension - CC-93538 360 mg QW
Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the open-label extension period.
|
|---|---|---|---|---|---|---|
|
Induction Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Other Reasons
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Period
Lack of Efficacy
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Open Label Extension Period
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open Label Extension Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open Label Extension Period
Ongoing Study
|
0
|
0
|
0
|
0
|
0
|
42
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
Baseline characteristics by cohort
| Measure |
CC-93538 360 mg QW
n=32 Participants
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.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 16.79 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 17.63 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 16.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=30 Participants
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.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
122.8 Peak # of eosinophils counted per field
Standard Error 60.27
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo).
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=32 Participants
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.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
-1.7 Score on a Scale
Standard Error 0.66
|
—
|
|
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 0.60
|
-0.9 Score on a Scale
Standard Error 0.86
|
—
|
|
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
|
-2.2 Score on a Scale
Standard Error 0.87
|
—
|
|
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
|
-0.9 Score on a Scale
Standard Error 0.69
|
—
|
|
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
|
-1.6 Score on a Scale
Standard Error 0.65
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
-2.0 Score on a Scale
Standard Error 0.98
|
-1.4 Score on a Scale
Standard Error 0.84
|
|
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
|
-2.5 Score on a Scale
Standard Error 1.08
|
-1.8 Score on a Scale
Standard Error 0.91
|
|
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
|
-3.4 Score on a Scale
Standard Error 1.05
|
-1.5 Score on a Scale
Standard Error 0.90
|
|
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
|
-1.0 Score on a Scale
Standard Error 1.07
|
-1.4 Score on a Scale
Standard Error 0.85
|
|
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
|
-0.1 Score on a Scale
Standard Error 1.16
|
-2.3 Score on a Scale
Standard Error 0.97
|
SECONDARY outcome
Timeframe: Week 16Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=32 Participants
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.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16
|
6.3 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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
Outcome measures
| Measure |
CC-93538 360 mg QW
n=19 Participants
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.
|
Placebo
n=10 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=15 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
-151.2 Peak # of eosinophils counted per field
Standard Error 89.70
|
98.6 Peak # of eosinophils counted per field
Standard Error 66.03
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=30 Participants
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.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
61.6 Percent change
Standard Error 22.18
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=19 Participants
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.
|
Placebo
n=10 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=15 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
-39.9 Percent change
Standard Error 50.54
|
43.7 Percent change
Standard Error 36.15
|
SECONDARY outcome
Timeframe: Week 16Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).
Histologic response defined as a \> 75% reduction of peak gastric and/or duodenal eos count from baseline.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=32 Participants
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.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)
|
15.6 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo).
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=32 Participants
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.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
18.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
25.0 percentage of participants
|
31.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=5 Participants
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.
|
Placebo
n=3 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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 1.70
|
-3.8 Score on a Scale
Standard Error 2.91
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=25 Participants
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.
|
Placebo
n=11 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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 1.40
|
-4.5 Score on a Scale
Standard Error 2.12
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=2 Participants
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.
|
Placebo
n=2 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=1 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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 0.00
|
-10.4 Score on a Scale
Standard Error 0.00
|
1.7 Score on a Scale
Standard Error 0.00
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=14 Participants
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.
|
Placebo
n=4 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=9 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
-2.4 Score on a Scale
Standard Error 5.32
|
-7.2 Score on a Scale
Standard Error 3.35
|
SECONDARY outcome
Timeframe: Through Week 16Population: 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.
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).
Outcome measures
| Measure |
CC-93538 360 mg QW
n=32 Participants
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.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy
EGE Flare
|
NA days
Not estimated due to insufficient number of events
|
NA days
Interval 113.0 to
Not estimated due to insufficient number of events
|
—
|
|
Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy
Use of rescue therapy
|
NA days
Not estimated due to insufficient number of events
|
NA days
Interval 113.0 to
Not estimated due to insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: Through Week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy
EGE Flare
|
NA days
Interval 92.0 to
Not estimated due to insufficient number of events
|
NA days
Not estimated due to insufficient number of events
|
NA days
Interval 113.0 to
Not estimated due to insufficient number of events
|
|
Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy
Use of rescue therapy
|
NA days
Interval 113.0 to
Not estimated due to insufficient number of events
|
NA days
Not estimated due to insufficient number of events
|
NA days
Interval 115.0 to
Not estimated due to insufficient number of events
|
SECONDARY outcome
Timeframe: From Week 16 through Week 48Population: Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).
Participants who use concomitant corticosteroid at baseline and entered Maintenance Phase
Outcome measures
| Measure |
CC-93538 360 mg QW
n=7 Participants
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.
|
Placebo
n=4 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=6 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use
|
NA days
Interval 144.0 to
Not estimated due to insufficient number of events
|
NA days
Interval 176.0 to
Not estimated due to insufficient number of events
|
NA days
Interval 113.0 to
Not estimated due to insufficient number of events
|
SECONDARY outcome
Timeframe: Week 24, 32, 40 and 48Population: ITT Population
Participants who use concomitant corticosteroid at baseline and entered Maintenance period were included in the analysis.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=7 Participants
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.
|
Placebo
n=4 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=6 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero
Week 24
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero
Week 32
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero
Week 40
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero
Week 48
|
14.3 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 untill Week 48Population: Safety Population
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events
Any TEAEs
|
16 Participants
|
9 Participants
|
13 Participants
|
|
Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events
Any Serious TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events
Any Moderate or Severe TEAE
|
10 Participants
|
6 Participants
|
10 Participants
|
|
Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events
ANY TEAE suspected to be related to study drug
|
6 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 1 untill Week 48Population: Safety Population
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 untill Week 48Population: Safety Population
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 untill Week 48Population: Safety Population
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
n=16 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 till Week 48Population: Safety Population
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=20 Participants
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.
|
Placebo
n=12 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction and Maintenance: Number of Participants With Anti-Drug-Antibody
|
2 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: 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.
Blood samples were collected to assess CC-93538 trough concentrations.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=30 Participants
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.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Induction Phase: CC-93538 Trough Concentration at Week 16
|
179472.2 ng/mL
Geometric Coefficient of Variation 47.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
CC-93538 360 mg QW
n=9 Participants
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.
|
Placebo
n=7 Participants
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Placebo
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
|---|---|---|---|
|
Maintenance Phase: CC-93538 Trough Concentration at Week 48
|
165591.7 ng/mL
Geometric Coefficient of Variation 58.5
|
76433.4 ng/mL
Geometric Coefficient of Variation 64.1
|
—
|
Adverse Events
Induction and Maintenance - CC-93538 360mg QW
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Maintenance - CC-93538 360mg QW/Q2W
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Induction and Maintenance - Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Open-label Long-term Extension Phase - CC-93538 360mg QW
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction and Maintenance - CC-93538 360mg QW
n=20 participants at risk
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.
|
Maintenance - CC-93538 360mg QW/Q2W
n=12 participants at risk
Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.
|
Induction and Maintenance - Placebo
n=16 participants at risk
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Open-label Long-term Extension Phase - CC-93538 360mg QW
n=44 participants at risk
Participants with Eosinophilic Gastroenteritis earlier randomized to Induction and Maintenance phase received 360 mg CC-93538 subcutaneously (SC) once weekly in Open-Label Long-term Extension phase.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
Other adverse events
| Measure |
Induction and Maintenance - CC-93538 360mg QW
n=20 participants at risk
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.
|
Maintenance - CC-93538 360mg QW/Q2W
n=12 participants at risk
Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.
|
Induction and Maintenance - Placebo
n=16 participants at risk
Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.
|
Open-label Long-term Extension Phase - CC-93538 360mg QW
n=44 participants at risk
Participants with Eosinophilic Gastroenteritis earlier randomized to Induction and Maintenance phase received 360 mg CC-93538 subcutaneously (SC) once weekly in Open-Label Long-term Extension phase.
|
|---|---|---|---|---|
|
Infections and infestations
Herpes simplex
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Eye disorders
Cataract
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
4.5%
2/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Eye disorders
Dry eye
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Eye disorders
Iritis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
2/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Haematochezia
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
16.7%
2/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
4.5%
2/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
General disorders
Fatigue
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
General disorders
Injection site reaction
|
25.0%
5/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
16.7%
2/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
11.4%
5/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
General disorders
Malaise
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
4.5%
2/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
25.0%
4/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.8%
3/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Immune system disorders
Anaphylactic reaction
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Immune system disorders
Food allergy
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
12.5%
2/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
4.5%
2/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
COVID-19
|
10.0%
2/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
33.3%
4/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
18.2%
8/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Device related infection
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Hordeolum
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
13.6%
6/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
50.0%
6/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
18.8%
3/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
9.1%
4/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Perineal abscess
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Periodontitis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Pneumonia aspiration
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Pneumonia bacterial
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
4.5%
2/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.8%
3/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
10.0%
2/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Investigations
Eosinophil count increased
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Nervous system disorders
Essential tremor
|
10.0%
2/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.8%
3/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
12.5%
2/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Psychiatric disorders
Anxiety disorder
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
4.5%
2/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic bronchitis
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Respiratory, thoracic and mediastinal disorders
NSAID exacerbated respiratory disease
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
4.5%
2/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
2.3%
1/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
8.3%
1/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.2%
1/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
6.8%
3/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
|
Vascular disorders
Orthostatic hypotension
|
5.0%
1/20 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/12 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/16 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
0.00%
0/44 • All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER