Trial Outcomes & Findings for A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp (NCT NCT03123471)
NCT ID: NCT03123471
Last Updated: 2020-05-13
Results Overview
The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
303 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2020-05-13
Participant Flow
303 participants were randomized to study treatment at 41 sites in the United States and Canada.
Participants were randomly assigned in a 2:1 ratio to receive either apremilast or placebo. Randomization was stratified by baseline Scalp Physician Global Assessment (ScPGA) score (moderate \[3\], severe \[4\]) to ensure balance between treatment arms with respect to baseline severity of scalp psoriasis.
Participant milestones
| Measure |
Placebo/Apremilast
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Placebo-controlled Phase
STARTED
|
102
|
201
|
|
Placebo-controlled Phase
Received at Least 1 Dose of Study Drug
|
102
|
200
|
|
Placebo-controlled Phase
COMPLETED
|
84
|
168
|
|
Placebo-controlled Phase
NOT COMPLETED
|
18
|
33
|
|
Apremilast Extension Phase
STARTED
|
84
|
165
|
|
Apremilast Extension Phase
Received at Least 1 Dose of Study Drug
|
84
|
163
|
|
Apremilast Extension Phase
COMPLETED
|
76
|
140
|
|
Apremilast Extension Phase
NOT COMPLETED
|
8
|
25
|
Reasons for withdrawal
| Measure |
Placebo/Apremilast
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Placebo-controlled Phase
Adverse Event
|
3
|
8
|
|
Placebo-controlled Phase
Lack of Efficacy
|
3
|
4
|
|
Placebo-controlled Phase
Withdrawal by Subject
|
6
|
16
|
|
Placebo-controlled Phase
Non-compliance with Study Drug
|
3
|
0
|
|
Placebo-controlled Phase
Lost to Follow-up
|
1
|
3
|
|
Placebo-controlled Phase
Protocol Deviation
|
2
|
1
|
|
Placebo-controlled Phase
Miscellaneous
|
0
|
1
|
|
Apremilast Extension Phase
Lost to Follow-up
|
2
|
5
|
|
Apremilast Extension Phase
Adverse Event
|
1
|
5
|
|
Apremilast Extension Phase
Lack of Efficacy
|
2
|
8
|
|
Apremilast Extension Phase
Withdrawal by Subject
|
3
|
7
|
Baseline Characteristics
A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Baseline characteristics by cohort
| Measure |
Placebo/Apremilast
n=102 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=201 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.7 Years
STANDARD_DEVIATION 15.15 • n=5 Participants
|
47.0 Years
STANDARD_DEVIATION 15.02 • n=7 Participants
|
46.9 Years
STANDARD_DEVIATION 15.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Duration of Plaque Psoriasis
|
14.75 Years
STANDARD_DEVIATION 11.262 • n=5 Participants
|
15.67 Years
STANDARD_DEVIATION 12.405 • n=7 Participants
|
15.36 Years
STANDARD_DEVIATION 12.022 • n=5 Participants
|
|
Scalp Physician Global Assessment (ScPGA) Score
0 (Clear)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Scalp Physician Global Assessment (ScPGA) Score
1 (Almost Clear)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Scalp Physician Global Assessment (ScPGA) Score
2 (Mild)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Scalp Physician Global Assessment (ScPGA) Score
3 (Moderate)
|
78 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Scalp Physician Global Assessment (ScPGA) Score
4 (Severe)
|
24 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.66 kg/m^2
STANDARD_DEVIATION 7.175 • n=5 Participants
|
30.66 kg/m^2
STANDARD_DEVIATION 7.100 • n=7 Participants
|
31.00 kg/m^2
STANDARD_DEVIATION 7.129 • n=5 Participants
|
|
Whole Body Itch Numeric Rating Scale (NRS)
|
7.2 Units on a Scale
STANDARD_DEVIATION 1.99 • n=5 Participants
|
7.2 Units on a Scale
STANDARD_DEVIATION 2.25 • n=7 Participants
|
7.2 Units on a Scale
STANDARD_DEVIATION 2.16 • n=5 Participants
|
|
Scalp Itch NRS Score
|
6.7 Units on a Scale
STANDARD_DEVIATION 2.41 • n=5 Participants
|
6.6 Units on a Scale
STANDARD_DEVIATION 2.49 • n=7 Participants
|
6.7 Units on a Scale
STANDARD_DEVIATION 2.46 • n=5 Participants
|
|
Dermatological Life Quality Index (DLQI) Score
|
12.6 Units on a Scale
STANDARD_DEVIATION 7.20 • n=5 Participants
|
12.6 Units on a Scale
STANDARD_DEVIATION 7.03 • n=7 Participants
|
12.6 Units on a Scale
STANDARD_DEVIATION 7.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: The intent to treat (ITT) population included participants who were randomized. Missing values were imputed using the multiple imputation (MI) method.
The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.
Outcome measures
| Measure |
Placebo/Apremilast
n=102 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=201 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline
|
13.7 Percentage of Participants
Interval 6.6 to 20.8
|
43.3 Percentage of Participants
Interval 36.2 to 50.5
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Participants in the ITT population who had a baseline Body Itch NRS Score ≥4. Missing values were imputed using the multiple imputation method.
The Whole Body Itch NRS scale is an 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity. NRS response was defined as a ≥ 4-point reduction (improvement) from baseline.
Outcome measures
| Measure |
Placebo/Apremilast
n=94 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=185 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16
|
22.5 Percentage of Participants
Interval 13.7 to 31.3
|
45.5 Percentage of Participants
Interval 38.1 to 52.9
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Includes participants in the ITT population had baseline scalp itch NRS Score ≥ 4. Missing values were imputed using the multiple imputation method.
The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.
Outcome measures
| Measure |
Placebo/Apremilast
n=90 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=175 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16
|
21.1 Percentage of Participants
Interval 11.8 to 30.3
|
47.1 Percentage of Participants
Interval 39.5 to 54.7
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 6, 8 and 12Population: Participants in the ITT population with a baseline whole body itch NRS Score ≥ 4. Missing values were imputed using the multiple imputation method.
The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.
Outcome measures
| Measure |
Placebo/Apremilast
n=94 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=185 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
Week 2
|
3.5 Percentage of Participants
Interval -0.4 to 7.4
|
20.5 Percentage of Participants
Interval 14.6 to 26.4
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
Week 4
|
10.1 Percentage of Participants
Interval 3.9 to 16.3
|
32.3 Percentage of Participants
Interval 25.4 to 39.1
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
Week 8
|
19.7 Percentage of Participants
Interval 11.4 to 27.9
|
39.8 Percentage of Participants
Interval 32.6 to 47.1
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
Week 12
|
26.3 Percentage of Participants
Interval 17.0 to 35.7
|
47.0 Percentage of Participants
Interval 39.6 to 54.3
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 8 and 12Population: The intent to treat population included participants who were randomized; analysis includes participants with a baseline scalp itch NRS Score ≥4. Missing values were imputed using the multiple imputation method.
The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.
Outcome measures
| Measure |
Placebo/Apremilast
n=90 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=175 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
Week 2
|
11.5 Percentage of Participants
Interval 4.8 to 18.2
|
26.1 Percentage of Participants
Interval 19.5 to 32.7
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
Week 4
|
16.5 Percentage of Participants
Interval 8.7 to 24.4
|
37.8 Percentage of Participants
Interval 30.5 to 45.0
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
Week 8
|
23.7 Percentage of Participants
Interval 14.6 to 32.9
|
45.6 Percentage of Participants
Interval 38.1 to 53.2
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
Week 12
|
19.6 Percentage of Participants
Interval 10.6 to 28.5
|
46.5 Percentage of Participants
Interval 38.9 to 54.1
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: The intent to treat population included participants who were randomized. Missing values were imputed using the multiple imputation method.
DLQI is questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, and has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Outcome measures
| Measure |
Placebo/Apremilast
n=102 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=201 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16
|
-3.8 Units on a Scale
Standard Error 0.56
|
-6.7 Units on a Scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.Population: Safety population includes participants who received at least 1 dose of study drug.
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
Outcome measures
| Measure |
Placebo/Apremilast
n=200 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=102 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any TEAE
|
135 Participants
|
52 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any Drug-related TEAE
|
99 Participants
|
22 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any Severe TEAE
|
5 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any Serious TEAE
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any TEAE Leading to Drug Interruption
|
9 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Any TEAE Leading to Drug Withdrawal
|
11 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectivelyPopulation: Safety population includes participants who received at least 1 dose of study drug. Participants who entered into the apremilast extension phase and were treated.
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
Outcome measures
| Measure |
Placebo/Apremilast
n=84 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=163 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Any TEAE
|
35 Participants
|
66 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Any Drug-related TEAE
|
17 Participants
|
17 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Any Severe TEAE
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Any Serious TEAE
|
1 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Any TEAE Leading to Drug Interruption
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Any TEAE Leading to Drug Withdrawal
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 to 32;Population: The apremilast participants as treated population, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.
The apremilast-exposure period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
Outcome measures
| Measure |
Placebo/Apremilast
n=84 Participants
Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
|
Apremilast
n=200 Participants
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Any TEAE
|
35 Participants
|
144 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Any Drug-related TEAE
|
17 Participants
|
103 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Any Severe TEAE
|
2 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Any Serious TEAE
|
1 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Any Serious TEAE Drug Related TEAE
|
0 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Any TEAE Leading to Drug Interruption
|
2 Participants
|
13 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Any TEAE Leading to Drug Withdrawal
|
1 Participants
|
15 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Deaths
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo (Weeks 0-16)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Apremilast 30 mg (Weeks 0-16)
Serious events: 2 serious events
Other events: 95 other events
Deaths: 0 deaths
Placebo/Apremilast (APR Extension Phase Weeks 16-32)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Apremilast /Apremilast (APR Exposure Period, Weeks 0-32)
Serious events: 6 serious events
Other events: 101 other events
Deaths: 0 deaths
Apremilast Total (APR Exposure Period, Weeks 0-32)
Serious events: 7 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Weeks 0-16)
n=102 participants at risk
Participants received identically matching placebo capsules twice daily during the 16-week placebo-controlled phase.
|
Apremilast 30 mg (Weeks 0-16)
n=200 participants at risk
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase.
|
Placebo/Apremilast (APR Extension Phase Weeks 16-32)
n=84 participants at risk
Participants initially randomized to placebo capsules BID during the placebo controlled phase were switched to apremilast 30 mg capsules BID at week 16 and continued apremilast up to Week 32.
|
Apremilast /Apremilast (APR Exposure Period, Weeks 0-32)
n=200 participants at risk
Participants received apremilast 30 mg capsules BID during the placebo-controlled phase and continued to receive apremilast 30 mg BID capsules from weeks 16 to week 32.
|
Apremilast Total (APR Exposure Period, Weeks 0-32)
n=284 participants at risk
Participants who started apremilast 30 mg BID at any time during the study (Week 0 for participants originally randomized to apremilast or at week 16 for participants originally randomized to placebo.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.98%
1/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
1.2%
1/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.00%
0/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.50%
1/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
0.35%
1/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
Other adverse events
| Measure |
Placebo (Weeks 0-16)
n=102 participants at risk
Participants received identically matching placebo capsules twice daily during the 16-week placebo-controlled phase.
|
Apremilast 30 mg (Weeks 0-16)
n=200 participants at risk
Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase.
|
Placebo/Apremilast (APR Extension Phase Weeks 16-32)
n=84 participants at risk
Participants initially randomized to placebo capsules BID during the placebo controlled phase were switched to apremilast 30 mg capsules BID at week 16 and continued apremilast up to Week 32.
|
Apremilast /Apremilast (APR Exposure Period, Weeks 0-32)
n=200 participants at risk
Participants received apremilast 30 mg capsules BID during the placebo-controlled phase and continued to receive apremilast 30 mg BID capsules from weeks 16 to week 32.
|
Apremilast Total (APR Exposure Period, Weeks 0-32)
n=284 participants at risk
Participants who started apremilast 30 mg BID at any time during the study (Week 0 for participants originally randomized to apremilast or at week 16 for participants originally randomized to placebo.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
11/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
30.5%
61/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
16.7%
14/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
31.0%
62/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
26.8%
76/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
6/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
21.5%
43/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
9.5%
8/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
23.5%
47/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
19.4%
55/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
5.5%
11/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
2.4%
2/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
6.5%
13/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
5.3%
15/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
General disorders
Fatigue
|
3.9%
4/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
4.5%
9/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
2.4%
2/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
6.0%
12/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
4.9%
14/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Infections and infestations
Influenza
|
2.0%
2/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
4.0%
8/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
2.4%
2/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
5.0%
10/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
4.2%
12/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
|
Nervous system disorders
Headache
|
4.9%
5/102 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
12.0%
24/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
3.6%
3/84 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
12.5%
25/200 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
9.9%
28/284 • From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;
AEs are reported for the Apremilast Exposure Period from Week 0 to Week 32; the mean treatment duration to apremilast was 23.2 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is \> 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
- Publication restrictions are in place
Restriction type: OTHER