Trial Outcomes & Findings for Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP) (NCT NCT05174065)
NCT ID: NCT05174065
Last Updated: 2025-04-09
Results Overview
A PPPASI 50 response is defined as a ≥ 50% reduction in PPPASI total score from baseline. The PPPASI is a system used for assessing and grading the severity (in terms of erythema, pustules/vesicle and desquamation/scale) and area of PPP lesions and their response to therapy. The PPPASI produces a numeric score that can range from 0 to 72, with a higher score indicating more severe disease. Participants who discontinued investigational product before week 16 due to lack of efficacy, adverse event, or use of protocol-prohibited medication (intercurrent events) were to be considered as treatment failures as the result of the intercurrent event and the PPPASI-50 values for visits on and after the intercurrent event were imputed as non-responders. The missing PPPASI-50 values due to the other reasons were imputed using the multiple imputation method.
COMPLETED
PHASE3
176 participants
Baseline and Week 16
2025-04-09
Participant Flow
Participants with palmoplantar pustulosis (PPP) took part in the study at 40 centers in Japan between 08 March 2022 and 01 June 2024.
A total of 176 participants were enrolled in the placebo-controlled period. Of these, 172 participants were enrolled in the active treatment period.
Participant milestones
| Measure |
Placebo-controlled Period: Placebo
Participants took oral placebo matching apremilast tablets twice daily (BID) from Week 0 to Week 16 during the placebo-controlled period.
|
Placebo-controlled Period: Apremilast
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16 during the placebo-controlled period.
|
Active Treatment Period: Apremilast
Participants who were randomized to placebo during the placebo-controlled period took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 16 to Week 52. Participants who were randomized to apremilast during the placebo-controlled period took oral 30 mg apremilast tablets BID from Week 16 to Week 52.
|
|---|---|---|---|
|
Placebo-controlled Period
STARTED
|
88
|
88
|
0
|
|
Placebo-controlled Period
Received Apremilast or Placebo During Placebo-controlled Period
|
88
|
88
|
0
|
|
Placebo-controlled Period
COMPLETED
|
86
|
86
|
0
|
|
Placebo-controlled Period
NOT COMPLETED
|
2
|
2
|
0
|
|
Apremilast Active Treatment Period
STARTED
|
0
|
0
|
172
|
|
Apremilast Active Treatment Period
Received Apremilast During the Active Treatment Period
|
0
|
0
|
172
|
|
Apremilast Active Treatment Period
COMPLETED
|
0
|
0
|
164
|
|
Apremilast Active Treatment Period
NOT COMPLETED
|
0
|
0
|
8
|
Reasons for withdrawal
| Measure |
Placebo-controlled Period: Placebo
Participants took oral placebo matching apremilast tablets twice daily (BID) from Week 0 to Week 16 during the placebo-controlled period.
|
Placebo-controlled Period: Apremilast
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16 during the placebo-controlled period.
|
Active Treatment Period: Apremilast
Participants who were randomized to placebo during the placebo-controlled period took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 16 to Week 52. Participants who were randomized to apremilast during the placebo-controlled period took oral 30 mg apremilast tablets BID from Week 16 to Week 52.
|
|---|---|---|---|
|
Placebo-controlled Period
Withdrawal by Subject
|
1
|
0
|
0
|
|
Placebo-controlled Period
Other
|
0
|
1
|
0
|
|
Placebo-controlled Period
Adverse Event
|
1
|
1
|
0
|
|
Apremilast Active Treatment Period
Withdrawal by Subject
|
0
|
0
|
3
|
|
Apremilast Active Treatment Period
Protocol Violation
|
0
|
0
|
1
|
|
Apremilast Active Treatment Period
Adverse Event
|
0
|
0
|
4
|
Baseline Characteristics
Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
Baseline characteristics by cohort
| Measure |
Placebo-controlled Period: Placebo
n=88 Participants
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=88 Participants
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 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
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
176 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/Ethnicity, Customized
Asian
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: ITT Population: Included all randomized participants.
A PPPASI 50 response is defined as a ≥ 50% reduction in PPPASI total score from baseline. The PPPASI is a system used for assessing and grading the severity (in terms of erythema, pustules/vesicle and desquamation/scale) and area of PPP lesions and their response to therapy. The PPPASI produces a numeric score that can range from 0 to 72, with a higher score indicating more severe disease. Participants who discontinued investigational product before week 16 due to lack of efficacy, adverse event, or use of protocol-prohibited medication (intercurrent events) were to be considered as treatment failures as the result of the intercurrent event and the PPPASI-50 values for visits on and after the intercurrent event were imputed as non-responders. The missing PPPASI-50 values due to the other reasons were imputed using the multiple imputation method.
Outcome measures
| Measure |
Placebo-controlled Period: Placebo
n=88 Participants
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=88 Participants
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score (PPPASI-50) at Week 16
|
35.3 percentage of participants
Interval 25.3 to 45.4
|
67.8 percentage of participants
Interval 57.9 to 77.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included.
The PPPASI is a system used for assessing and grading the severity (in terms of erythema, pustules/vesicle and desquamation/scale) and area of PPP lesions and their response to therapy. The PPPASI produces a numeric score that can range from 0 to 72, with a higher score indicating more severe disease. A negative change from baseline indicates a reduction in disease severity. The continuous endpoints collected on and after the participant experienced treatment failure as the result of intercurrent event (IE) (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the mixed-effects model for repeated measures (MMRM) application.
Outcome measures
| Measure |
Placebo-controlled Period: Placebo
n=86 Participants
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=87 Participants
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Change From Baseline in PPPASI Total Score at Week 16
|
-5.98 score on a scale
Standard Error 0.999
|
-12.12 score on a scale
Standard Error 1.002
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included.
The PPSI is a system used for assessing and grading the severity of PPP lesions and their response to therapy. Evaluation of skin lesion site are assessed separately for erythema, pustules/vesicle and desquamation/scale, where each are rated on a scale of 0 to 4 and summed to produce a numeric total score than can range from 0 to 12, with a higher score indicating more severe disease. A negative change from baseline indicates a reduction in disease severity. The continuous endpoints collected on and after the participant experienced treatment failure as the result of IE (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the MMRM application.
Outcome measures
| Measure |
Placebo-controlled Period: Placebo
n=86 Participants
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=87 Participants
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16
|
-1.9 score on a scale
Standard Error 0.24
|
-3.4 score on a scale
Standard Error 0.24
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included.
Participants assessed the degree of pruritus itching symptoms on palms and soles caused by PPP on a VAS. The VAS score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no itch and the right-hand boundary (100) represents itch as severe as can be imagined by the participant. A negative change from baseline indicates a reduction in disease severity. The continuous endpoints collected on and after the participant experienced treatment failure as the result of IE (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the MMRM application.
Outcome measures
| Measure |
Placebo-controlled Period: Placebo
n=86 Participants
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=87 Participants
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16
|
-9.9 score on a scale
Standard Error 2.68
|
-17.6 score on a scale
Standard Error 2.67
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included.
Participants assessed the degree of pain/discomfort symptoms on palms and soles caused by PPP on a VAS. The VAS score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no pain/discomfort and the right-hand boundary (100) represents pain/discomfort as severe as can be imagined by the participant. A negative change from baseline indicates a reduction in disease severity. The continuous endpoints collected on and after the participant experienced treatment failure as the result of IE (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the MMRM application.
Outcome measures
| Measure |
Placebo-controlled Period: Placebo
n=86 Participants
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=87 Participants
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16
|
-7.5 score on a scale
Standard Error 2.97
|
-18.3 score on a scale
Standard Error 2.96
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included.
The DLQI is a skin disease-specific Quality of Life (QoL) questionnaire comprised of 10 items assessing the participant's status over the previous week. The DLQI was used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score ranging from 0 to 30, with a higher score indicating more severe disease. A negative change from baseline indicates a reduction in disease severity. The continuous endpoints collected on and after the participant experienced treatment failure as the result of IE (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the MMRM application.
Outcome measures
| Measure |
Placebo-controlled Period: Placebo
n=87 Participants
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=87 Participants
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
|
-0.8 score on a scale
Standard Error 0.37
|
-2.3 score on a scale
Standard Error 0.37
|
—
|
SECONDARY outcome
Timeframe: Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)Population: Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
TEAEs were defined as any untoward medical occurrence in a participant irrespective of a causal relationship with the study treatment that began or worsened on or after the first dose of study treatment. A serious TEAE met at least 1 of the following criteria: * Resulted in death. * Was immediately life-threatening. * Required in-patient hospitalization or prolongation of existing hospitalization. * Resulted in persistent or significant disability/incapacity. * Was a congenital anomaly/birth defect. * Was any other medically important serious event. TEAEs of interest were defined as any of the following: * Depression. * Serious infection. * Risk of triggering suicide. * Serious diarrhea, nausea and vomiting. * Malignancies. * Vasculitis and Vasculopathy. * Serious Hypersensitivity. * Weight change (weight decrease). Clinically significant changes in body weight, vital signs and laboratory abnormalities were also recorded as TEAEs.
Outcome measures
| Measure |
Placebo-controlled Period: Placebo
n=88 Participants
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=88 Participants
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
n=174 Participants
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Any TEAEs
|
43 Participants
|
63 Participants
|
148 Participants
|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Serious TEAEs
|
1 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs of Interest
|
3 Participants
|
1 Participants
|
8 Participants
|
Adverse Events
Placebo-controlled Period: Placebo
Placebo-controlled Period: Apremilast
Apremilast Exposure Period: Apremilast
Serious adverse events
| Measure |
Placebo-controlled Period: Placebo
n=88 participants at risk
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=88 participants at risk
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
n=174 participants at risk
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
1/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Cataract
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
1.1%
2/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.57%
1/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.57%
1/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pseudoaneurysm infection
|
1.1%
1/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.57%
1/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.57%
1/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Viral infection
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.57%
1/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.57%
1/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
1.1%
1/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.57%
1/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.57%
1/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
Other adverse events
| Measure |
Placebo-controlled Period: Placebo
n=88 participants at risk
Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16.
|
Placebo-controlled Period: Apremilast
n=88 participants at risk
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
Apremilast Exposure Period: Apremilast
n=174 participants at risk
Participants who received any apremilast during the placebo-controlled or active treatment periods.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
19.3%
17/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
17.8%
31/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Faeces soft
|
1.1%
1/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
17.0%
15/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
12.6%
22/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
11.4%
10/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
13.2%
23/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
COVID-19
|
4.5%
4/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
4.5%
4/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
10.3%
18/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
8/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
4.5%
4/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
16.1%
28/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
5/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
2.9%
5/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Headache
|
2.3%
2/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
11.4%
10/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
10.9%
19/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.4%
3/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
5.7%
5/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
6.3%
11/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
5.7%
5/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
4.5%
4/88 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
6.9%
12/174 • Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Safety Population: Included all randomized participants who received at least 1 dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER