Trial Outcomes & Findings for Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis (NCT NCT02087943)
NCT ID: NCT02087943
Last Updated: 2020-05-07
Results Overview
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
191 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2020-05-07
Participant Flow
Treatment assignment was stratified by geographic region and within each region, by the Eczema Area and Severity Index (EASI) score (≤ 20 or \> 20). Six participants were excluded from analysis due to unsigned case books; a total of 185 participants were included in the final analyses.
Participant milestones
| Measure |
Placebo
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase
|
Apremilast 40 mg
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase.
|
Placebo/Apremilast 30 mg
Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24.
|
Placebo/Apremilast 40 mg
Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24.
|
|---|---|---|---|---|---|
|
Placebo-Controlled Phase Week 0-12
STARTED
|
64
|
58
|
63
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-12
Safety Population
|
64
|
58
|
63
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-12
COMPLETED
|
50
|
46
|
50
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-12
NOT COMPLETED
|
14
|
12
|
13
|
0
|
0
|
|
Active Treatment Phase Week 12-24
STARTED
|
0
|
46
|
49
|
24
|
23
|
|
Active Treatment Phase Week 12-24
COMPLETED
|
0
|
42
|
44
|
22
|
21
|
|
Active Treatment Phase Week 12-24
NOT COMPLETED
|
0
|
4
|
5
|
2
|
2
|
|
Observational Follow-up Phase Week 24-30
STARTED
|
0
|
46
|
48
|
24
|
23
|
|
Observational Follow-up Phase Week 24-30
COMPLETED
|
0
|
46
|
45
|
23
|
22
|
|
Observational Follow-up Phase Week 24-30
NOT COMPLETED
|
0
|
0
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase
|
Apremilast 40 mg
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase.
|
Placebo/Apremilast 30 mg
Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24.
|
Placebo/Apremilast 40 mg
Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24.
|
|---|---|---|---|---|---|
|
Placebo-Controlled Phase Week 0-12
Adverse Event
|
1
|
2
|
6
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-12
Lack of Efficacy
|
8
|
7
|
4
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-12
Withdrawal by Subject
|
4
|
2
|
2
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-12
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-12
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Active Treatment Phase Week 12-24
Adverse Event
|
0
|
1
|
2
|
0
|
1
|
|
Active Treatment Phase Week 12-24
Lack of Efficacy
|
0
|
3
|
1
|
1
|
0
|
|
Active Treatment Phase Week 12-24
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Active Treatment Phase Week 12-24
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Active Treatment Phase Week 12-24
Other-Unspecified
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=64 Participants
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
|
Apremilast 30 mg
n=58 Participants
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg
n=63 Participants
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 14.71 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 15.80 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 14.74 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 15.00 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: All participants who were randomized as specified per protocol and who received at least one dose of IP with a baseline and at least 1 post baseline value at or before week 12; A missing value at Week 12 was imputed by last observation carried forward (LOCF), including the value obtained at the Early Termination Visit prior to Week 12.
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg
n=58 Participants
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg
n=63 Participants
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
|---|---|---|---|
|
Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.
|
-10.98 percent change
Standard Error 6.873
|
-25.99 percent change
Standard Error 7.106
|
-31.57 percent change
Standard Error 6.820
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT includes all participants who were randomized as specified per protocol and received at least one dose of IP. LOCF for missing data handling.
The sPGA-A is intended to assess the global severities (ie, a "visual average" integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4).
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg
n=58 Participants
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg
n=63 Participants
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician's Global Assessment of Acute Signs (sPGA-A) at Week 12.
|
6.3 percentage of participants
|
3.4 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT includes all participants who were randomized as specified in the protocol and received at least one dose of IP. LOCF.
The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg
n=58 Participants
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg
n=63 Participants
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12
|
32.8 percentage of participants
|
31.0 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: All participants who were randomized as specified in the protocol and who received at least one dose of IP with a baseline and at least 1 postbaseline value at or before Week 4 were included. LOCF.
The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg
n=58 Participants
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg
n=59 Participants
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
|---|---|---|---|
|
The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4
|
-4.83 percent change
Standard Error 5.657
|
-10.00 percent change
Standard Error 5.911
|
-9.00 percent change
Standard Error 5.850
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Safety population includes all participants who received at least one dose of IP.
A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg
n=58 Participants
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg
n=63 Participants
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
TEAE
|
30 participants
|
36 participants
|
44 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
Drug-related TEAE
|
8 participants
|
26 participants
|
27 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
Severe TEAE
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
Serious TEAE (SAE)
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
Drug-related SAE
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
TEAE Leading to Drug Interruption
|
3 participants
|
0 participants
|
4 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
TEAE Leading to Drug Withdrawal
|
1 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
Death
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mgPopulation: Safety population includes all participants who received at least one dose of IP. These were Apremilast participants as treated.
A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg
n=86 Participants
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
|---|---|---|---|
|
Number of Participants With TEAEs During the Apremilast Exposure Period
TEAE
|
49 participants
|
61 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast Exposure Period
Drug-related TEAE
|
29 participants
|
38 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast Exposure Period
Severe TEAE
|
1 participants
|
1 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast Exposure Period
Serious TEAE (SAE)
|
2 participants
|
3 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast Exposure Period
Drug-related SAE
|
0 participants
|
2 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast Exposure Period
TEAE Leading to Drug Interruption
|
0 participants
|
8 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast Exposure Period
TEAE Leading to Drug Withdrawal
|
3 participants
|
9 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast Exposure Period
Death
|
0 participants
|
0 participants
|
—
|
Adverse Events
Placebo (Weeks 0-12)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Apremilast 30 mg (Weeks 0-12)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Apremilast 40 mg (Weeks 0-12)
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Apremilast 30 mg (Apremilast Exposure Period) 0-24
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Apremilast 40 mg (Apremilast Exposure Period) 0-24
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Weeks 0-12)
n=64 participants at risk
Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg (Weeks 0-12)
n=58 participants at risk
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg (Weeks 0-12)
n=63 participants at risk
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 30 mg (Apremilast Exposure Period) 0-24
n=82 participants at risk
Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
|
Apremilast 40 mg (Apremilast Exposure Period) 0-24
n=86 participants at risk
Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.6%
1/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
2.3%
2/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.7%
1/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.2%
1/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.6%
1/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.2%
1/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.6%
1/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.2%
1/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.2%
1/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
Other adverse events
| Measure |
Placebo (Weeks 0-12)
n=64 participants at risk
Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
|
Apremilast 30 mg (Weeks 0-12)
n=58 participants at risk
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 40 mg (Weeks 0-12)
n=63 participants at risk
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
|
Apremilast 30 mg (Apremilast Exposure Period) 0-24
n=82 participants at risk
Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
|
Apremilast 40 mg (Apremilast Exposure Period) 0-24
n=86 participants at risk
Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
10.3%
6/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
9.5%
6/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
9.8%
8/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
16.3%
14/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
8/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
3.4%
2/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
4.8%
3/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
9.8%
8/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
7.0%
6/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
4.8%
3/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
5.8%
5/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
7.8%
5/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
6.9%
4/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
12.7%
8/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
8.5%
7/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
9.3%
8/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
17.2%
10/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
23.8%
15/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
13.4%
11/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
24.4%
21/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
15.5%
9/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
11.1%
7/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
12.2%
10/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
16.3%
14/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
5.2%
3/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
3.2%
2/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
3.7%
3/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
2.3%
2/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
4.8%
3/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.2%
1/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
5.8%
5/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/64 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
5.2%
3/58 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
0.00%
0/63 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
3.7%
3/82 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
1.2%
1/86 • Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
|
Additional Information
Anne McClain, Senior Manager, Clinical Trial Disclosure
CelgeneCorp
Phone: 1-888-260-1599
Email: [email protected]
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 \> 12 months 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 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
- Publication restrictions are in place
Restriction type: OTHER