Trial Outcomes & Findings for Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis (NCT NCT01988103)
NCT ID: NCT01988103
Last Updated: 2020-05-07
Results Overview
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.
COMPLETED
PHASE2
254 participants
Baseline to Week 16
2020-05-07
Participant Flow
Participants must have had a diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening and which was considered inappropriate for topical therapy (e.g, based on the severity of the disease and extent of affected area) or could not be adequately controlled/treated with topical therapy to qualify for the study.
Treatment assignments were stratified according to whether the participants had a psoriatic arthritis (PsA) diagnosis by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (yes/no) at screening, whether they participated in the sparse pharmacokinetic (PK) sampling, and whether they had participated in the intensive PK sampling.
Participant milestones
| Measure |
Placebo
Participants who were initially randomized to identically matching placebo (PBO) by mouth (PO) twice a day (BID) during the Placebo-controlled Phase (Weeks 0-16).
|
Apremilast 20 mg
Participants were randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) and remained on apremilast 20 mg PO BID dosing during the active treatment phase (weeks 16-68).
|
Apremilast 30 mg
Participants were randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) and remained on apremilast 30 mg PO BID dosing during the active treatment phase (weeks 16-68).
|
Placebo-Apremilast 20 mg
Participants who were initially randomized to identically matching PBO PO BID during the Placebo-controlled Phase (weeks 0-16) were re-randomized to apremilast 20 mg PO BID and remained on apremilast 20 mg PO BID dosing during the active treatment phase (weeks 16-68).
|
Placebo-Apremilast 30 mg
Participants who were initially randomized to identically matching PBO PO BID during the Placebo-controlled Phase (weeks 0-16) were re-randomized to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (weeks 16-68).
|
|---|---|---|---|---|---|
|
Placebo-Controlled Phase Week 0-16
STARTED
|
84
|
85
|
85
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-16
COMPLETED
|
72
|
69
|
76
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-16
NOT COMPLETED
|
12
|
16
|
9
|
0
|
0
|
|
Active Treatment Phase (Weeks 16-68)
STARTED
|
0
|
69
|
76
|
36
|
35
|
|
Active Treatment Phase (Weeks 16-68)
COMPLETED
|
0
|
56
|
65
|
33
|
30
|
|
Active Treatment Phase (Weeks 16-68)
NOT COMPLETED
|
0
|
13
|
11
|
3
|
5
|
|
Observational Follow-up Phase
STARTED
|
12
|
82
|
83
|
36
|
33
|
|
Observational Follow-up Phase
COMPLETED
|
12
|
79
|
82
|
36
|
33
|
|
Observational Follow-up Phase
NOT COMPLETED
|
0
|
3
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants who were initially randomized to identically matching placebo (PBO) by mouth (PO) twice a day (BID) during the Placebo-controlled Phase (Weeks 0-16).
|
Apremilast 20 mg
Participants were randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) and remained on apremilast 20 mg PO BID dosing during the active treatment phase (weeks 16-68).
|
Apremilast 30 mg
Participants were randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) and remained on apremilast 30 mg PO BID dosing during the active treatment phase (weeks 16-68).
|
Placebo-Apremilast 20 mg
Participants who were initially randomized to identically matching PBO PO BID during the Placebo-controlled Phase (weeks 0-16) were re-randomized to apremilast 20 mg PO BID and remained on apremilast 20 mg PO BID dosing during the active treatment phase (weeks 16-68).
|
Placebo-Apremilast 30 mg
Participants who were initially randomized to identically matching PBO PO BID during the Placebo-controlled Phase (weeks 0-16) were re-randomized to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (weeks 16-68).
|
|---|---|---|---|---|---|
|
Placebo-Controlled Phase Week 0-16
Adverse Event
|
3
|
10
|
6
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-16
Lack of Efficacy
|
1
|
2
|
2
|
0
|
0
|
|
Placebo-Controlled Phase Week 0-16
Withdrawal by Subject
|
8
|
4
|
1
|
0
|
0
|
|
Active Treatment Phase (Weeks 16-68)
Adverse Event
|
0
|
6
|
3
|
3
|
2
|
|
Active Treatment Phase (Weeks 16-68)
Lack of Efficacy
|
0
|
1
|
2
|
0
|
0
|
|
Active Treatment Phase (Weeks 16-68)
Withdrawal by Subject
|
0
|
5
|
4
|
0
|
1
|
|
Active Treatment Phase (Weeks 16-68)
Principal Investigator Signature Missing
|
0
|
1
|
2
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20 mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
Apremilast 30 mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 12.54 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 12.73 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 12.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
84 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: mITT consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the Last observation carried forward (LOCF) method.
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.
Outcome measures
| Measure |
Apremilast 30mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16
|
28.2 percentage of participants
|
7.1 percentage of participants
|
23.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population with a sPGA greater than 2 at baseline. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.
The sPGA is a measure of psoriasis disease severity at the time of evaluation by the Investigator. It does not compare assessments across visits or rely on investigator recall or prior disease. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equals the overall sPGA score.
Outcome measures
| Measure |
Apremilast 30mg
n=71 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=68 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=71 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Point Reduction From Baseline to Week 16
|
29.6 percentage of participants
|
8.8 percentage of participants
|
23.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.
BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area.
Outcome measures
| Measure |
Apremilast 30mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) at Week 16
|
-30.5 percent change
Standard Error 5.51
|
7.5 percent change
Standard Error 5.56
|
-21.6 percent change
Standard Error 5.52
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI is a validated instrument that has become standard in clinical trials for psoriasis. The PASI scores range from 0 to 72, with higher scores reflecting a greater disease severity.
Outcome measures
| Measure |
Apremilast 30mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Percent Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
|
-43.1 percent change
Standard Error 5.50
|
-3.7 percent change
Standard Error 5.55
|
-33.1 percent change
Standard Error 5.51
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.
PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.
Outcome measures
| Measure |
Apremilast 30mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a 50% Improvement From Baseline (Response) Reduction in the PASI-50 at Week 16
|
50.6 percentage of participants
|
21.4 percentage of participants
|
41.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.
The pruritus visual analog scale (VAS) was used to measure the amount of itching and discomfort a participant experiences. Participant's assessment of pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? Higher scores correspond to more severe symptom or disease. The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no itch at all and the right-hand boundary represents the worst itch imaginable. The distance from the vertical line to the left-hand boundary is recorded. VAS scores range from 0 to 100 mm, where higher scores correspond to worse pruritis (itch).
Outcome measures
| Measure |
Apremilast 30mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Change From Baseline in Pruritus Visual Analogue Scale 100-mm (VAS) at Week 16
|
-17.7 units on a scale
Standard Error 2.83
|
7.1 units on a scale
Standard Error 2.86
|
-7.5 units on a scale
Standard Error 2.84
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.
Dermatology Life Quality Index (DLQI) was developed as a practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains 10 items dealing with the participants 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 participant 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 has a possible range from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Outcome measures
| Measure |
Apremilast 30mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
|
-2.2 units on a scale
Standard Error 0.52
|
1.3 units on a scale
Standard Error 0.53
|
-0.5 units on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized.
SF-36 is a 36-item general health status instrument often used in clinical trials and health services research. It consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better quality of life (better functioning)
Outcome measures
| Measure |
Apremilast 30mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Change From Baseline in Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16
|
0.27 units on a scale
Standard Error 0.948
|
-1.59 units on a scale
Standard Error 0.953
|
-0.71 units on a scale
Standard Error 0.953
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Due to the small sample size in the study for the ACR 20 % improvement, the analysis was not conducted. The decision not to perform the analysis was authorized by the lead therapeutic executive and there is no data available to analyze. No resources are available to conduct the ACR 20% improvement endpoint for this population.
The ACR 20 is defined as a 20% improvement in joint tenderness (78 joint count) and joint swelling scores (76 joint count) compared to baseline plus 20% improvements in 3 of the following 5 assessments (compared to baseline): subject global assessment of disease activity (measured on a 100-mm visual analog scale \[VAS\]); physician global assessment of disease activity (measured on a 100-mm VAS); subject self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\] score); subject assessment of pain (measured on a 100-mm VAS); and CRP level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Due to the small sample size in the study for change from baseline in psoriatic arthritis pain VAS, the analysis was not conducted. The decision not to perform the analysis was authorized by the lead therapeutic executive and there is no data to analyze. No resources are available to conduct the analysis for the end point.
Change from baseline in psoriatic arthritis pain 100-mm VAS; The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no pain at all and the right-hand boundary represents the worst possible pain. The distance from the vertical line to the left-hand boundary is recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Due to the small sample size for the change from baseline in physical function assessment using the HAQ-DI, the analysis was not conducted. The decision not to perform the analysis was authorized by the lead therapeutic executive and there is no data available to analyze. No resources are available to conduct the analysis for the end point.
Change from baseline in physical function assessment using HAQ-DI; The HAQ-DI is a 20-question, self-administered instrument that measures the subject's functional ability on a 4-level difficulty scale (0-3, with 0 representing normal or no difficulty; and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Safety population consisted of all participants who were randomized and received at least one dose of IP
An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of 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 preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.
Outcome measures
| Measure |
Apremilast 30mg
n=85 Participants
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=84 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=85 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
≥ At least 1 TEAE
|
44 participants
|
35 participants
|
49 participants
|
|
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
≥ 1 Drug-related TEAE
|
25 participants
|
8 participants
|
18 participants
|
|
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
≥ At least 1 Severe TEAE
|
0 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
≥ 1 Serious TEAE
|
0 participants
|
0 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
Any Serious Drug-related TEAE
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
≥ 1 TEAE leading to Drug Interruption
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
≥ 1 TEAE Leading to Drug Withdrawal
|
6 participants
|
4 participants
|
10 participants
|
|
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
≥ 1 TEAE Leading to Death
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo who were re-randomized at Week 16) until 28 days after the last dose of apremilast.Population: All participants who received apremilast at any time during the trial.
An AE was any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of 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 preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.
Outcome measures
| Measure |
Apremilast 30mg
Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
|
Placebo
n=121 Participants
Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
|
Apremilast 20mg
n=120 Participants
Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
≥ At Least 1 TEAE
|
—
|
94 participants
|
89 participants
|
|
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
≥ 1 Drug-related TEAR
|
—
|
34 participants
|
37 participants
|
|
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
≥ At Least 1 Severe TEAE
|
—
|
12 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
≥ 1 Serious TEAE
|
—
|
11 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
Any Serious Drug-related TEAE
|
—
|
5 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
≥ 1 TEAE leading to Drug Interruption
|
—
|
6 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
≥ 1 TEAE Leading to Drug Withdrawal
|
—
|
19 participants
|
10 participants
|
|
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
≥ 1 TEAE Leading to Death
|
—
|
1 participants
|
0 participants
|
Adverse Events
Placebo (Weeks 0-16)
Apremilast 20mg BID (Weeks 0-16)
Apremilast 30mg BID (Weeks 0-16)
Apremilast 20mg BID (Weeks 0-68)
Apremilast 30mg BID (Weeks 0-68)
Serious adverse events
| Measure |
Placebo (Weeks 0-16)
n=84 participants at risk
Participants initially randomized to identically matching placebo (PBO) by mouth (PO) twice a day (BID) during the Placebo-controlled Phase (Weeks 0-16).
|
Apremilast 20mg BID (Weeks 0-16)
n=85 participants at risk
Participants initially randomized to receive apremilast 20 mg BID PO during the Placebo-controlled Phase (Weeks 0-16).
|
Apremilast 30mg BID (Weeks 0-16)
n=85 participants at risk
Participants initially randomized to apremilast 30 mg BID PO during the Placebo-controlled Phase (Weeks 0-16).
|
Apremilast 20mg BID (Weeks 0-68)
n=121 participants at risk
Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 up until Week 68.
|
Apremilast 30mg BID (Weeks 0-68)
n=120 participants at risk
Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 up until Week 68
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
1.2%
1/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
1.2%
1/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
1.7%
2/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
1.2%
1/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Infections and infestations
Pneumonia
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
1.2%
1/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.83%
1/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
0.00%
0/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
Other adverse events
| Measure |
Placebo (Weeks 0-16)
n=84 participants at risk
Participants initially randomized to identically matching placebo (PBO) by mouth (PO) twice a day (BID) during the Placebo-controlled Phase (Weeks 0-16).
|
Apremilast 20mg BID (Weeks 0-16)
n=85 participants at risk
Participants initially randomized to receive apremilast 20 mg BID PO during the Placebo-controlled Phase (Weeks 0-16).
|
Apremilast 30mg BID (Weeks 0-16)
n=85 participants at risk
Participants initially randomized to apremilast 30 mg BID PO during the Placebo-controlled Phase (Weeks 0-16).
|
Apremilast 20mg BID (Weeks 0-68)
n=121 participants at risk
Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 up until Week 68.
|
Apremilast 30mg BID (Weeks 0-68)
n=120 participants at risk
Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 up until Week 68
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
1/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
1.2%
1/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
7.1%
6/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
2.5%
3/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
6.7%
8/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
8.2%
7/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
9.4%
8/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
8.3%
10/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
10.0%
12/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
7/84 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
11.8%
10/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
11.8%
10/85 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
23.1%
28/121 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
29.2%
35/120 • AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
|
Additional Information
Anne McClain, Senior Manager, Clinical Trial Disclosure
Celgene Corporation
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 more than 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