Psoriasis
Conditions
Keywords
Pediatric, 6 through 17 years, Plaque Psoriasis, Psoriasis, CC-10004, Apremilast, Otezla, Children, Adolescents, SPROUT
Brief summary
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis. At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Detailed description
Treatment will be assigned by weight with subjects 20 kg to \< 50 kg receiving apremilast 20 mg BID or placebo BID and subjects ≥ 50 kg receiving apremilast 30 mg BID or placebo BID. Total study duration is up to 71 weeks. Subjects completing all 52 weeks of the treatment and extension phase will be able to enter the Long-term study. Subjects not entering the Long-term study will return for 3 observational follow-up visits, 4, 8 and 14 weeks after last dose of study drug.
Interventions
Apremilast (CC-10004)
OTHERPlacebo
Placebo
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian 2. Subjects must have a weight of ≥ 20 kg 3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening. 4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by: * PASI score ≥ 12; and * Body surface area (BSA) ≥ 10%; and * sPGA ≥ 3 (moderate to severe) 5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis 6. Candidate for systemic therapy or phototherapy
Exclusion criteria
1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline 2. Psoriasis flare or rebound within 4 weeks prior to Screening 3. Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent 4. Answer Yes to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline 5. Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol) Exceptions\*: i. Low potency or weak corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae and groin in accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions \*Subjects should not use these topical treatments within 24 hours prior to the clinic visit. b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization c. Phototherapy treatment (ie, ultraviolet B \[UVB\], PUVA) within 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 | Baseline to Week 16 | The sPGA is the assessment by the Investigator of the overall disease severity of plaque psoriasis at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. The results presented are for the percentage of participants with a sPGA response. An sPGA response was defined as a score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) From Baseline at Week 16 | Baseline and Week 16 | The Psoriasis Area Severity Index (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 scores range from 0 to 72, with higher scores reflecting greater disease severity. The results presented are for the percentage of participants with PASI-75. PASI-75 was defined as at least a 75% reduction in PASI score from baseline. |
| Percentage Change From Baseline in Total PASI Score at Week 16 | Baseline and Week 16 | 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 scores range from 0 to 72, with higher scores reflecting greater disease severity. Positive percentage change from baseline scores indicate a worsening of disease severity, and negative percentage change from baseline scores indicate an improvement in disease severity. |
| Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 | Baseline and Week 16 | BSA is a measurement of involved skin of the whole body affected by psoriasis, which ranges from 0% to 100%. Positive percentage change from baseline indicates that a greater BSA was affected by psoriasis. A negative percentage change from baseline indicates that a lesser BSA was affected by psoriasis. |
| Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 | Week 16 | The CDLQI is designed to measure the impact of skin disease on children's quality of life. The CDLQI measures how much the participant's psoriasis has affected them over the last week, and includes 10 questions with possible answers ranging from not at all (score of 0) to very much (score of 3). The CDLQI total score ranged from 0 (no effect on the participant's life) to 30 (extremely large effect on the participant's life). The results presented are for the percentage of participants who achieved a total CDLQI score of 0 or 1 at Week 16. |
| Change From Baseline in CDLQI Score at Week 16 | Baseline and Week 16 | The CDLQI is designed to measure the impact of skin disease on children's quality of life. The CDLQI measures how much the participant's psoriasis has affected them over the last week, and includes 10 questions with possible answers ranging from not at all (score of 0) to very much (score of 3). The CDLQI total score ranged from 0 (no effect on the participant's life) to 30 (extremely large effect on the participant's life). A positive change from baseline score indicates that a participant's quality of life has worsened. A negative change from baseline score indicates that a participant's quality of life has improved. |
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase | 16 weeks | An adverse event (AE) was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of the study. A TEAE is any AE that occurred after first dose of the investigational product. |
| Number of Participants Who Experienced a TEAE During the Apremilast Exposure Period | 52 weeks | An AE was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of the study. A TEAE is any AE that occurred after first dose of the investigational product. |
| Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase | 16 weeks | A TESAE is any AE occurring at any dose after first dose that results in death, is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE), requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay), results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions), is a congenital anomaly/birth defect, or constitutes an important medical event. |
| Number of Participants Who Experienced a TESAE During the Apremilast Exposure Period | 52 weeks | A TESAE is any AE occurring at any dose after first dose that results in death, is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE), requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay), results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions), is a congenital anomaly/birth defect, or constitutes an important medical event. |
| Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase | 16 weeks | A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product. |
| Number of Participants Who Experienced a TRAE During the Apremilast Exposure Period | 52 weeks | A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product. |
| Number of Participants With Diarrhea During the Placebo-controlled Phase | Up to approximately 113 days | Diarrhea was defined as having 3 or more liquid or watery stools in a day. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms. |
| Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 1 up to approximately 365 days | Diarrhea was defined as having 3 or more liquid or watery stools in a day. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms. |
| Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Up to approximately 113 days | Diarrhea symptoms were nausea, vomiting, abdominal cramps, abdominal pain, fever, bloating, and other symptoms. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms. |
| Percentage of Participants Who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) From Baseline at Week 16 | Baseline and Week 16 | 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 scores range from 0 to 72, with higher scores reflecting greater disease severity. The results presented are for the percentage of participants with PASI-50. PASI-50 was defined as at least a 50% reduction in PASI score from baseline. |
| Number of Participants With Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase | 16 weeks | The C-SSRS is a questionnaire that is used to assess suicidal ideation and behavior. The C-SSRS questionnaire measures suicidal ideation, intensity of ideation, and suicidal behaviors. Results presented are for the number of participants who recorded suicidal ideation or behavior on the C-SSRS. |
| Number of Participants With Suicidal Ideation or Behavior Per the C-SSRS During the Apremilast-extension Phase | Week 16 to Week 52 | The C-SSRS is a questionnaire that is used to assess suicidal ideation and behavior. The C-SSRS questionnaire measures suicidal ideation, intensity of ideation, and suicidal behaviors. Results presented are for the number of participants who recorded suicidal ideation or behavior on the C-SSRS. |
| Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Week 52 | The Tanner Staging of sexual development is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on characteristics, such as the size of the breasts, genitals, testicular volume, and growth of pubic hair. The scale ranges from stage I (pre-adolescent) to stage V (adult development). The results presented are for the number of participants at stage I-V of development. |
| Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase | Baseline and Week 16 | The participants' BMI was calculated as body weight (kg)/height (m\^2). |
| Mean BMI of Participants During the Apremilast Exposure Period | Baseline and Week 52 | The participants' BMI was calculated as body weight (kg)/height (m\^2). |
| Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Week 52 | The Tanner Staging of sexual development is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on characteristics, such as the size of the breasts, genitals, testicular volume, and growth of pubic hair. The scale ranges from stage I (pre-adolescent) to stage V (adult development). The results presented are for the number of participants at stage I-V of development. |
| Mean Body Weight of Participants During the Placebo-controlled Phase | Baseline and Week 16 | The participants' body weight in kilograms (kg) was recorded. |
| Number of Participants Who Experienced a Psoriasis Flare During the Placebo-controlled Phase | 16 weeks | A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications. |
| Mean Body Weight of Participants During the Apremilast Exposure Period | Baseline and Week 52 | The participants' body weight in kilograms (kg) was recorded. |
| Mean Height of Participants During the Placebo-controlled Phase | Baseline and Week 16 | The participants' height in centimeters (cm) was recorded. |
| Mean Height of Participants During the Apremilast Exposure Period | Baseline and Week 52 | The participants' height in centimeters (cm) was recorded. |
| Number of Participants Who Experienced a Psoriasis Flare During the Apremilast Exposure Period | 52 weeks | A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications. |
| Number of Participants Who Experienced a Psoriasis Rebound | 14 weeks post last dose (max mean treatment duration in placebo-controlled phase was 15.3 weeks, and 41.9 weeks in the apremilast-exposure period) | A psoriasis rebound was defined as an adverse event of psoriasis that started after the last dose date for participants who received treatment in the study. |
| Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 up to approximately 365 days | Diarrhea symptoms were nausea, vomiting, abdominal cramps, abdominal pain, fever, bloating, and other symptoms. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms. |
Countries
Belgium, Canada, Czechia, France, Israel, Italy, Netherlands, Russia, Spain, United States
Participant flow
Recruitment details
Participants were enrolled into this study at sites in Belgium, Canada, Czech Republic, France, Israel, Italy, Russia, Spain, and the United States.
Pre-assignment details
Screening tests and procedures were performed up to 35 days preceding randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants 20 to \< 50 kg received apremilast 20 mg BID for 36 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | 82 |
| Apremilast In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. At Week 16, participants in the apremilast group continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | 163 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 14-Week Observational Follow-up Phase | Lost to Follow-up | 0 | 0 | 0 | 1 |
| 14-Week Observational Follow-up Phase | Miscellaneous | 0 | 0 | 1 | 0 |
| 14-Week Observational Follow-up Phase | Other | 0 | 0 | 1 | 0 |
| 14-Week Observational Follow-up Phase | Withdrawal by Parent/Guardian | 0 | 1 | 1 | 0 |
| 14-Week Observational Follow-up Phase | Withdrawal by Subject | 0 | 0 | 0 | 2 |
| Apremilast Extension Phase | Adverse Event | 0 | 0 | 3 | 1 |
| Apremilast Extension Phase | Lack of Efficacy | 0 | 0 | 3 | 8 |
| Apremilast Extension Phase | Lost to Follow-up | 0 | 0 | 0 | 2 |
| Apremilast Extension Phase | Miscellaneous | 0 | 0 | 2 | 1 |
| Apremilast Extension Phase | Non-compliance with Study Drug | 0 | 0 | 1 | 1 |
| Apremilast Extension Phase | Withdrawal by Parent/Guardian | 0 | 0 | 1 | 8 |
| Apremilast Extension Phase | Withdrawal by Subject | 0 | 0 | 1 | 3 |
| Placebo-controlled Phase | Adverse Event | 1 | 5 | 0 | 0 |
| Placebo-controlled Phase | Lack of Efficacy | 2 | 0 | 0 | 0 |
| Placebo-controlled Phase | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Placebo-controlled Phase | Miscellaneous | 2 | 0 | 0 | 0 |
| Placebo-controlled Phase | Withdrawal by Parent/Guardian | 3 | 5 | 0 | 0 |
| Placebo-controlled Phase | Withdrawal by Subject | 2 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Apremilast | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 12.3 years STANDARD_DEVIATION 3.32 | 12.2 years STANDARD_DEVIATION 3.29 | 12.2 years STANDARD_DEVIATION 3.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 32 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 129 Participants | 200 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 13 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 13 Participants | 3 Participants |
| Race (NIH/OMB) White | 140 Participants | 213 Participants | 73 Participants |
| Sex: Female, Male Female | 89 Participants | 128 Participants | 39 Participants |
| Sex: Female, Male Male | 74 Participants | 117 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 80 | 0 / 83 | 0 / 163 | 0 / 110 | 0 / 111 | 0 / 221 |
| other Total, other adverse events | 26 / 80 | 50 / 80 | 41 / 83 | 91 / 163 | 52 / 110 | 38 / 111 | 90 / 221 |
| serious Total, serious adverse events | 1 / 80 | 2 / 80 | 0 / 83 | 2 / 163 | 0 / 110 | 2 / 111 | 2 / 221 |
Outcome results
Primary
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16
The sPGA is the assessment by the Investigator of the overall disease severity of plaque psoriasis at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. The results presented are for the percentage of participants with a sPGA response. An sPGA response was defined as a score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16.
Time frame: Baseline to Week 16
Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 | 11.5 percentage of participants |
| Apremilast | Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 | 33.1 percentage of participants |
p-value: <0.000195% CI: [11.2, 32.1]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in CDLQI Score at Week 16
The CDLQI is designed to measure the impact of skin disease on children's quality of life. The CDLQI measures how much the participant's psoriasis has affected them over the last week, and includes 10 questions with possible answers ranging from not at all (score of 0) to very much (score of 3). The CDLQI total score ranged from 0 (no effect on the participant's life) to 30 (extremely large effect on the participant's life). A positive change from baseline score indicates that a participant's quality of life has worsened. A negative change from baseline score indicates that a participant's quality of life has improved.
Time frame: Baseline and Week 16
Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in CDLQI Score at Week 16 | -2.7 scores on a scale | Standard Error 0.56 |
| Apremilast | Change From Baseline in CDLQI Score at Week 16 | -5.3 scores on a scale | Standard Error 0.44 |
p-value: 0.000995% CI: [-2.9, -0.8]ANCOVA
Secondary
Mean BMI of Participants During the Apremilast Exposure Period
The participants' BMI was calculated as body weight (kg)/height (m\^2).
Time frame: Baseline and Week 52
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean BMI of Participants During the Apremilast Exposure Period | Baseline | 18.32 kg/m^2 | Standard Deviation 2.641 |
| Placebo | Mean BMI of Participants During the Apremilast Exposure Period | Week 52 | 18.30 kg/m^2 | Standard Deviation 2.48 |
| Apremilast | Mean BMI of Participants During the Apremilast Exposure Period | Baseline | 24.52 kg/m^2 | Standard Deviation 5.655 |
| Apremilast | Mean BMI of Participants During the Apremilast Exposure Period | Week 52 | 23.95 kg/m^2 | Standard Deviation 5.539 |
Secondary
Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase
The participants' BMI was calculated as body weight (kg)/height (m\^2).
Time frame: Baseline and Week 16
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase | Baseline | 21.41 kg/m^2 | Standard Deviation 5.652 |
| Placebo | Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase | Week 16 | 21.87 kg/m^2 | Standard Deviation 5.883 |
| Apremilast | Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase | Baseline | 21.33 kg/m^2 | Standard Deviation 5.197 |
| Apremilast | Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase | Week 16 | 20.98 kg/m^2 | Standard Deviation 5.067 |
Secondary
Mean Body Weight of Participants During the Apremilast Exposure Period
The participants' body weight in kilograms (kg) was recorded.
Time frame: Baseline and Week 52
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Body Weight of Participants During the Apremilast Exposure Period | Baseline | 36.81 kg | Standard Deviation 8.954 |
| Placebo | Mean Body Weight of Participants During the Apremilast Exposure Period | Week 52 | 39.04 kg | Standard Deviation 9.823 |
| Apremilast | Mean Body Weight of Participants During the Apremilast Exposure Period | Baseline | 67.94 kg | Standard Deviation 19.053 |
| Apremilast | Mean Body Weight of Participants During the Apremilast Exposure Period | Week 52 | 67.79 kg | Standard Deviation 18.889 |
Secondary
Mean Body Weight of Participants During the Placebo-controlled Phase
The participants' body weight in kilograms (kg) was recorded.
Time frame: Baseline and Week 16
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Body Weight of Participants During the Placebo-controlled Phase | Baseline | 52.36 kg | Standard Deviation 22.177 |
| Placebo | Mean Body Weight of Participants During the Placebo-controlled Phase | Week 16 | 54.18 kg | Standard Deviation 22.581 |
| Apremilast | Mean Body Weight of Participants During the Placebo-controlled Phase | Baseline | 52.04 kg | Standard Deviation 21.123 |
| Apremilast | Mean Body Weight of Participants During the Placebo-controlled Phase | Week 16 | 51.95 kg | Standard Deviation 20.945 |
Secondary
Mean Height of Participants During the Apremilast Exposure Period
The participants' height in centimeters (cm) was recorded.
Time frame: Baseline and Week 52
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Height of Participants During the Apremilast Exposure Period | Baseline | 140.86 cm | Standard Deviation 14.159 |
| Placebo | Mean Height of Participants During the Apremilast Exposure Period | Week 52 | 144.90 cm | Standard Deviation 13.944 |
| Apremilast | Mean Height of Participants During the Apremilast Exposure Period | Baseline | 166.13 cm | Standard Deviation 11.416 |
| Apremilast | Mean Height of Participants During the Apremilast Exposure Period | Week 52 | 167.84 cm | Standard Deviation 10.814 |
Secondary
Mean Height of Participants During the Placebo-controlled Phase
The participants' height in centimeters (cm) was recorded.
Time frame: Baseline and Week 16
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Height of Participants During the Placebo-controlled Phase | Baseline | 153.29 cm | Standard Deviation 18.435 |
| Placebo | Mean Height of Participants During the Placebo-controlled Phase | Week 16 | 154.54 cm | Standard Deviation 17.839 |
| Apremilast | Mean Height of Participants During the Placebo-controlled Phase | Baseline | 153.33 cm | Standard Deviation 18.069 |
| Apremilast | Mean Height of Participants During the Placebo-controlled Phase | Week 16 | 154.40 cm | Standard Deviation 17.683 |
Secondary
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
The Tanner Staging of sexual development is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on characteristics, such as the size of the breasts, genitals, testicular volume, and growth of pubic hair. The scale ranges from stage I (pre-adolescent) to stage V (adult development). The results presented are for the number of participants at stage I-V of development.
Time frame: Week 52
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product and had available data for the endpoint. As pre-specified, results are presented based on initial treatment received.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 1 | 8 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 2 | 3 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 3 | 3 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 4 | 6 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 5 | 12 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Missing | 5 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 1 | 8 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 2 | 3 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 3 | 3 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 4 | 6 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 5 | 12 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Missing | 5 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 1 | 8 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 2 | 3 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 3 | 3 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 4 | 4 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 5 | 12 Participants |
| Placebo | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Missing | 7 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 2 | 9 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 1 | 17 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 4 | 18 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 2 | 9 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Missing | 8 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 3 | 9 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 5 | 28 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 4 | 20 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 3 | 12 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Stage 5 | 27 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Missing | 7 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Breast Growth | Missing | 7 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 5 | 26 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 1 | 18 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 1 | 18 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 2 | 9 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 4 | 16 Participants |
| Apremilast | Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 3 | 9 Participants |
Secondary
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
The Tanner Staging of sexual development is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on characteristics, such as the size of the breasts, genitals, testicular volume, and growth of pubic hair. The scale ranges from stage I (pre-adolescent) to stage V (adult development). The results presented are for the number of participants at stage I-V of development.
Time frame: Week 52
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product and had available data for the endpoint. As pre-specified, results are presented based on initial treatment received.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 1 | 11 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 2 | 5 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 3 | 4 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 4 | 5 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 5 | 14 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Missing | 4 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 1 | 11 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 2 | 5 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 3 | 4 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 4 | 5 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 5 | 14 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Missing | 4 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 1 | 10 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 2 | 5 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 3 | 5 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 4 | 6 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 5 | 13 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Missing | 4 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 1 | 9 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 2 | 5 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 3 | 4 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 4 | 4 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 5 | 14 Participants |
| Placebo | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Missing | 7 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 5 | 26 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 1 | 15 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 1 | 15 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 2 | 5 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 1 | 15 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 3 | 10 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 2 | 6 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 4 | 12 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 4 | 11 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Stage 5 | 27 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 3 | 8 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Testes Growth | Missing | 5 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 2 | 5 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 1 | 15 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 4 | 14 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 2 | 5 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Missing | 9 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 3 | 11 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Stage 5 | 26 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 4 | 10 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Other Changes | Stage 3 | 8 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Stage 5 | 28 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Pubic Hair Growth | Missing | 5 Participants |
| Apremilast | Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development | Penis Growth | Missing | 5 Participants |
Secondary
Number of Participants Who Experienced a Psoriasis Flare During the Apremilast Exposure Period
A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications.
Time frame: 52 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-defined in the statistical analysis plan, data are presented per treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Psoriasis Flare During the Apremilast Exposure Period | 7 Participants |
| Apremilast | Number of Participants Who Experienced a Psoriasis Flare During the Apremilast Exposure Period | 11 Participants |
Secondary
Number of Participants Who Experienced a Psoriasis Flare During the Placebo-controlled Phase
A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications.
Time frame: 16 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Psoriasis Flare During the Placebo-controlled Phase | 3 Participants |
| Apremilast | Number of Participants Who Experienced a Psoriasis Flare During the Placebo-controlled Phase | 2 Participants |
Secondary
Number of Participants Who Experienced a Psoriasis Rebound
A psoriasis rebound was defined as an adverse event of psoriasis that started after the last dose date for participants who received treatment in the study.
Time frame: 14 weeks post last dose (max mean treatment duration in placebo-controlled phase was 15.3 weeks, and 41.9 weeks in the apremilast-exposure period)
Population: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product) who entered the 14-week observational follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Psoriasis Rebound | 0 Participants |
| Apremilast | Number of Participants Who Experienced a Psoriasis Rebound | 0 Participants |
| Apremilast 30 mg | Number of Participants Who Experienced a Psoriasis Rebound | 4 Participants |
Secondary
Number of Participants Who Experienced a TEAE During the Apremilast Exposure Period
An AE was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of the study. A TEAE is any AE that occurred after first dose of the investigational product.
Time frame: 52 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-defined in the statistical analysis plan, data are presented per treatment received and adverse event data collected by apremilast dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a TEAE During the Apremilast Exposure Period | 88 Participants |
| Apremilast | Number of Participants Who Experienced a TEAE During the Apremilast Exposure Period | 80 Participants |
Secondary
Number of Participants Who Experienced a TESAE During the Apremilast Exposure Period
A TESAE is any AE occurring at any dose after first dose that results in death, is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE), requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay), results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions), is a congenital anomaly/birth defect, or constitutes an important medical event.
Time frame: 52 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-defined in the statistical analysis plan, data are presented per treatment received and adverse event data collected by apremilast dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a TESAE During the Apremilast Exposure Period | 2 Participants |
| Apremilast | Number of Participants Who Experienced a TESAE During the Apremilast Exposure Period | 1 Participants |
Secondary
Number of Participants Who Experienced a TRAE During the Apremilast Exposure Period
A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.
Time frame: 52 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-defined in the statistical analysis plan, data are presented per treatment received and adverse event data collected by apremilast dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a TRAE During the Apremilast Exposure Period | 45 Participants |
| Apremilast | Number of Participants Who Experienced a TRAE During the Apremilast Exposure Period | 47 Participants |
Secondary
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase
An adverse event (AE) was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of the study. A TEAE is any AE that occurred after first dose of the investigational product.
Time frame: 16 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received and adverse event data collected by apremilast dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase | 33 Participants |
| Apremilast | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase | 58 Participants |
| Apremilast 30 mg | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase | 48 Participants |
Secondary
Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase
A TESAE is any AE occurring at any dose after first dose that results in death, is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE), requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay), results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions), is a congenital anomaly/birth defect, or constitutes an important medical event.
Time frame: 16 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received and adverse event data collected by apremilast dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase | 1 Participants |
| Apremilast | Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase | 2 Participants |
| Apremilast 30 mg | Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase | 0 Participants |
Secondary
Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase
A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.
Time frame: 16 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received and adverse event data collected by apremilast dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase | 12 Participants |
| Apremilast | Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase | 36 Participants |
| Apremilast 30 mg | Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase | 32 Participants |
Secondary
Number of Participants With Diarrhea During the Apremilast Exposure Period
Diarrhea was defined as having 3 or more liquid or watery stools in a day. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
Time frame: Day 1 up to approximately 365 days
Population: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product), who had diary entries at each specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 1 to 28 | 36 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 29 to 56 | 30 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 57 to 84 | 22 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 85 to 112 | 17 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 113 to 140 | 21 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 141 to 168 | 16 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 169 to 196 | 19 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 197 to 224 | 19 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 225 to 252 | 20 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 253 to 280 | 18 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 281 to 308 | 13 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 309 to 336 | 12 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 337 to 364 | 7 Participants |
| Placebo | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day >= 365 | 1 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 281 to 308 | 9 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 1 to 28 | 47 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 197 to 224 | 12 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 29 to 56 | 36 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 337 to 364 | 5 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 57 to 84 | 32 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 225 to 252 | 12 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 85 to 112 | 19 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 309 to 336 | 5 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 113 to 140 | 17 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 253 to 280 | 16 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 141 to 168 | 21 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day >= 365 | 1 Participants |
| Apremilast | Number of Participants With Diarrhea During the Apremilast Exposure Period | Day 169 to 196 | 17 Participants |
Secondary
Number of Participants With Diarrhea During the Placebo-controlled Phase
Diarrhea was defined as having 3 or more liquid or watery stools in a day. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
Time frame: Up to approximately 113 days
Population: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product), who had diary entries at each specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day 29 to 56 | 20 Participants |
| Placebo | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day 85 to 112 | 10 Participants |
| Placebo | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day 57 to 84 | 14 Participants |
| Placebo | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day >/= 113 | 2 Participants |
| Placebo | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day 1 to 28 | 25 Participants |
| Apremilast | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day >/= 113 | 9 Participants |
| Apremilast | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day 1 to 28 | 67 Participants |
| Apremilast | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day 29 to 56 | 51 Participants |
| Apremilast | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day 57 to 84 | 41 Participants |
| Apremilast | Number of Participants With Diarrhea During the Placebo-controlled Phase | Day 85 to 112 | 29 Participants |
Secondary
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Diarrhea symptoms were nausea, vomiting, abdominal cramps, abdominal pain, fever, bloating, and other symptoms. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
Time frame: Day 1 up to approximately 365 days
Population: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product), who had diary entries at each specified time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Fever | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Vomiting | 10 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Abdominal cramps | 7 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Abdominal pain | 21 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Fever | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Bloating | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Other symptoms | 11 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | No symptoms | 38 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Nausea | 14 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Vomiting | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Abdominal cramps | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Abdominal pain | 13 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Fever | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Bloating | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Other symptoms | 9 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | No symptoms | 59 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Nausea | 6 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Vomiting | 6 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Abdominal cramps | 8 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Abdominal pain | 10 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Fever | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Bloating | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Other symptoms | 10 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | No symptoms | 59 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Nausea | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Vomiting | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Abdominal cramps | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Abdominal pain | 6 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Nausea | 17 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Bloating | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Other symptoms | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | No symptoms | 76 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Nausea | 6 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Vomiting | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Abdominal cramps | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Abdominal pain | 7 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Fever | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Bloating | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Other symptoms | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | No symptoms | 68 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Nausea | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Vomiting | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Abdominal cramps | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Abdominal pain | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Bloating | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Other symptoms | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | No symptoms | 79 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Nausea | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Vomiting | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Abdominal cramps | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Abdominal pain | 7 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Bloating | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Other symptoms | 7 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | No symptoms | 76 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Nausea | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Vomiting | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Abdominal cramps | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Abdominal pain | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Fever | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Bloating | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Other symptoms | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | No symptoms | 72 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Nausea | 9 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Vomiting | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Abdominal cramps | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Abdominal pain | 7 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Bloating | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Other symptoms | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | No symptoms | 64 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Nausea | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Vomiting | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Abdominal cramps | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Abdominal pain | 6 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Fever | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Bloating | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Other symptoms | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | No symptoms | 55 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Nausea | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Vomiting | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Abdominal cramps | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Abdominal pain | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Bloating | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Other symptoms | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | No symptoms | 52 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Nausea | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Vomiting | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Abdominal cramps | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Abdominal pain | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Fever | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Bloating | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Other symptoms | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | No symptoms | 47 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Nausea | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Vomiting | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Abdominal cramps | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Abdominal pain | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Bloating | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Other symptoms | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | No symptoms | 52 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Nausea | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Vomiting | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Abdominal cramps | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Abdominal pain | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Bloating | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Other symptoms | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | No symptoms | 24 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Nausea | 21 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Nausea | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Vomiting | 4 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Abdominal cramps | 9 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Vomiting | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Abdominal pain | 14 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Abdominal cramps | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Fever | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Abdominal cramps | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Bloating | 7 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Bloating | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | Other symptoms | 13 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Abdominal pain | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 1 to 28 | No symptoms | 43 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Vomiting | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Nausea | 10 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Vomiting | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Other symptoms | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Abdominal cramps | 4 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Bloating | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Abdominal pain | 8 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Abdominal pain | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | Other symptoms | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Bloating | 9 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | No symptoms | 49 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | Other symptoms | 9 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 197 to 224 | No symptoms | 97 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 29 to 56 | No symptoms | 70 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Other symptoms | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Nausea | 8 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Nausea | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Vomiting | 4 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Nausea | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Abdominal cramps | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Vomiting | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Abdominal pain | 6 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Fever | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Abdominal cramps | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Bloating | 6 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Vomiting | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | Other symptoms | 6 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Abdominal pain | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 57 to 84 | No symptoms | 76 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Abdominal cramps | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Nausea | 5 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Vomiting | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Abdominal cramps | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Abdominal cramps | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Bloating | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Abdominal pain | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Bloating | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Fever | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | Other symptoms | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Bloating | 4 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Abdominal pain | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | Other symptoms | 4 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 225 to 252 | No symptoms | 92 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 85 to 112 | No symptoms | 86 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Bloating | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Nausea | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Nausea | 4 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Vomiting | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Abdominal cramps | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Vomiting | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Abdominal pain | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Other symptoms | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Abdominal cramps | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Bloating | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Bloating | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | Other symptoms | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Abdominal pain | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 113 to 140 | No symptoms | 95 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Abdominal pain | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Nausea | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Vomiting | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | Other symptoms | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Abdominal cramps | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Bloating | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Abdominal pain | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | No symptoms | 54 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | Other symptoms | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Bloating | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 309 to 336 | No symptoms | 57 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | Other symptoms | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 253 to 280 | No symptoms | 58 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 141 to 168 | No symptoms | 95 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | No symptoms | 21 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Nausea | 4 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Nausea | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Vomiting | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Nausea | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Abdominal cramps | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Vomiting | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Abdominal pain | 5 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day >= 365 | Nausea | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Fever | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Abdominal cramps | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Bloating | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 337 to 364 | Vomiting | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | Other symptoms | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 281 to 308 | Abdominal pain | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period | Day 169 to 196 | No symptoms | 87 Participants |
Secondary
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Diarrhea symptoms were nausea, vomiting, abdominal cramps, abdominal pain, fever, bloating, and other symptoms. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
Time frame: Up to approximately 113 days
Population: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product), who had diary entries at each specified time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Abdominal cramps | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Vomiting | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Abdominal cramps | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Abdominal pain | 9 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Fever | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Bloating | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Other symptoms | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | No symptoms | 53 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Nausea | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Vomiting | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Nausea | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Abdominal pain | 9 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Bloating | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Other symptoms | 4 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | No symptoms | 56 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Nausea | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Vomiting | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Abdominal cramps | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Abdominal pain | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Bloating | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Other symptoms | 6 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | No symptoms | 65 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Nausea | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Vomiting | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Abdominal cramps | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Abdominal pain | 2 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Bloating | 3 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Other symptoms | 5 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | No symptoms | 66 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Nausea | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Vomiting | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Abdominal cramps | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Abdominal pain | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Fever | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Bloating | 1 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Other symptoms | 0 Participants |
| Placebo | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | No symptoms | 79 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Bloating | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Nausea | 32 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Fever | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Vomiting | 13 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Other symptoms | 8 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Abdominal cramps | 16 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Bloating | 6 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Abdominal pain | 28 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Abdominal pain | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Fever | 5 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Other symptoms | 11 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Bloating | 8 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | No symptoms | 125 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | Other symptoms | 21 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | No symptoms | 103 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 1 to 28 | No symptoms | 33 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | No symptoms | 154 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Nausea | 22 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Nausea | 8 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Vomiting | 6 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Nausea | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Abdominal cramps | 7 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Vomiting | 3 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Abdominal pain | 17 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Fever | 0 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Fever | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Abdominal cramps | 5 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Bloating | 12 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Vomiting | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | Other symptoms | 17 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Abdominal pain | 7 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 29 to 56 | No symptoms | 81 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Other symptoms | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Nausea | 12 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Fever | 2 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Vomiting | 7 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day >/= 113 | Abdominal cramps | 1 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Abdominal cramps | 9 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 85 to 112 | Bloating | 5 Participants |
| Apremilast | Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase | Day 57 to 84 | Abdominal pain | 13 Participants |
Secondary
Number of Participants With Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase
The C-SSRS is a questionnaire that is used to assess suicidal ideation and behavior. The C-SSRS questionnaire measures suicidal ideation, intensity of ideation, and suicidal behaviors. Results presented are for the number of participants who recorded suicidal ideation or behavior on the C-SSRS.
Time frame: 16 weeks
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase | 0 Participants |
| Apremilast | Number of Participants With Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase | 0 Participants |
Secondary
Number of Participants With Suicidal Ideation or Behavior Per the C-SSRS During the Apremilast-extension Phase
The C-SSRS is a questionnaire that is used to assess suicidal ideation and behavior. The C-SSRS questionnaire measures suicidal ideation, intensity of ideation, and suicidal behaviors. Results presented are for the number of participants who recorded suicidal ideation or behavior on the C-SSRS.
Time frame: Week 16 to Week 52
Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product who had available C-SSRS data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Suicidal Ideation or Behavior Per the C-SSRS During the Apremilast-extension Phase | 0 Participants |
| Apremilast | Number of Participants With Suicidal Ideation or Behavior Per the C-SSRS During the Apremilast-extension Phase | 0 Participants |
Secondary
Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16
BSA is a measurement of involved skin of the whole body affected by psoriasis, which ranges from 0% to 100%. Positive percentage change from baseline indicates that a greater BSA was affected by psoriasis. A negative percentage change from baseline indicates that a lesser BSA was affected by psoriasis.
Time frame: Baseline and Week 16
Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 | -20.56 percentage change in affected BSA | Standard Error 5.441 |
| Apremilast | Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 | -55.44 percentage change in affected BSA | Standard Error 3.428 |
p-value: <0.000195% CI: [-46.99, -22.55]ANCOVA
Secondary
Percentage Change From Baseline in Total PASI Score at Week 16
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 scores range from 0 to 72, with higher scores reflecting greater disease severity. Positive percentage change from baseline scores indicate a worsening of disease severity, and negative percentage change from baseline scores indicate an improvement in disease severity.
Time frame: Baseline and Week 16
Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage Change From Baseline in Total PASI Score at Week 16 | -37.49 percentage change | Standard Error 3.866 |
| Apremilast | Percentage Change From Baseline in Total PASI Score at Week 16 | -64.52 percentage change | Standard Error 2.543 |
p-value: <0.000195% CI: [-35.93, -18]ANCOVA
Secondary
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16
The CDLQI is designed to measure the impact of skin disease on children's quality of life. The CDLQI measures how much the participant's psoriasis has affected them over the last week, and includes 10 questions with possible answers ranging from not at all (score of 0) to very much (score of 3). The CDLQI total score ranged from 0 (no effect on the participant's life) to 30 (extremely large effect on the participant's life). The results presented are for the percentage of participants who achieved a total CDLQI score of 0 or 1 at Week 16.
Time frame: Week 16
Population: Measured in participants in the intent-to-treat (ITT) population (which included all participants who were randomized), with a baseline CDLQI Score \>/= 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 | 31.3 percentage of participants |
| Apremilast | Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 | 35.4 percentage of participants |
p-value: 0.561695% CI: [-9.8, 18]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) From Baseline at Week 16
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 scores range from 0 to 72, with higher scores reflecting greater disease severity. The results presented are for the percentage of participants with PASI-50. PASI-50 was defined as at least a 50% reduction in PASI score from baseline.
Time frame: Baseline and Week 16
Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) From Baseline at Week 16 | 32.1 percentage of participants |
| Apremilast | Percentage of Participants Who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) From Baseline at Week 16 | 70.5 percentage of participants |
p-value: <0.000195% CI: [25.6, 51.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) From Baseline at Week 16
The Psoriasis Area Severity Index (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 scores range from 0 to 72, with higher scores reflecting greater disease severity. The results presented are for the percentage of participants with PASI-75. PASI-75 was defined as at least a 75% reduction in PASI score from baseline.
Time frame: Baseline and Week 16
Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) From Baseline at Week 16 | 16.1 percentage of participants |
| Apremilast | Percentage of Participants Who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) From Baseline at Week 16 | 45.4 percentage of participants |
p-value: <0.000195% CI: [17.8, 40.9]Cochran-Mantel-Haenszel