| 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. | Measured in the intent-to-treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | percentage of participants | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | | <0.0001 | | Percentage Adjusted Difference | 21.7 | | | 2-Sided | 95 | 11.2 | 32.1 | | | | | Superiority | | |
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| 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. | Measured in the intent-to-treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | Measured in the intent-to-treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | Measured in the intent-to-treat (ITT) population, which included all participants who were randomized. | Posted | | Mean | Standard Error | percentage change | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | Measured in the intent-to-treat (ITT) population, which included all participants who were randomized. | Posted | | Mean | Standard Error | percentage change in affected BSA | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | Measured in participants in the intent-to-treat (ITT) population (which included all participants who were randomized), with a baseline CDLQI Score >/= 2. | Posted | | Number | | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | Measured in the intent-to-treat (ITT) population, which included all participants who were randomized. | Posted | | Mean | Standard Error | scores on a scale | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | Apremilast 20mg | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. | | OG001 | Apremilast Exposure Period: Apremilast 30 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | Apremilast 20mg | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | Apremilast 20mg | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG002 |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. | | OG001 | Apremilast Exposure Period: Apremilast 30 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Up to approximately 113 days | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Day 1 up to approximately 365 days | | | | ID | Title | Description |
|---|
| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. | | OG001 | Apremilast Exposure Period: Apremilast 30 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Up to approximately 113 days | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Day 1 up to approximately 365 days | | | | ID | Title | Description |
|---|
| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. | | OG001 | Apremilast Exposure Period: Apremilast 30 mg BID | |
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| 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. | Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Week 16 to Week 52 | | | | ID | Title | Description |
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| OG000 | Apremilast-extension Phase: Apremilast 20 mg BID | At Week 16, participants 20 to < 50 kg received apremilast 20 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. | | OG001 | Apremilast-extension Phase: Apremilast 30 mg BID | At Week 16, 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Apremilast | |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Apremilast | |
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| Secondary | Mean Body Weight of Participants During the Placebo-controlled Phase | The participants' body weight in kilograms (kg) was recorded. | Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. | Posted | | Mean | Standard Deviation | kg | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| Secondary | Mean Body Weight of Participants During the Apremilast Exposure Period | The participants' body weight in kilograms (kg) was recorded. | Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. | Posted | | Mean | Standard Deviation | kg | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. | | OG001 | Apremilast Exposure Period: Apremilast 30 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase 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. |
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| Secondary | Mean Height of Participants During the Placebo-controlled Phase | The participants' height in centimeters (cm) was recorded. | Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. | Posted | | Mean | Standard Deviation | cm | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| Secondary | Mean Height of Participants During the Apremilast Exposure Period | The participants' height in centimeters (cm) was recorded. | Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. | Posted | | Mean | Standard Deviation | cm | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. | | OG001 | Apremilast Exposure Period: Apremilast 30 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase 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. |
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| 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). | Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| Secondary | Mean BMI of Participants During the Apremilast Exposure Period | The participants' BMI was calculated as body weight (kg)/height (m^2). | Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. | | OG001 | Apremilast Exposure Period: Apremilast 30 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase 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. |
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| 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. | Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
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| OG000 | 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 who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. | | OG001 | 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. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 52 weeks | | | | ID | Title | Description |
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| OG000 | Apremilast Exposure Period: Apremilast 20 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase 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. | | OG001 | Apremilast Exposure Period: Apremilast 30 mg BID | Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants who received placebo in the placebo-controlled phase who entered the 14-week observational follow up. | | OG001 | Apremilast 20 mg BID | Participants who received apremilast 20 mg in either the placebo-controlled phase or apremilast extension phase who entered the 14-week observational follow up. | | OG002 | Apremilast 30 mg BID | Participants who received apremilast 30 mg in either the placebo-controlled phase or apremilast extension phase who entered the 14-week observational follow up. |
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