| Primary | Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. | PASI 75 response is defined as having at least 75% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, were assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions was also assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition. | Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the full analysis set (FAS) which includes all randomized participants. | Posted | | Count of Participants | | Participants | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. | | OG002 | Placebo/Brodalumab | Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to <70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo. | | OG003 | Placebo/Ustekinumab | Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to <60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed >100 kg received 90 mg ustekinumab. |
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| - OG000NADue to early termination, only 2 participants completed Week 12 and therefore, no data is reported to maintain participant confidentiality.
- OG003NADue to early termination, only 2 participants completed Week 12 and therefore, no data is reported to maintain participant confidentiality.
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| Secondary | Static Physician's Global Assessment (sPGA) Score of 0 or 1, Assessed at Week 12. | The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed. | Due to early termination, data was not collected | Posted | | | | | | Week 12 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. | |
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| Secondary | sPGA Score of 0, Assessed at Week 12. | The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed. | Due to early termination, data was not collected | Posted | | | | | | Week 12 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. | | OG002 |
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| Secondary | PASI 90 Response, Assessed at Week 12. | PASI 90 response is defined as having at least 90% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition. | Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the FAS which includes all randomized participants. | Posted | | Count of Participants | | Participants | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. |
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| Secondary | PASI 100 Response, Assessed at Week 12. | PASI 100 response is defined as having at least 100% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition. | Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the FAS which includes all randomized participants. | Posted | | Count of Participants | | Participants | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. |
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| Secondary | Children's Dermatology Life Quality Index (CDLQI) Total Score of 0 or 1, Assessed at Week 12. | CDLQI consists of 10 items addressing the child's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life. | Due to early termination, data was not collected | Posted | | | | | | Week 12 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. |
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| Secondary | Family Dermatology Life Quality Index (FDLQI) Total Score of 0 or 1, Assessed at Week 12. | FDLQI consists of 10 items addressing the participant's relative perception of the impact of the participant's skin disease on various aspects of his/her quality of life over the last month such as: emotional distress, social life, job and leisure activities, physical well-being, time spent on helping the subject with e.g., treatment procedures, extra housework, and routine household expenditure. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life. | Due to early termination, data was not collected | Posted | | | | | | Week 12 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. |
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| Secondary | Overall Number of Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in subjects or clinical investigation participants administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above. | Dataset from the safety analysis set (SAS) which includes all participants who received at least 1 dose of IMP. | Posted | | Number | | Adverse events | | Up to approximately 5 months | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. |
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| Secondary | Presence of Anti-drug Antibodies, Assessed at Weeks 4, 16, and 52. | Number of participants with a positive post-baseline anti-drug antibody result at weeks 4, 16, and 52. | Due to early termination, data was not collected | Posted | | | | | | Week 4, Week 16, and Week 52 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. | | OG002 | Placebo/Brodalumab | |
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| Secondary | Serum Concentration of Interleukin-17, Assessed at Weeks 8, 12, and 52. | Number of participants with detectable levels of Interleukin-17 at weeks 8, 12, and 52. | Due to early termination, data was not collected | Posted | | | | | | Week 8, Week 12, and Week 52 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. | | OG002 | Placebo/Brodalumab | |
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| Secondary | Blood Levels of T-cell Subsets (CD4+ and CD8+), Assessed at Weeks 8, 12, and 52. | Number of participants with detectable levels of T-cell subsets at weeks 8, 12, and 52. | Due to early termination, data was not collected | Posted | | | | | | Week 8, Week 12, and Week 52 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. | | OG002 | Placebo/Brodalumab | |
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| Secondary | Serum Concentrations of Brodalumab, Assessed at Weeks 4, 8, 10, 12, 16, 22, and 52. | Number of participants with detectable levels of brodalumab at weeks 4, 8, 10, 12, 16, 22, and 52. | Due to early termination, data was not collected | Posted | | | | | | Week 4, Week 8, Week 10, Week 12, Week 16, Week 22, and Week 52 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. | | OG002 | Placebo/Brodalumab |
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| Secondary | Anti-tetanus Toxoid Antibodies ≥0.1 IU/mL, Assessed at Week 12. | Number of participants with detectable levels of anti-tetanus toxoid antibodies at weeks 12. | Due to early termination, data was not collected | Posted | | | | | | Week 12 | | | | ID | Title | Description |
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| OG000 | Brodalumab | Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. | | OG001 | Ustekinumab | Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to <60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing >100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. | | OG002 | Placebo/Brodalumab | |
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