| Primary | Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. Treatment Failure (TF) criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | Full analysis set (FAS): all enrolled and treated participants who received at least 1 injection of ustekinumab (partial or complete). Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dose (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with >=75% improvement in PASI from baseline were considered PASI 75 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. For participants meeting one or more TF criteria, were considered to have 0 improvement from baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure at both baseline and Week 12. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percentage of Participants Who Achieved PASI 90 Response at Week 12 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72 (disease severity). A higher score indicates more severe disease. Participants with >=90% improvement in PASI from baseline were considered PASI 90 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. Participants who met 1 or more TF criteria were considered as non-responders after TF. In addition, participants with missing data at Week 12 were also considered as non-responders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 16, 28, 40, and 52 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as >=50%, >=75%, >=90%, and 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. Participants who met 1 or more TF criteria were considered as non-responders after TF. In addition, participants with missing data at Week 12 were also considered as non-responders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 16, 28, 40, and 52 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 100 responders were defined as 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. For participants meeting one or more TF criteria, were considered to have 0% improvement from baseline. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | percent change | | Baseline and Weeks 4, 8, 12, 16, 28, 40, 52 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as >=50%, >=75%, >=90%, and 100% improvement in PASI component from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. Participants meeting one or more TF criteria were considered as non-responders. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. Participants who met TF criteria prior to Week 12 were assigned 0 change. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 4, 12, 28, 52 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS with CDLQI score > 1 at baseline. Participants who met 1 or more TF criteria prior to Week 12 or with missing data were considered as nonresponders. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS with CDLQI > 1 at baseline. Participants who met 1 or more TF criteria were considered as nonresponders after TF. In addition, participants with missing data at Week 12 were considered as nonresponders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. | Posted | | Number | | percentage of participants | | Weeks 4, 12, 28, and 52 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Change From Baseline in CDLQI Component Scores at Week 12 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. | FAS. Participants who met TF criteria prior to Week 12 were assigned 0 change. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56. |
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| Secondary | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicated worse disease. | FAS; all participants enrolled in the LTE who received at least an injection of ustekinumab at Week 56 (partial or complete). Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed): participants evaluated at given timepoints. | Posted | | Number | | percentage of participants | | Weeks 80, 104, 128, 152, 176 | | | | ID | Title | Description |
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| OG000 | Ustekinumab Standard Dosage (Long-Term Extension [LTE]) | Participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a every 12 weeks (q12w) regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. |
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