Adults 4 to 17, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI 75) at Week 12Primary· Baseline and week 12
The percentage of participants who achieved 75% or greater improvement (decrease) from baseline in PASI score after 12 weeks of treatment. The PASI score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher
Group
Value
95% CI
Placebo
11.0
Etanercept
57.0
Percentage of Participants Achieving a ≥ 50% Improvement in PASI Score (PASI 50) at Week 12Secondary· Baseline and week 12
The percentage of participants who achieved 50% or greater improvement from baseline in PASI score after 12 weeks of treatment. PASI is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the
Group
Value
95% CI
Placebo
23
Etanercept
75
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) at Week 12Secondary· Week 12
The sPGA is a static measurement based on induration, erythema, and scaling. The sPGA is assessed on a scale from 0 to 5:
0 = clear (no evidence of plaque elevation, erythema or scaling)
1. = almost clear (minimal plaque elevation, erythema or scaling)
2. = mild (mild plaque elevation or scaling, light red coloration)
3. = moderate (moderate plaque elevation, scaling, light red coloration)
4. = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)
5. = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).
Par
Group
Value
95% CI
Placebo
13
Etanercept
53
Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12Secondary· Baseline and week 12
The Children's Dermatology Life Quality Index (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. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but \< 13 years old used the cartoon version of the instrument and participants ≤ 7 y
Group
Value
95% CI
Placebo
17.5
± 8.3
Etanercept
52.3
± 6.1
Percentage of Participants Achieving a ≥ 90% Improvement in PASI Score (PASI 90) at Week 12Secondary· Baseline and week 12
The percentage of participants who achieved 90% or greater improvement from baseline in PASI score after 12 weeks of treatment. The PASI score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total
Group
Value
95% CI
Placebo
7
Etanercept
27
Number of Participants With Adverse Events During the Double-blind Treatment PeriodSecondary· 12 weeks
The severity assessment for adverse events and infections was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 0 = no toxicity, Grade 1 = mild toxicity, Grade 2 = moderate toxicity, Grade 3 = severe toxicity, Grade 4 = life-threatening toxicity.
Serious adverse events were any events that suggested a significant hazard or side effect, regardless of the investigator's or sponsor's opinion on the relationship to study medication. These included, but were not limited to, events at any dose that were fatal, life threatening, required in-patient hospitalization or prolonged h
Any adverse event
Group
Value
95% CI
Placebo
62
Etanercept
68
Escape: Etanercept
16
Non-infectious adverse event
Group
Value
95% CI
Placebo
46
Etanercept
42
Escape: Etanercept
9
Infection
Group
Value
95% CI
Placebo
33
Etanercept
50
Escape: Etanercept
9
Serious non-infectious adverse event
Group
Value
95% CI
Placebo
0
Etanercept
0
Escape: Etanercept
0
Serious infection
Group
Value
95% CI
Placebo
0
Etanercept
0
Escape: Etanercept
0
Death
Group
Value
95% CI
Placebo
0
Etanercept
0
Escape: Etanercept
0
Grade 3 non-infectious adverse event
Group
Value
95% CI
Placebo
3
Etanercept
0
Escape: Etanercept
0
Grade 3 infection
Group
Value
95% CI
Placebo
0
Etanercept
0
Escape: Etanercept
0
Etanercept Serum ConcentrationSecondary· Day 1 (predose), week 12, week 24, and week 48
Serum concentrations for etanercept were measured by using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.627 ng/mL.
Day 1
Group
Value
95% CI
Etanercept
1.50
± 3.13
Week 12
Group
Value
95% CI
Etanercept
1614
± 828
Week 24
Group
Value
95% CI
Etanercept
2104
± 1255
Week 48
Group
Value
95% CI
Etanercept
1650
± 1126
Adverse events — posted to ClinicalTrials.gov
Time frame: Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Double-blind Period: Placebo
Serious: 0/105 (0%)
Deaths: —
Double-blind Period: Etanercept 0.8 mg/kg QW
Serious: 0/106 (0%)
Deaths: —
Double-blind Period: Escape to Etanercept 0.8 mg/kg QW
Serious: 0/32 (0%)
Deaths: —
Open-label Period: Etanercept 0.8 mg/kg QW
Serious: 0/208 (0%)
Deaths: —
Open-label Period Incomplete Response: Etanercept 0.8 mg/kg QW
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 29 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00078819.