20 and older, 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 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)Primary· Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent
Group
Value
95% CI
Placebo (Part A)
1.7
Risankizumab 75 mg (Part A)
75.9
Risankizumab 150 mg (Part A)
74.5
Percentage of Participants Achieving PASI90 at Week 52 (Part B)Secondary· Week 52
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent
Group
Value
95% CI
Placebo/Risankizumab 75 mg (Part B)
81.5
Placebo/Risankizumab 150 mg (Part B)
85.2
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
86.2
Risankizumab150 mg /Risankizumab 150 mg (Part B)
92.7
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)Secondary· Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. Nonresponder imputation (NRI) was used for missing data.
Group
Value
95% CI
Placebo (Part A)
10.3
Risankizumab 75 mg (Part A)
86.2
Risankizumab 150 mg (Part A)
92.7
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)Secondary· Week 52
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. Nonresponder imputation (NRI) was used for missing data.
Group
Value
95% CI
Placebo/Risankizumab 75 mg (Part B)
96.3
Placebo/Risankizumab 150 mg (Part B)
88.9
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
84.5
Risankizumab150 mg /Risankizumab 150 mg (Part B)
94.5
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A)Secondary· Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent
Group
Value
95% CI
Placebo (Part A)
8.6
Risankizumab 75 mg (Part A)
89.7
Risankizumab 150 mg (Part A)
94.5
Percentage of Participants Achieving PASI75 at Week 52 (Part B)Secondary· Week 52
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent
Group
Value
95% CI
Placebo/Risankizumab 75 mg (Part B)
100
Placebo/Risankizumab 150 mg (Part B)
88.9
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
94.8
Risankizumab150 mg /Risankizumab 150 mg (Part B)
96.4
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)Secondary· Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reducti
Group
Value
95% CI
Placebo (Part A)
0
Risankizumab 75 mg (Part A)
22.4
Risankizumab 150 mg (Part A)
32.7
Percentage of Participants Achieving PASI100 at Week 52 (Part B)Secondary· Week 52
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reducti
Group
Value
95% CI
Placebo/Risankizumab 75 mg (Part B)
40.7
Placebo/Risankizumab 150 mg (Part B)
44.4
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
43.1
Risankizumab150 mg /Risankizumab 150 mg (Part B)
41.8
Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)Secondary· Week 16
Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Group
Value
95% CI
Placebo (Part A)
0
Risankizumab 75 mg (Part A)
40.0
Risankizumab 150 mg (Part A)
33.3
Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)Secondary· Week 52
Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Group
Value
95% CI
Placebo/Risankizumab 75 mg (Part B)
100
Placebo/Risankizumab 150 mg (Part B)
100
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
60.0
Risankizumab150 mg /Risankizumab 150 mg (Part B)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo (Part A)
Serious: 1/58 (2%)
Deaths: 0/58
Risankizumab 75 mg (Part A)
Serious: 2/58 (3%)
Deaths: 0/58
Risankizumab 150 mg (Part A)
Serious: 2/55 (4%)
Deaths: 0/55
Placebo/Risankizumab 75 mg (Part B)
Serious: 2/27 (7%)
Deaths: 0/27
Placebo/Risankizumab 150 mg (Part B)
Serious: 0/27 (0%)
Deaths: 0/27
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
Serious: 1/56 (2%)
Deaths: 0/56
Risankizumab 150 mg/Risankizumab 150 mg (Part B)
Serious: 1/54 (2%)
Deaths: 0/54
Serious adverse events (9 terms)
Reaction
System
Placebo (Part A)
Risankizumab 75 mg (Part A)
Risankizumab 150 mg (Part A)
Placebo/Risankizumab 75 mg…
Placebo/Risankizumab 150 m…
Risankizumab 75 mg/Risanki…
Risankizumab 150 mg/Risank…
Acute myocardial infarction
Cardiac disorders
—
—
—
—
—
—
—
Rectal polyp
Gastrointestinal disorders
—
—
—
—
—
—
—
Pneumonia bacterial
Infections and infestations
—
—
—
—
—
—
—
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05283135 — High Dose Risankizumab for Psoriasis
· Phase 2
· completed
NCT03219437 — A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Pso
· Phase 3
· completed
NCT03518047 — Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation
· Phase 3
· completed
NCT03478787 — Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
· Phase 3
· completed
NCT05283694 — A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants
· Phase 1
· completed
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Trials by the same sponsor.
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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 AbbVie
Last refreshed: 21 May 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/NCT03000075.