18 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 Psoriasis Area Severity Index (PASI) 90 at Week 16Primary· At Week 16
The Psoriasis Area and Severity Index (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 wi
Group
Value
95% CI
Risankizumab
62.9
53.6 – 72.1
Placebo
3.8
0.0 – 9.1
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16Primary· At Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions 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.
Group
Value
95% CI
Risankizumab
78.1
70.2 – 86.0
Placebo
9.6
1.6 – 17.6
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16Secondary· At Week 16
The Psoriasis Area and Severity Index (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
Group
Value
95% CI
Risankizumab
38.1
28.8 – 47.4
Placebo
1.9
0.0 – 5.7
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16Secondary· At Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions 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.
Group
Value
95% CI
Risankizumab
39.0
29.7 – 48.4
Placebo
1.9
0.0 – 5.7
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16Secondary· Baseline, Week 4, and Week 16
The Psoriasis Area and Severity Index (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. Negative values indicate an improvement from baseline.
Week 4
Group
Value
95% CI
Risankizumab
-50.62
-56.255 – -44.987
Placebo
-14.48
-22.490 – -6.470
Week 16
Group
Value
95% CI
Risankizumab
-89.36
-95.200 – -83.522
Placebo
-29.39
-38.152 – -20.630
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed, up to 48 weeks. In addition, serious adverse events were collected from the time the participant signed the study-specific informed consent..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
· Phase 3
· not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT07177118 — Risankizumab for Fibrostenotic Crohn's Disease Treatment
· Phase 3
· not yet recruiting
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled
· Phase 1
· completed
NCT06946524 — A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative
· Phase 1
· completed
Other recruiting trials for Psoriasis
Currently open trials in the same condition.
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· NA
· recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
· recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
· recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial
· Phase 2
· recruiting
NCT07250997 — PALLAS Laser for Skin Diseases
· NA
· recruiting
Other AbbVie trials
Trials by the same sponsor.
NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants
· Phase 1
· completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W
· Phase 3
· withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult
· Phase 1
· completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China
· completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled
· Phase 1
· completed
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: 16 March 2021
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/NCT03875482.