A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03875482

Run by

AbbVie

People needed

157

Starts

2019-05-13

Expected to finish

2020-07-15

Last updated by the study team

2021-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
• Participant meets following disease activity criteria:
• Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
• Candidate for systemic therapy as assessed by the investigator.

You may not qualify if…

• Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
• Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
• Participant has previous exposure to risankizumab.

Where it is running

• Total Skin and Beauty Derm Ctr /ID# 210366 — Birmingham, Alabama, United States
• Alliance Dermatology and MOHs /ID# 210645 — Phoenix, Arizona, United States
• Hull Dermatology, PA /ID# 210305 — Rogers, Arkansas, United States
• Anaheim Clinical Trials LLC /ID# 212559 — Anaheim, California, United States
• Wallace Medical Group, Inc. /ID# 210403 — Beverly Hills, California, United States
• Dermatology Res. Assoc., CA /ID# 210402 — Los Angeles, California, United States
• Integrative Skin Science and Research /ID# 212551 — Sacramento, California, United States
• Mosaic Dermatology /ID# 210780 — Santa Monica, California, United States
• Skin Care Research, LLC /ID# 210514 — Boca Raton, Florida, United States
• ACCEL Research Sites /ID# 212709 — DeLand, Florida, United States
• Multi-Speciality Research Associates /ID# 211625 — Lake City, Florida, United States
• GSI Clinical Research, LLC /ID# 210330 — Margate, Florida, United States
• Suncoast Clinical Research /ID# 210874 — New Port Richey, Florida, United States
• Ormond Medical Arts Pharmaceutical Research Center /ID# 212781 — Ormond Beach, Florida, United States
• Progressive Medical Research /ID# 210877 — Port Orange, Florida, United States
• Precision Clinical Research /ID# 212921 — Sunrise, Florida, United States
• Lenus Research & Medical Group /ID# 212584 — Sweetwater, Florida, United States
• Treasure Valley Dermatology /ID# 212707 — Boise, Idaho, United States
• Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562 — Normal, Illinois, United States
• The Indiana Clinical Trials Center /ID# 210205 — Plainfield, Indiana, United States
• Forefront Dermatology /ID# 210520 — Louisville, Kentucky, United States
• DS Research /ID# 210272 — Louisville, Kentucky, United States
• David Fivenson, MD, PLC /ID# 210193 — Ann Arbor, Michigan, United States
• Clarkston Skin Research /ID# 210197 — Clarkston, Michigan, United States
• Henry Ford Medical Center /ID# 211598 — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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