A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

Completed · Phase 3

Conditions studied: Psoriasis

In brief

The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.

Key facts

Study ID

NCT03875508

Run by

AbbVie

People needed

108

Starts

2019-06-04

Expected to finish

2020-08-25

Last updated by the study team

2021-05-11

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 ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 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

• Advanced Research Associates /ID# 210634 — Glendale, Arizona, United States
• Cognitive Clinical Trials /ID# 210770 — Scottsdale, Arizona, United States
• Burke Pharmaceutical Research /ID# 211386 — Hot Springs, Arkansas, United States
• Bakersfield Derma & Skin Cance /ID# 210773 — Bakersfield, California, United States
• Encino Research Center / T. Jo /ID# 211735 — Encino, California, United States
• Tien Q Nguyen MD, Inc /ID# 210775 — Fountain Valley, California, United States
• UC Davis Health /ID# 210411 — Sacramento, California, United States
• Dermatology Physicians of CT /ID# 210637 — Shelton, Connecticut, United States
• Florida Academic Centers Research /ID# 210337 — Coral Gables, Florida, United States
• Medallion Clinical Research Institute, LLC /ID# 210329 — Naples, Florida, United States
• Renstar Medical Research /ID# 210878 — Ocala, Florida, United States
• Epiphany Dermatology /ID# 211493 — Overland Park, Kansas, United States
• DermAssociates /ID# 210838 — Rockville, Maryland, United States
• Great Lakes Research, Inc. /ID# 210192 — Bay City, Michigan, United States
• Somerset Skin Centre /ID# 211596 — Troy, Michigan, United States
• Central Dermatology, PC /ID# 210301 — St Louis, Missouri, United States
• AllCutis Research Inc /ID# 211429 — Portsmouth, New Hampshire, United States
• Medication Management, LLC /ID# 213217 — Greensboro, North Carolina, United States
• Oregon Medical Res Center PC /ID# 210334 — Portland, Oregon, United States
• University of Pittsburgh MC /ID# 210839 — Pittsburgh, Pennsylvania, United States
• Center for Clinical Studies /ID# 211565 — Cypress, Texas, United States
• Center for Clinical Studies /ID# 210362 — Houston, Texas, United States
• Suzanne Bruce and Associates /ID# 212210 — Houston, Texas, United States
• Austin Institute for Clinical Research /ID# 212203 — Pflugerville, Texas, United States
• Premier Clinical Research /ID# 212209 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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