Clinical trial NCT03875482: A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Risankizumab
Psoriasis
Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
timeFrame: At Week 16
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
timeFrame: At Week 16
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16
timeFrame: At Week 16
Other outcomes:
measure: Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16
timeFrame: Baseline, Week 4, and Week 16
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Derm Ctr /ID# 210366
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHs /ID# 210645
state: Arizona
city: Rogers
country: United States
facility: Hull Dermatology, PA /ID# 210305
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 212559
state: California
city: Beverly Hills
country: United States
facility: Wallace Medical Group, Inc. /ID# 210403
state: California
city: Los Angeles
country: United States
facility: Dermatology Res. Assoc., CA /ID# 210402
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 212551
state: California
city: Santa Monica
country: United States
facility: Mosaic Dermatology /ID# 210780
state: California
city: Boca Raton
country: United States
facility: Skin Care Research, LLC /ID# 210514
state: Florida
city: DeLand
country: United States
facility: ACCEL Research Sites /ID# 212709
state: Florida
city: Lake City
country: United States
facility: Multi-Speciality Research Associates /ID# 211625
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC /ID# 210330
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research /ID# 210874
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center /ID# 212781
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research /ID# 210877
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research /ID# 212921
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group /ID# 212584
state: Florida
city: Boise
country: United States
facility: Treasure Valley Dermatology /ID# 212707
state: Idaho
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center /ID# 210205
state: Indiana
city: Louisville
country: United States
facility: Forefront Dermatology /ID# 210520
state: Kentucky
city: Louisville
country: United States
facility: DS Research /ID# 210272
state: Kentucky
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC /ID# 210193
state: Michigan
city: Clarkston
country: United States
facility: Clarkston Skin Research /ID# 210197
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center /ID# 211598
state: Michigan
city: Kirksville
country: United States
facility: Cleaver Dermatology /ID# 210300
state: Missouri
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands /ID# 212763
state: Nebraska
city: Omaha
country: United States
facility: Skin Specialists, PC /ID# 211490
state: Nebraska
city: East Windsor
country: United States
facility: Psoriasis Treatment Ctr NJ /ID# 210837
state: New Jersey
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of NY and NJ /ID# 210208
state: New Jersey
city: Stony Brook
country: United States
facility: DermResearchCenter of NY, Inc. /ID# 210652
state: New York
city: Wilmington
country: United States
facility: WDC Cosmetic and Research, PLLC /ID# 210372
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute (LHSI) /ID# 213216
state: Oklahoma
city: Johnston
country: United States
facility: Clinical Partners, LLC /ID# 210642
state: Rhode Island
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services /ID# 210368
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Ctr /ID# 213069
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 210344
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 210361
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research /ID# 210359
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology /ID# 212252
state: Texas
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez, PSC /ID# 211142
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC /ID# 212445
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 211144
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5.