Clinical trial NCT03875508: A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Official title: Plaque Psoriasis: Usability of the Risankizumab Autoinjector Combination Product in Adults With Moderate to Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Risankizumab
Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 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 ≥ 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

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 With an Observer Rating of Successful Participant Self-administration
timeFrame: Day 1 and Week 28
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
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
timeFrame: At Week 16
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16
timeFrame: At Week 16
measure: Percentage of Participants Who Had No Potential Hazards as Measured by an Observer
timeFrame: Day 1 and Week 28
measure: Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)
timeFrame: Day 1, Week 4, Week 16, Week 28
Secondary outcomes:
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: Glendale
country: United States
facility: Advanced Research Associates /ID# 210634
state: Arizona
city: Scottsdale
country: United States
facility: Cognitive Clinical Trials /ID# 210770
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research /ID# 211386
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Derma & Skin Cance /ID# 210773
state: California
city: Encino
country: United States
facility: Encino Research Center / T. Jo /ID# 211735
state: California
city: Fountain Valley
country: United States
facility: Tien Q Nguyen MD, Inc /ID# 210775
state: California
city: Sacramento
country: United States
facility: UC Davis Health /ID# 210411
state: California
city: Shelton
country: United States
facility: Dermatology Physicians of CT /ID# 210637
state: Connecticut
city: Coral Gables
country: United States
facility: Florida Academic Centers Research /ID# 210337
state: Florida
city: Naples
country: United States
facility: Medallion Clinical Research Institute, LLC /ID# 210329
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research /ID# 210878
state: Florida
city: Overland Park
country: United States
facility: Epiphany Dermatology /ID# 211493
state: Kansas
city: Rockville
country: United States
facility: DermAssociates /ID# 210838
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research, Inc. /ID# 210192
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre /ID# 211596
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology, PC /ID# 210301
state: Missouri
city: Portsmouth
country: United States
facility: AllCutis Research Inc /ID# 211429
state: New Hampshire
city: Greensboro
country: United States
facility: Medication Management, LLC /ID# 213217
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Res Center PC /ID# 210334
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 210839
state: Pennsylvania
city: Cypress
country: United States
facility: Center for Clinical Studies /ID# 211565
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies /ID# 210362
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates /ID# 212210
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research /ID# 212203
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 212209
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Mem Lutheran Hosp /ID# 210194
state: Wisconsin
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: