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

Part of paid clinical trials in Glendale, Arizona.

Sponsor
AbbVie
Study ID
NCT03875508
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Risankizumab — DRUG
    Risankizumab to be injected subcutaneously (SC)
  • Autoinjector — DEVICE
    Single dose pre-filled autoinjector containing risankizumab for SC injection

Study Details

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 Dates

Start date
Jun 4, 2019
Status verified
Apr 2021
Primary completion
Apr 24, 2020
Completion
Aug 25, 2020

Study Design

Enrollment
108 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Risankizumab
    Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28

Primary Outcome Measure

Percentage of Participants With an Observer Rating of Successful Participant Self-administration [ Time Frame: Day 1 and Week 28 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Advanced Research Associates /ID# 210634GlendaleArizona85308-
Cognitive Clinical Trials /ID# 210770ScottsdaleArizona85258-4446-
Burke Pharmaceutical Research /ID# 211386Hot SpringsArkansas71913-6404-
Bakersfield Derma & Skin Cance /ID# 210773BakersfieldCalifornia93309-
Encino Research Center / T. Jo /ID# 211735EncinoCalifornia91436-
Tien Q Nguyen MD, Inc /ID# 210775Fountain ValleyCalifornia92708-3701-
UC Davis Health /ID# 210411SacramentoCalifornia95816-
Dermatology Physicians of CT /ID# 210637SheltonConnecticut06484-6211-
Florida Academic Centers Research /ID# 210337Coral GablesFlorida33134-
Medallion Clinical Research Institute, LLC /ID# 210329NaplesFlorida34102-
Renstar Medical Research /ID# 210878OcalaFlorida34470-
Epiphany Dermatology /ID# 211493Overland ParkKansas66215-
DermAssociates /ID# 210838RockvilleMaryland20850-
Great Lakes Research, Inc. /ID# 210192Bay CityMichigan48602-
Somerset Skin Centre /ID# 211596TroyMichigan48084-
Central Dermatology, PC /ID# 210301St LouisMissouri63117-
AllCutis Research Inc /ID# 211429PortsmouthNew Hampshire03801-
Medication Management, LLC /ID# 213217GreensboroNorth Carolina27408-
Oregon Medical Res Center PC /ID# 210334PortlandOregon97223-
University of Pittsburgh MC /ID# 210839PittsburghPennsylvania15260-
Center for Clinical Studies /ID# 211565CypressTexas77433-
Center for Clinical Studies /ID# 210362HoustonTexas77004-
Suzanne Bruce and Associates /ID# 212210HoustonTexas77056-
Austin Institute for Clinical Research /ID# 212203PflugervilleTexas78660-
Premier Clinical Research /ID# 212209SpokaneWashington99202-
Froedtert Mem Lutheran Hosp /ID# 210194MilwaukeeWisconsin53226-

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