A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT04102007
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Risankizumab — DRUG
    Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).

Study Details

This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.

Key Dates

Start date
Nov 12, 2019
Status verified
Nov 2023
Primary completion
Jan 17, 2022
Completion
Nov 7, 2022

Study Design

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

Arms

  • Other: Risankizumab
    Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab

Primary Outcome Measure

Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 [ Time Frame: At Week 16 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Alliance Dermatology and MOHs /ID# 216001PhoenixArizona85032-
Burke Pharmaceutical Research /ID# 225023Hot SpringsArkansas71913-6404-
Arkansas Research Trials /ID# 225497North Little RockArkansas72117-
Bakersfield Derma & Skin Cance /ID# 213480BakersfieldCalifornia93309-
UC Davis Health /ID# 225367SacramentoCalifornia95816-3300-
CCD Research, PLLC /ID# 216062CromwellConnecticut06416-1745-
Florida International Rsrch cr /ID# 224983MiamiFlorida33173-
Advanced Medical Research /ID# 213484Sandy SpringsGeorgia30328-6141-
Arlington Dermatology /ID# 216000Rolling MeadowsIllinois60008-
Dawes Fretzin, LLC /ID# 216004IndianapolisIndiana46256-
DermAssociates-Rockville /ID# 213837RockvilleMaryland20850-
Cleaver Dermatology /ID# 226137KirksvilleMissouri63501-5362-
Central Dermatology, PC /ID# 213479St LouisMissouri63117-
University Hospitals Case Medical Center /ID# 214795ClevelandOhio44106-
University of Pittsburgh MC /ID# 225644PittsburghPennsylvania15260-
Clinical Partners, LLC /ID# 213836JohnstonRhode Island02919-
Arlington Research Center, Inc /ID# 215526ArlingtonTexas76011-
Bellaire Dermatology /ID# 225486BellaireTexas77401-
Menter Dermatology Res Inst /ID# 214002DallasTexas75246-
Modern Research Associates, PL /ID# 213835DallasTexas75231-

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