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

Last updated: April 19, 2021
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Rash

Warts

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT03875508
M16-005
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has diagnosis of chronic plaque psoriasis for at least 6 months before thebaseline visit
  • Participant meets following disease activity criteria:
  • Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surfacearea (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baselinevisit
  • Candidate for systemic therapy as assessed by the investigator

Exclusion

Exclusion Criteria:

  • Participant has history of active skin disease other than psoriasis that couldinterfere with the assessment of psoriasis
  • Participant has history of erythrodermic psoriasis, generalized or localized pustularpsoriasis, medication-induced or medication-exacerbated psoriasis, or new onsetguttate psoriasis
  • Participant has previous exposure to risankizumab

Study Design

Total Participants: 108
Study Start date:
June 04, 2019
Estimated Completion Date:
August 25, 2020

Study 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.

Connect with a study center

  • UAB Department of Dermatology /ID# 210384

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Advanced Research Associates /ID# 210634

    Glendale, Arizona 85308
    United States

    Site Not Available

  • Cognitive Clinical Trials /ID# 210770

    Scottsdale, Arizona 85258-4446
    United States

    Site Not Available

  • Burke Pharmaceutical Research /ID# 211386

    Hot Springs, Arkansas 71913-6404
    United States

    Site Not Available

  • Bakersfield Derma & Skin Cance /ID# 210773

    Bakersfield, California 93309
    United States

    Site Not Available

  • Encino Research Center / T. Jo /ID# 211735

    Encino, California 91436
    United States

    Site Not Available

  • Tien Q Nguyen MD, Inc /ID# 210775

    Fountain Valley, California 92708-3701
    United States

    Site Not Available

  • Center for Dermatology Clin Res /ID# 210319

    Fremont, California 94538
    United States

    Site Not Available

  • University of California Irvine /ID# 210776

    Irvine, California 92697-1385
    United States

    Site Not Available

  • UC Davis Health /ID# 210411

    Sacramento, California 95816
    United States

    Site Not Available

  • Dermatology Physicians of CT /ID# 210637

    Shelton, Connecticut 06484-6211
    United States

    Site Not Available

  • Howard University Hospital /ID# 212843

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Florida Academic Centers Research /ID# 210337

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Medallion Clinical Research Institute, LLC /ID# 210329

    Naples, Florida 34102
    United States

    Site Not Available

  • Sullivan Dermatology /ID# 210338

    North Miami Beach, Florida 33162-4708
    United States

    Site Not Available

  • Renstar Medical Research /ID# 210878

    Ocala, Florida 34470
    United States

    Site Not Available

  • Park Avenue Dermatology, PA /ID# 210880

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Epiphany Dermatology /ID# 211493

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • DermAssociates /ID# 210838

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Tufts Medical Center /ID# 210640

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Great Lakes Research, Inc. /ID# 210192

    Bay City, Michigan 48602
    United States

    Site Not Available

  • Somerset Skin Centre /ID# 211596

    Troy, Michigan 48084
    United States

    Site Not Available

  • Central Dermatology, PC /ID# 210301

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • JDR Dermatology Research, LLC /ID# 210774

    Las Vegas, Nevada 89148-2419
    United States

    Site Not Available

  • Northeast Dermatology Associates /ID# 211429

    Dover, New Hampshire 03820-2454
    United States

    Site Not Available

  • AllCutis Research Inc /ID# 211429

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Medication Management, LLC /ID# 213217

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Rapid Medical Research, INC /ID# 210207

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Oregon Medical Res Center PC /ID# 210334

    Portland, Oregon 97223
    United States

    Site Not Available

  • Temple /ID# 210772

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • University of Pittsburgh MC /ID# 210839

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • Rhode Island Hospital /ID# 210639

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Center for Clinical Studies /ID# 211565

    Cypress, Texas 77433
    United States

    Site Not Available

  • Center for Clinical Studies /ID# 210362

    Houston, Texas 77004
    United States

    Site Not Available

  • Suzanne Bruce and Associates /ID# 212210

    Houston, Texas 77056
    United States

    Site Not Available

  • Austin Institute for Clinical Research /ID# 212203

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Premier Clinical Research /ID# 212209

    Spokane, Washington 99202
    United States

    Site Not Available

  • Mercyhealth East /ID# 212610

    Janesville, Wisconsin 53546-1626
    United States

    Site Not Available

  • Froedtert Mem Lutheran Hosp /ID# 210194

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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