A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

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

Phase

3

Condition

Rash

Warts

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT03875482
M15-999
  • Ages > 18
  • All Genders

Study 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.

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 greater than or equalto 10% body surface area (BSA) psoriasis involvement, static physician globalassessment (sPGA) score of greater than or equal to 3, and Psoriasis Area SeverityIndex (PASI) greater than or equal to 12 at Screening and baseline visit.
  • 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: 157
Study Start date:
May 13, 2019
Estimated Completion Date:
July 15, 2020

Study 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.

Connect with a study center

  • Dr. Samuel Sanchez, PSC /ID# 211142

    Caguas, 00727
    Puerto Rico

    Site Not Available

  • Pan American Center for Oncology Trials, LLC /ID# 212445

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Clinical Research Puerto Rico /ID# 211144

    San Juan, 0090
    Puerto Rico

    Site Not Available

  • Total Skin and Beauty Derm Ctr /ID# 210366

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Alliance Dermatology and MOHs /ID# 210645

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Hull Dermatology, PA /ID# 210305

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Anaheim Clinical Trials LLC /ID# 212559

    Anaheim, California 92801-2658
    United States

    Site Not Available

  • Wallace Medical Group, Inc. /ID# 210403

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Dermatology Res. Assoc., CA /ID# 210402

    Los Angeles, California 90045
    United States

    Site Not Available

  • Integrative Skin Science and Research /ID# 212551

    Sacramento, California 95815-4500
    United States

    Site Not Available

  • Medderm Associates /ID# 210401

    San Diego, California 92103
    United States

    Site Not Available

  • Mosaic Dermatology /ID# 210780

    Santa Monica, California 90404
    United States

    Site Not Available

  • Skin Care Research, LLC /ID# 210514

    Boca Raton, Florida 33486-2269
    United States

    Site Not Available

  • ACCEL Research Sites /ID# 212709

    DeLand, Florida 32720
    United States

    Site Not Available

  • Hollywood Dermatology /ID# 210514

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Multi-Speciality Research Associates /ID# 211625

    Lake City, Florida 32055-8835
    United States

    Site Not Available

  • GSI Clinical Research, LLC /ID# 210330

    Margate, Florida 33063
    United States

    Site Not Available

  • Suncoast Clinical Research /ID# 210874

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Ormond Medical Arts Pharmaceutical Research Center /ID# 212781

    Ormond Beach, Florida 32174-6302
    United States

    Site Not Available

  • Progressive Medical Research /ID# 210877

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Precision Clinical Research /ID# 212921

    Sunrise, Florida 33351-7311
    United States

    Site Not Available

  • Lenus Research & Medical Group /ID# 212584

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Treasure Valley Dermatology /ID# 212707

    Boise, Idaho 83713-0997
    United States

    Site Not Available

  • Northshore University Health System-Evanston /ID# 210381

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562

    Normal, Illinois 61761
    United States

    Site Not Available

  • NorthShore University HealthSystem - Skokie /ID# 210381

    Skokie, Illinois 60077
    United States

    Site Not Available

  • The Indiana Clinical Trials Center /ID# 210205

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • DS Research /ID# 210272

    Louisville, Kentucky 40241-6162
    United States

    Site Not Available

  • Forefront Dermatology /ID# 210520

    Louisville, Kentucky 40202-2862
    United States

    Site Not Available

  • David Fivenson, MD, PLC /ID# 210193

    Ann Arbor, Michigan 48103
    United States

    Site Not Available

  • Clarkston Skin Research /ID# 210197

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Henry Ford Medical Center /ID# 211598

    Detroit, Michigan 48202-3046
    United States

    Site Not Available

  • Cleaver Dermatology /ID# 210300

    Kirksville, Missouri 63501-5362
    United States

    Site Not Available

  • Advanced Dermatology of the Midlands /ID# 212763

    Omaha, Nebraska 68144-1105
    United States

    Site Not Available

  • Skin Specialists, PC /ID# 211490

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Darmouth-Hitchcock Medical Cen /ID# 210644

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Psoriasis Treatment Ctr NJ /ID# 210837

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Skin Laser and Surgery Specialists of NY and NJ /ID# 210208

    Hackensack, New Jersey 07601-1997
    United States

    Site Not Available

  • DermResearchCenter of NY, Inc. /ID# 210652

    Stony Brook, New York 11790
    United States

    Site Not Available

  • WDC Cosmetic and Research, PLLC /ID# 210372

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Lynn Health Science Institute (LHSI) /ID# 213216

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Oregon Health and Science University (OHSU) /ID# 210336

    Portland, Oregon 97239-4501
    United States

    Site Not Available

  • Clinical Partners, LLC /ID# 210642

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Palmetto Clinical Trial Services /ID# 210368

    Fountain Inn, South Carolina 29644-1928
    United States

    Site Not Available

  • Coastal Carolina Research Ctr /ID# 213069

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Arlington Research Center, Inc /ID# 210344

    Arlington, Texas 76011
    United States

    Site Not Available

  • Center for Clinical Studies - Houston (Binz) /ID# 210361

    Houston, Texas 77004-8097
    United States

    Site Not Available

  • Progressive Clinical Research /ID# 210359

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Acclaim Dermatology /ID# 212252

    Sugar Land, Texas 77479-2645
    United States

    Site Not Available

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