Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Last updated: June 13, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Warts

Rash

Rosacea

Treatment

Placebo for Risankizumab

Risankizumab

Clinical Study ID

NCT04713592
M15-994
2020-000581-42
  • Ages > 18
  • All Genders

Study Summary

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms.

Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world.

Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or withoutpsoriatic arthritis) for at least 6 months before Baseline and a PalmoplantarInvestigator's Global Assessment (ppIGA) of moderate or severe, at Screening andBaseline.

  • Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA)involvement of greater than or equal to one percent, an Static Physician's GlobalAssessment (sPGA) score of moderate to severe (greater than or equal to three), aPPASI moderate to severe (greater than or equal to eight), at least one additionalPsO plaque outside of the palms and soles.

  • Must be a candidate for systemic therapy as assessed by the investigator.

  • Previously had inadequately controlled disease by topicals, phototherapy and/orsystemic treatments.

Exclusion

Exclusion Criteria:

  • History of PsO other than chronic plaque type PsO

  • History of current drug-induced PsO or a drug-induced exacerbation of pre-existingpsoriasis.

  • Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that couldinterfere with PsO assessments.

  • Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, humanimmunodeficiency virus (HIV), Active tuberculosis, Active systemicinfection/clinically important infections in the last two weeks prior to Baseline.

  • Prior exposure to risankizumab.

Study Design

Total Participants: 174
Treatment Group(s): 2
Primary Treatment: Placebo for Risankizumab
Phase: 3
Study Start date:
February 26, 2021
Estimated Completion Date:
April 20, 2023

Connect with a study center

  • Beacon Dermatology Inc /ID# 220940

    Calgary, Alberta T3E 0B2
    Canada

    Site Not Available

  • Dr. Chih-ho Hong Medical Inc. /ID# 220941

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Dr. Irina Turchin PC Inc. /ID# 220938

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • NewLab Clinical Research Inc. /ID# 220934

    St. John's, Newfoundland and Labrador A1C 2H5
    Canada

    Site Not Available

  • Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Research Toronto /ID# 220939

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

  • Innovaderm Research Inc. /ID# 222126

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Centre de recheche dermatologique du Quebec Metropolitain /ID# 220935

    Quebec City, Quebec G1V 4X7
    Canada

    Site Not Available

  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935

    Québec, Quebec G1V 4X7
    Canada

    Site Not Available

  • Centre de recheche dermatologique du Quebec Metropolitain /ID# 220935

    Québec, Quebec G1V 4X7
    Canada

    Site Not Available

  • Dr. Samuel Sanchez PSC /ID# 218789

    Caguas, 00727
    Puerto Rico

    Site Not Available

  • Alma M. Cruz Santana, MD-Private practice /ID# 218790

    Carolina, 00985
    Puerto Rico

    Site Not Available

  • Cruz-Santana, Carolina, PR /ID# 218790

    Carolina, 00985
    Puerto Rico

    Site Not Available

  • Pan American Center for Oncology Trials, LLC /ID# 218788

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Clinical Research Puerto Rico /ID# 218787

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • GCM Medical Group, PSC /ID# 218786

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Hospital Regional de Malaga /ID# 220900

    Málaga, Malaga 29010
    Spain

    Site Not Available

  • Hospital Universitario Basurto /ID# 220904

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal /ID# 220908

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario de la Princesa /ID# 224911

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga /ID# 220900

    Malaga, 29011
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio /ID# 220907

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia /ID# 220898

    Valencia, 46014
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe /ID# 220903

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Clinico Universitario Lozano Blesa /ID# 222492

    Zaragoza, 50009
    Spain

    Site Not Available

  • Advanced Research Associates - Glendale /ID# 219197

    Glendale, Arizona 85308
    United States

    Site Not Available

  • Burke Pharmaceutical Research /ID# 223349

    Hot Springs, Arkansas 71913-6404
    United States

    Site Not Available

  • NW Arkansas Clinical Trials Center /ID# 231602

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Dermatology Research Associates /ID# 219195

    Los Angeles, California 90045
    United States

    Site Not Available

  • Integrative Skin Science and Research /ID# 219216

    Sacramento, California 95815
    United States

    Site Not Available

  • Medderm Associates /ID# 219210

    San Diego, California 92103
    United States

    Site Not Available

  • Colorado Center for Dermatology, PLLC /ID# 219223

    Centennial, Colorado 80111-1724
    United States

    Site Not Available

  • Skin Care Research - Boca Raton /ID# 219184

    Boca Raton, Florida 33486-2269
    United States

    Site Not Available

  • Skin Care Research - Hollywood /ID# 219184

    Hollywood, Florida 33021-6748
    United States

    Site Not Available

  • GSI Clinical Research, LLC /ID# 219175

    Margate, Florida 33063
    United States

    Site Not Available

  • Savin Medical Group, LLC /ID# 227754

    Miami Lakes, Florida 33014-2490
    United States

    Site Not Available

  • Lenus Research & Medical Group /ID# 219202

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Hamilton Research, LLC /ID# 219224

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Northshore University Health System-Evanston /ID# 219220

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Arlington Dermatology /ID# 219211

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Dawes Fretzin, LLC /ID# 219219

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • The Dermatology Center PSC - New Albany /ID# 219183

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Epiphany Dermatology of Kansas LLC /ID# 219208

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Skin Sciences, PLLC /ID# 219204

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Allcutis Research LLC /ID# 222272

    Methuen, Massachusetts 01844-5864
    United States

    Site Not Available

  • David Fivenson, MD, PLC /ID# 219180

    Ann Arbor, Michigan 48103
    United States

    Site Not Available

  • Henry Ford Medical Center /ID# 219205

    Detroit, Michigan 48202-3046
    United States

    Site Not Available

  • Advanced Dermatology of the Midlands /ID# 219207

    Omaha, Nebraska 68144-1105
    United States

    Site Not Available

  • Psoriasis Treatment Center of Central New Jersey /ID# 219201

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Forest Hills Dermatology Group /ID# 219200

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai /ID# 219206

    New York, New York 10029-6504
    United States

    Site Not Available

  • ClinOhio Research Services /ID# 222298

    Columbus, Ohio 43213-4440
    United States

    Site Not Available

  • University of Pittsburgh MC /ID# 219203

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • Velocity Clinical Research-Providence /ID# 223350

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Velocity Clinical Research-Providence /ID# 223350

    Warwick, Rhode Island 02886-1617
    United States

    Site Not Available

  • Palmetto Clinical Trial Services /ID# 222275

    Fountain Inn, South Carolina 29644-1928
    United States

    Site Not Available

  • Palmetto Clinical Trial Services /ID# 222299

    Fountain Inn, South Carolina 29644-1928
    United States

    Site Not Available

  • International Clinical Research - Tennessee LLC /ID# 220930

    Murfreesboro, Tennessee 37130-2450
    United States

    Site Not Available

  • Menter Dermatology Res Inst /ID# 219161

    Dallas, Texas 75246
    United States

    Site Not Available

  • Center for Clinical Studies - Houston (Binz) /ID# 219221

    Houston, Texas 77004-8097
    United States

    Site Not Available

  • Advanced Clinical Research - Woseth Dermatology /ID# 224750

    Salt Lake City, Utah 84117-4209
    United States

    Site Not Available

  • The Education & Research Foundation, Inc. /ID# 221764

    Lynchburg, Virginia 24501-1403
    United States

    Site Not Available

  • Virginia Clinical Research, Inc. /ID# 219181

    Norfolk, Virginia 23507
    United States

    Site Not Available

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