Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis

Last updated: February 24, 2025
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

4

Condition

Rash

Rosacea

Scalp Disorders

Treatment

Placebo for Risankizumab

Risankizumab

Clinical Study ID

NCT05969223
M23-702
2023-504154-35-00
  • Ages > 18
  • All Genders

Study Summary

Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored.

Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally.

The study will be broken up into 2 sub-studies by disease location, participants with moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study S). In both sub-studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.

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:

  • Must have clinical diagnosis of chronic plaque psoriasis with or without psoriaticarthritis for at least 6 months before the baseline visit.

  • Must have a current diagnosis of moderate to severe genital psoriasis (Study-G)defined as static Physician Global Assessment of Genitalia (sPGA-G) ≥ 3 or moderateto severe scalp psoriasis (Study-S) defined as Psoriasis Scalp Severity Index (PSSI) >= 12, scalp Investigator Global Assessment (IGA) >= 3, and >= 30% of the scalpaffected.

  • Must have body surface area (BSA) ≥ 1% with at least 60% of subjects having BSA ≥ 10%; sPGA ≥ 3; inadequate control of psoriasis and/or intolerance to topicaltreatment, phototherapy and/or systemic therapy; and be candidates for systemictherapy or phototherapy as assessed by the investigator.

Exclusion

Exclusion Criteria:

  • Had previous exposure to IL-23 inhibitors including but not limited to guselkumab,tildrakizumab, ustekinumab, mirikizumab, or risankizumab.

  • History of an allergic reaction or significant sensitivity to constituents of thestudy drug (and its excipients) and/or other products in the same class.

  • Non-plaque forms of psoriasis or other active skin disease.

Study Design

Total Participants: 214
Treatment Group(s): 2
Primary Treatment: Placebo for Risankizumab
Phase: 4
Study Start date:
August 10, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Alliance Dermatology and MOHs Center, PC /ID# 255846

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Alliance Dermatology and Mohs Center /ID# 255846

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Medical Dermatology Specialists /ID# 262915

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Banner University Medicine Dermatology /ID# 255845

    Tucson, Arizona 85718-1407
    United States

    Site Not Available

  • Joseph Raoof Md,Inc /Id# 255334

    Encino, California 91436
    United States

    Site Not Available

  • Private Practice - Dr. Joseph Raoof /ID# 255334

    Encino, California 91436
    United States

    Active - Recruiting

  • T. Joseph Raoof Md,Inc /Id# 255334

    Encino, California 91436
    United States

    Active - Recruiting

  • Dermatology Research Associates /ID# 255347

    Los Angeles, California 90045
    United States

    Site Not Available

  • Clinical Trials Research Institute /ID# 264555

    Thousand Oaks, California 91320-2130
    United States

    Site Not Available

  • Florida Academic Dermatology Center /ID# 264065

    Coral Gables, Florida 33134-5755
    United States

    Site Not Available

  • Skin Care Research - Hollywood /ID# 255394

    Hollywood, Florida 33021-6748
    United States

    Site Not Available

  • GSI Clinical Research, LLC /ID# 255472

    Margate, Florida 33063
    United States

    Site Not Available

  • Skin and Cancer Associates, LLP /ID# 255506

    Miami, Florida 33137-3254
    United States

    Site Not Available

  • Ziaderm Research LLC /ID# 264067

    Miami, Florida 33162
    United States

    Site Not Available

  • Renstar Medical Research /ID# 255339

    Ocala, Florida 34470
    United States

    Site Not Available

  • Hamilton Research, LLC /ID# 255409

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Treasure Valley Medical Research /ID# 255671

    Boise, Idaho 83706
    United States

    Site Not Available

  • DeNova Research /ID# 264063

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Arlington Dermatology /ID# 255330

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • The Indiana Clinical Trials Center /ID# 255333

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Dermatology Partners of Leawood /ID# 263244

    Leawood, Kansas 66211
    United States

    Site Not Available

  • DermAssociates - Rockville /ID# 263252

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Skin Specialists /ID# 262929

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute (SCDI) /ID# 264570

    Sparks, Nevada 89436
    United States

    Site Not Available

  • Psoriasis Treatment Center of Central New Jersey /ID# 255336

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Care Access - Hoboken /ID# 264066

    Hoboken, New Jersey 07030
    United States

    Site Not Available

  • Forest Hills Dermatology Group /ID# 255346

    Kew Gardens, New York 11415
    United States

    Active - Recruiting

  • Forest Hills Dermatology Group @ Union Turnpike /ID# 255346

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Schweiger Dermatology, P.C. /ID# 255336

    New York, New York 07044-2946
    United States

    Site Not Available

  • Schweiger Dermatology, P.C. /ID# 255336

    Verona, New York 07044-2946
    United States

    Site Not Available

  • Darst Dermatology /ID# 255848

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Wright State Physicians - Fairborn /ID# 255395

    Fairborn, Ohio 45324-2640
    United States

    Site Not Available

  • Wright State Physicians Health Center /ID# 255395

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Wright State Physicians, Inc /ID# 255395

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

  • Apex Clinical Research Center /ID# 263432

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Apex Dermatology & Skin Surgery Center /ID# 263432

    Mayfield Heights, Ohio 44124-4005
    United States

    Active - Recruiting

  • Oregon Dermatology and Research Center /ID# 255670

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Health & Science University /ID# 255332

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Oregon Medical Research Center /ID# 255332

    Portland, Oregon 97239
    United States

    Site Not Available

  • Studies in Dermatology LLC /ID# 262989

    Cypress, Texas 77429
    United States

    Site Not Available

  • Modern Research Associates /ID# 263234

    Dallas, Texas 75231
    United States

    Site Not Available

  • Center for Clinical Studies - Houston (Binz) /ID# 255396

    Houston, Texas 77004-8097
    United States

    Site Not Available

  • Center for Clinical Studies - Houston (Binz) /ID# 255518

    Houston, Texas 77004-8097
    United States

    Active - Recruiting

  • U.S. Dermatology Partners Longview /ID# 266325

    Longview, Texas 75601
    United States

    Site Not Available

  • US Dermatology Partners Longview /ID# 266325

    Longview, Texas 75601
    United States

    Active - Recruiting

  • Progressive Clinical Research - San Antonio /ID# 263255

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Center for Clinical Studies - Webster TX /ID# 255518

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Center for Clinical Studies Webster TX /ID# 255518

    Webster, Texas 77598
    United States

    Site Not Available

  • Center for Clinical Studies, LTD. LLP /ID# 255396

    Webster, Texas 77598
    United States

    Site Not Available

  • Center for Clinical Studies, LTD. LLP /ID# 255518

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Care Access - Danville /ID# 266300

    Danville, Virginia 24541
    United States

    Site Not Available

  • Care Access, Danville /ID# 266300

    Danville, Virginia 24541
    United States

    Active - Recruiting

  • Center for Excellence in Dermatology /ID# 264647

    Kennewick, Washington 99336
    United States

    Site Not Available

  • North Sound Dermatology /ID# 264565

    Mill Creek, Washington 98012
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.