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

NCT05969223 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: M23-7022023-504154-35-00
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 38

Brief 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 studies by disease location, participants with moderate to severe genital psoriasis (Study-G) and moderate to severe scalp psoriasis (Study-S). In both 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.

Conditions

Genital Psoriasis; Scalp Psoriasis

Keywords

Genital Psoriasis; Scalp Psoriasis; Plaque Psoriasis; Psoriasis; ABBV066; Skyrizi; Risankizumab

Outcome Measures

Primary Outcomes (2)

• Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 at Week 16

  The sPGA-G is a 6-point score ranging from 0 to 5, with a higher score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.

  Week 16

• Study-S: Percentage of Participants With Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1 at Week 16

  The scalp IGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The scalp IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. Higher scores indicate more severe disease.

  Week 16

Secondary Outcomes (9)

• Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 at Week 16

  Week 16

• Study-G: Percentage of Participants With Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16

  Week 16

• Study-G: Percentage of Participants With Achievement of Clinically Meaningful (≥ 4-point) Improvement From Baseline on the Genital Psoriasis Itch Numerical Rating Scale (NRS) at Week 16 [Among Participants With a Baseline Score ≥ 4]

  Baseline, Week 16

• Study-G: Percentage of Participants With Achievement of Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 [Among Participants With a Baseline Score ≥ 2]

  Baseline, Week 16

• Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16

  Baseline, Week 16

Study Arms (8)

Study-G Placebo (Period A)

PLACEBO COMPARATOR

Participants with moderate to severe genital psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.

Drug: Placebo for Risankizumab

Study-G Risankizumab (Period A)

EXPERIMENTAL

Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.

Drug: Risankizumab

Study-S Placebo (Period A)

PLACEBO COMPARATOR

Participants with moderate to severe scalp psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.

Drug: Placebo for Risankizumab

Study-S Risankizumab (Period A)

EXPERIMENTAL

Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.

Drug: Risankizumab

Study-G Placebo/Risankizumab (Period B)

EXPERIMENTAL

Participants with moderate to severe genital psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.

Drug: Risankizumab

Study-G Risankizumab/Risankizumab (Period B)

EXPERIMENTAL

Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.

Drug: Risankizumab

Study-S Placebo/Risankizumab (Period B)

EXPERIMENTAL

Participants with moderate to severe scalp psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.

Drug: Risankizumab

Study-S Risankizumab/Risankizumab (Period B)

EXPERIMENTAL

Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.

Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous injection

Also known as: Skyrizi, ABBV-066

Study-G Placebo/Risankizumab (Period B); Study-G Risankizumab (Period A); Study-G Risankizumab/Risankizumab (Period B); Study-S Placebo/Risankizumab (Period B); Study-S Risankizumab (Period A); Study-S Risankizumab/Risankizumab (Period B)

Placebo for Risankizumab DRUG

Subcutaneous injection

Study-G Placebo (Period A); Study-S Placebo (Period A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have clinical diagnosis of chronic plaque psoriasis with or without psoriatic arthritis 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 moderate to severe scalp psoriasis (Study-S) defined as Psoriasis Scalp Severity Index (PSSI) \>= 12, scalp Investigator Global Assessment (IGA) \>= 3, and \>= 30% of the scalp affected.
• 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 topical treatment, phototherapy and/or systemic therapy; and be candidates for systemic therapy or phototherapy as assessed by the investigator.

You may not qualify if:

• 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 the study drug (and its excipients) and/or other products in the same class.
• Non-plaque forms of psoriasis or other active skin disease.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (38)

Medical Dermatology Specialists /ID# 262915

Phoenix, Arizona, 85006, United States

Location

Alliance Dermatology and Mohs Center /ID# 255846

Phoenix, Arizona, 85032, United States

Location

Banner University Medicine Dermatology /ID# 255845

Tucson, Arizona, 85718-1407, United States

Location

Private Practice - Dr. Tooraj Raoof /ID# 255334

Encino, California, 91436, United States

Location

Dermatology Research Associates /ID# 255347

Los Angeles, California, 90045, United States

Location

Clinical Trials Research Institute /ID# 264555

Thousand Oaks, California, 91320-2130, United States

Location

Florida Academic Dermatology Center /ID# 264065

Coral Gables, Florida, 33134-5755, United States

Location

Skin Care Research - Hollywood /ID# 255394

Hollywood, Florida, 33021-6748, United States

Location

GSI Clinical Research, LLC /ID# 255472

Margate, Florida, 33063, United States

Location

Skin and Cancer Associates, LLP /ID# 255506

Miami, Florida, 33137-3254, United States

Location

Sullivan Dermatology /ID# 264067

Miami, Florida, 33162, United States

Location

Renstar Medical Research /ID# 255339

Ocala, Florida, 34470, United States

Location

Hamilton Research, LLC /ID# 255409

Alpharetta, Georgia, 30022, United States

Location

Treasure Valley Medical Research /ID# 255671

Boise, Idaho, 83706, United States

Location

DeNova Research /ID# 264063

Chicago, Illinois, 60610, United States

Location

Arlington Dermatology /ID# 255330

Rolling Meadows, Illinois, 60008, United States

Location

The Indiana Clinical Trials Center /ID# 255333

Plainfield, Indiana, 46168, United States

Location

Dermatology Partners of Leawood /ID# 263244

Leawood, Kansas, 66211, United States

Location

DermAssociates - Rockville /ID# 263252

Rockville, Maryland, 20850, United States

Location

Skin Specialists /ID# 262929

Omaha, Nebraska, 68144, United States

Location

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

Sparks, Nevada, 89436, United States

Location

Care Access - Hoboken /ID# 264066

Hoboken, New Jersey, 07030, United States

Location

Forest Hills Dermatology Group @ Union Turnpike /ID# 255346

Kew Gardens, New York, 11415, United States

Location

Schweiger Dermatology, P.C. /ID# 255336

New York, New York, 07044-2946, United States

Location

Darst Dermatology /ID# 255848

Charlotte, North Carolina, 28277, United States

Location

Wright State Physicians Health Center /ID# 255395

Fairborn, Ohio, 45324, United States

Location

Apex Clinical Research Center /ID# 263432

Mayfield Heights, Ohio, 44124, United States

Location

Oregon Dermatology and Research Center /ID# 255670

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center /ID# 255332

Portland, Oregon, 97239, United States

Location

Studies in Dermatology LLC /ID# 262989

Cypress, Texas, 77429, United States

Location

Modern Research Associates /ID# 263234

Dallas, Texas, 75231, United States

Location

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

Houston, Texas, 77004-8097, United States

Location

U.S. Dermatology Partners Longview /ID# 266325

Longview, Texas, 75601, United States

Location

Progressive Clinical Research - San Antonio /ID# 263255

San Antonio, Texas, 78229, United States

Location

Center for Clinical Studies Webster TX /ID# 255518

Webster, Texas, 77598, United States

Location

Care Access - Danville /ID# 266300

Danville, Virginia, 24541, United States

Location

Center for Excellence in Dermatology /ID# 264647

Kennewick, Washington, 99336, United States

Location

North Sound Dermatology /ID# 264565

Mill Creek, Washington, 98012, United States

Location

Related Publications (1)

• Song EJ, Ehst B, Glick B, Lewitt GM, Rich P, Ezra N, Bagel J, Anschutz T, Bialik B, Duan C, Ashley D, Patel M, St John G, Setty AR, Ackerman L. Efficacy and Safety of Risankizumab in Genital or Scalp Psoriasis in the UnlIMMited Phase 4 Randomized Clinical Trial at Week 16. Dermatol Ther (Heidelb). 2026 Jan;16(1):293-307. doi: 10.1007/s13555-025-01544-6. Epub 2025 Oct 25.

  PMID: 41139175 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: August 10, 2023
• Primary Completion: January 22, 2025
• Study Completion: November 28, 2025
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (38)