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

A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for the Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Scalp Psoriasis; Genital Psoriasis
• Intervention / Treatment: Drug: Risankizumab; Drug: Placebo for Risankizumab

Detailed Description

Safety and efficacy data through 22 January 2025 are included in the interim analysis, which was conducted after all participants completed Week 16 of Study-G or Study-S in Period A.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists /ID# 262915
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and Mohs Center /ID# 255846
    • Tucson, Arizona, United States, 85718-1407
      • Banner University Medicine Dermatology /ID# 255845
  • California
    • Encino, California, United States, 91436
      • Private Practice - Dr. Tooraj Raoof /ID# 255334
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates /ID# 255347
    • Thousand Oaks, California, United States, 91320-2130
      • Clinical Trials Research Institute /ID# 264555
  • Florida
    • Coral Gables, Florida, United States, 33134-5755
      • Florida Academic Dermatology Center /ID# 264065
    • Hollywood, Florida, United States, 33021-6748
      • Skin Care Research - Hollywood /ID# 255394
    • Margate, Florida, United States, 33063
      • GSI Clinical Research, LLC /ID# 255472
    • Miami, Florida, United States, 33137-3254
      • Skin and Cancer Associates, LLP /ID# 255506
    • Miami, Florida, United States, 33162
      • Sullivan Dermatology /ID# 264067
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research /ID# 255339
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Hamilton Research, LLC /ID# 255409
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research /ID# 255671
  • Illinois
    • Chicago, Illinois, United States, 60610
      • DeNova Research /ID# 264063
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology /ID# 255330
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center /ID# 255333
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Dermatology Partners of Leawood /ID# 263244
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates - Rockville /ID# 263252
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists /ID# 262929
  • Nevada
    • Sparks, Nevada, United States, 89436
      • Skin Cancer and Dermatology Institute (SCDI) /ID# 264570
  • New Jersey
    • Hoboken, New Jersey, United States, 07030
      • Care Access - Hoboken /ID# 264066
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group @ Union Turnpike /ID# 255346
    • New York, New York, United States, 07044-2946
      • Schweiger Dermatology, P.C. /ID# 255336
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Darst Dermatology /ID# 255848
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians Health Center /ID# 255395
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Clinical Research Center /ID# 263432
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center /ID# 255670
    • Portland, Oregon, United States, 97239
      • Oregon Medical Research Center /ID# 255332
  • Texas
    • Cypress, Texas, United States, 77429
      • Studies in Dermatology LLC /ID# 262989
    • Dallas, Texas, United States, 75231
      • Modern Research Associates /ID# 263234
    • Houston, Texas, United States, 77004-8097
      • Center for Clinical Studies - Houston (Binz) /ID# 255396
    • Longview, Texas, United States, 75601
      • U.S. Dermatology Partners Longview /ID# 266325
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research - San Antonio /ID# 263255
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies Webster TX /ID# 255518
  • Virginia
    • Danville, Virginia, United States, 24541
      • Care Access - Danville /ID# 266300
  • Washington
    • Kennewick, Washington, United States, 99336
      • Center for Excellence in Dermatology /ID# 264647
    • Mill Creek, Washington, United States, 98012
      • North Sound Dermatology /ID# 264565

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Study-G Placebo (Period A); Participants with moderate to severe genital psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.	Drug: Placebo for Risankizumab; Subcutaneous injection
Experimental: Study-G Risankizumab (Period A); Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.	Drug: Risankizumab; Subcutaneous injection; Other Names: ABBV-066; Skyrizi
Placebo Comparator: Study-S Placebo (Period A); Participants with moderate to severe scalp psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.	Drug: Placebo for Risankizumab; Subcutaneous injection
Experimental: Study-S Risankizumab (Period A); Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.	Drug: Risankizumab; Subcutaneous injection; Other Names: ABBV-066; Skyrizi
Experimental: Study-G Placebo/Risankizumab (Period B); 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; Subcutaneous injection; Other Names: ABBV-066; Skyrizi
Experimental: Study-G Risankizumab/Risankizumab (Period B); 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; Subcutaneous injection; Other Names: ABBV-066; Skyrizi
Experimental: Study-S Placebo/Risankizumab (Period B); 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; Subcutaneous injection; Other Names: ABBV-066; Skyrizi
Experimental: Study-S Risankizumab/Risankizumab (Period B); 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; Subcutaneous injection; Other Names: ABBV-066; Skyrizi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 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 all psoriatic lesions.	Week 16
Study-G: Percentage of Participants With Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16	The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment) and has a 1-week recall period. The response options range from 0 (not affected at all) to 3 (very much affected). This gives an overall range of 0 to 30 where lower scores mean better quality of life.	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]	The scalp Itch NRS is a self-administered NRS that asks participants to assess their scalp itch on a scale from 0 to 10 where 0 represents no itch and 10 represents worst imaginable itch.	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]	The GenPs-SFQ is a patient-reported outcome(s) [PRO] measure to evaluate the impact of genital psoriasis symptoms on sexual frequency, using a 1-week recall period. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Each item uses a Likert scale. Respondents are asked to answer the questions based on their psoriasis symptoms in the genital area. Genital area is defined as the labia majora (outer lip), labia minora (inner lip), and perineum (area between vagina and anus) for females; penis, scrotum, and perineum (area between the penis and anus) for males. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with response options ranging from 0 (never) to 4 (always).	Baseline, Week 16
Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16	PSSI 90 is defined as ≥ 90% improvement from Baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72, with higher scores indicating more severe disease.	Baseline, Week 16
Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index 75 (PSSI 75) at Week 16	PSSI 75 is defined as ≥ 75% improvement from Baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72, with higher scores indicating more severe disease.	Baseline, Week 16
Study-S: Change From Baseline in Psoriasis Symptom Scale (PSS) at Week 16	The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis, using a recall period of 1 day. The symptoms include pain, redness, itching and burning from psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe), with total scores, which is the sum of the four item responses, ranging from 0 to 16 and higher scores indicating worse symptoms. Negative changes from Baseline indicate improvement.	Baseline, Week 16
Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index (PSSI 100) at Week 16	PSSI 100 is defined as ≥ 100% improvement from Baseline in PSSI. The physician will assess the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is calculated as the sum of the scores for erythema, induration and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72, with higher scores indicating more severe disease.	Baseline, Week 16
Study-S: Percentage of Participants With Achievement of Psoriasis Symptom Scale (PSS) of 0 at Week 16	The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis, using a recall period of 1 day. The symptoms include pain, redness, itching and burning from psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe).	Week 16

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): January 22, 2025
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Scalp Psoriasis; Risankizumab; Skyrizi; Genital Psoriasis; ABBV066
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Immunologic Factors; Physiological Effects of Drugs; risankizumab
• Other Study ID Numbers: M23-702; 2023-504154-35-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes