Genital PsoriasisPhase 4UnlIMMitedNCT05969223
Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
A Phase 4 study testing Risankizumab in people with Genital Psoriasis and Scalp Psoriasis, run by AbbVie at 38 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genital Psoriasis, Scalp Psoriasis
- What is being tested?
- Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 38 sitesUnited States
- Study dates
- 10 Aug 2023to 28 Nov 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Hamilton Research, LLC /ID# 255409
Alpharetta, Georgia, 30022
Treasure Valley Medical Research /ID# 255671
Boise, Idaho, 83706
Darst Dermatology /ID# 255848
Charlotte, North Carolina, 28277
DeNova Research /ID# 264063
Chicago, Illinois, 60610
Florida Academic Dermatology Center /ID# 264065
Coral Gables, Florida, 33134-5755
Studies in Dermatology LLC /ID# 262989
Cypress, Texas, 77429
Modern Research Associates /ID# 263234
Dallas, Texas, 75231
Care Access - Danville /ID# 266300
Danville, Virginia, 24541
Private Practice - Dr. Tooraj Raoof /ID# 255334
Encino, California, 91436
Wright State Physicians Health Center /ID# 255395
Fairborn, Ohio, 45324
Care Access - Hoboken /ID# 264066
Hoboken, New Jersey, 07030
Skin Care Research - Hollywood /ID# 255394
Hollywood, Florida, 33021-6748
Center for Clinical Studies - Houston (Binz) /ID# 255396
Houston, Texas, 77004-8097
Center for Excellence in Dermatology /ID# 264647
Kennewick, Washington, 99336
Forest Hills Dermatology Group @ Union Turnpike /ID# 255346
Kew Gardens, New York, 11415
Dermatology Partners of Leawood /ID# 263244
Leawood, Kansas, 66211
U.S. Dermatology Partners Longview /ID# 266325
Longview, Texas, 75601
Dermatology Research Associates /ID# 255347
Los Angeles, California, 90045
GSI Clinical Research, LLC /ID# 255472
Margate, Florida, 33063
Apex Clinical Research Center /ID# 263432
Mayfield Heights, Ohio, 44124
Skin and Cancer Associates, LLP /ID# 255506
Miami, Florida, 33137-3254
Sullivan Dermatology /ID# 264067
Miami, Florida, 33162
North Sound Dermatology /ID# 264565
Mill Creek, Washington, 98012
Schweiger Dermatology, P.C. /ID# 255336
New York, New York, 07044-2946
Renstar Medical Research /ID# 255339
Ocala, Florida, 34470
Skin Specialists /ID# 262929
Omaha, Nebraska, 68144
Medical Dermatology Specialists /ID# 262915
Phoenix, Arizona, 85006
Alliance Dermatology and Mohs Center /ID# 255846
Phoenix, Arizona, 85032
The Indiana Clinical Trials Center /ID# 255333
Plainfield, Indiana, 46168
Oregon Dermatology and Research Center /ID# 255670
Portland, Oregon, 97210
Oregon Medical Research Center /ID# 255332
Portland, Oregon, 97239
DermAssociates - Rockville /ID# 263252
Rockville, Maryland, 20850
Arlington Dermatology /ID# 255330
Rolling Meadows, Illinois, 60008
Progressive Clinical Research - San Antonio /ID# 263255
San Antonio, Texas, 78229
Skin Cancer and Dermatology Institute (SCDI) /ID# 264570
Sparks, Nevada, 89436
Clinical Trials Research Institute /ID# 264555
Thousand Oaks, California, 91320-2130
Banner University Medicine Dermatology /ID# 255845
Tucson, Arizona, 85718-1407
Center for Clinical Studies Webster TX /ID# 255518
Webster, Texas, 77598
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Genital Psoriasis, Scalp Psoriasis
- Being tested
- Risankizumab, Placebo for Risankizumab
- Keywords
- Genital Psoriasis, Scalp Psoriasis, Plaque Psoriasis, Psoriasis, ABBV066, Skyrizi, Risankizumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Also called Skyrizi, ABBV-066
Subcutaneous injection
Placebo for RisankizumabDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start10 Aug 2023
- Primary completion22 Jan 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genital PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969223
- Sponsor's protocol ID
- M23-702
- Other IDs
- 2023-504154-35-00, 2023
- Acronym
- UnlIMMited
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2023
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 41139175
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05969223
- Acronym / sponsor ID
- UnlIMMited / M23-702
- Conditions
- Genital Psoriasis, Scalp Psoriasis
- Keywords
- Genital Psoriasis, Scalp Psoriasis, Plaque Psoriasis, Psoriasis, ABBV066, Skyrizi, Risankizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Study-G Placebo (Period A) | Placebo comparator | Drug: Placebo for RisankizumabParticipants with moderate to severe genital psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A. |
| Study-G Risankizumab (Period A) | Experimental | Drug: RisankizumabParticipants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A. |
| Study-S Placebo (Period A) | Placebo comparator | Drug: Placebo for RisankizumabParticipants with moderate to severe scalp psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A. |
| Study-S Risankizumab (Period A) | Experimental | Drug: RisankizumabParticipants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A. |
| Study-G Placebo/Risankizumab (Period B) | Experimental | Drug: RisankizumabParticipants 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. |
| Study-G Risankizumab/Risankizumab (Period B) | Experimental | Drug: RisankizumabParticipants 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. |
| Study-S Placebo/Risankizumab (Period B) | Experimental | Drug: RisankizumabParticipants 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. |
| Study-S Risankizumab/Risankizumab (Period B) | Experimental | Drug: RisankizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisankizumabAlso: Skyrizi, ABBV-066Subcutaneous injection | Drug | 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 RisankizumabSubcutaneous injection | Drug | Study-G Placebo (Period A), Study-S Placebo (Period A) |
Primary outcome
Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 at Week 16
Time frame: 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.
Study-S: Percentage of Participants With Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1 at Week 16
Time frame: 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.
9 secondary outcomes
Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 at Week 16
Time frame: Week 16
Study-G: Percentage of Participants With Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16
Time frame: 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]
Time frame: 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]
Time frame: Baseline, Week 16
Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16
Time frame: Baseline, Week 16
Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index 75 (PSSI 75) at Week 16
Time frame: Baseline, Week 16
Study-S: Change From Baseline in Psoriasis Symptom Scale (PSS) at Week 16
Time frame: Baseline, Week 16
Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index (PSSI 100) at Week 16
Time frame: Baseline, Week 16
Study-S: Percentage of Participants With Achievement of Psoriasis Symptom Scale (PSS) of 0 at Week 16
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41139175Song 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risankizumab in people with Genital Psoriasis and Scalp Psoriasis, run by AbbVie at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 at Week 16 (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05969223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.