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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504154-35-00 | Other Identifier | EU CT |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous injection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists /ID# 262915 | Phoenix | Arizona | 85006 | United States | ||
| Alliance Dermatology and Mohs Center /ID# 255846 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41139175 | Derived | 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. |
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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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Participants within Study-G and Study-S were randomized to receive risankizumab or placebo in a 1:1 ratio. Those meeting criteria for both Study-G and Study-S were first randomized to either Study-G or Study-S and then to receive either risankizumab or placebo. Participants received 150 mg of risankizumab or matching placebo subcutaneously at Weeks 0 and 4 during Period A. During Period B, all participants received/will continue to receive open-label 150 mg risankizumab at Weeks 16, 28, and 40.
This study was conducted at 30 sites in the United States with a total of 214 participants and was initiated in August 2023. Adults with with moderate to severe genital (Study-G) or scalp (Study-S) psoriasis were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Study-G Risankizumab (Period A) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period A (Week 0-16) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2023 | Dec 29, 2025 |
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| 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. |
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| 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. |
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| 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. |
|
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| Placebo for Risankizumab | Drug | Subcutaneous injection |
|
| 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 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Banner University Medicine Dermatology /ID# 255845 | Tucson | Arizona | 85718-1407 | United States |
| Private Practice - Dr. Tooraj Raoof /ID# 255334 | Encino | California | 91436 | United States |
| Dermatology Research Associates /ID# 255347 | Los Angeles | California | 90045 | United States |
| Clinical Trials Research Institute /ID# 264555 | Thousand Oaks | California | 91320-2130 | United States |
| Florida Academic Dermatology Center /ID# 264065 | Coral Gables | Florida | 33134-5755 | United States |
| Skin Care Research - Hollywood /ID# 255394 | Hollywood | Florida | 33021-6748 | United States |
| GSI Clinical Research, LLC /ID# 255472 | Margate | Florida | 33063 | United States |
| Skin and Cancer Associates, LLP /ID# 255506 | Miami | Florida | 33137-3254 | United States |
| Sullivan Dermatology /ID# 264067 | Miami | Florida | 33162 | United States |
| Renstar Medical Research /ID# 255339 | Ocala | Florida | 34470 | United States |
| Hamilton Research, LLC /ID# 255409 | Alpharetta | Georgia | 30022 | United States |
| Treasure Valley Medical Research /ID# 255671 | Boise | Idaho | 83706 | United States |
| DeNova Research /ID# 264063 | Chicago | Illinois | 60610 | United States |
| Arlington Dermatology /ID# 255330 | Rolling Meadows | Illinois | 60008 | United States |
| The Indiana Clinical Trials Center /ID# 255333 | Plainfield | Indiana | 46168 | United States |
| Dermatology Partners of Leawood /ID# 263244 | Leawood | Kansas | 66211 | United States |
| DermAssociates - Rockville /ID# 263252 | Rockville | Maryland | 20850 | United States |
| Skin Specialists /ID# 262929 | Omaha | Nebraska | 68144 | United States |
| Skin Cancer and Dermatology Institute (SCDI) /ID# 264570 | Sparks | Nevada | 89436 | United States |
| Care Access - Hoboken /ID# 264066 | Hoboken | New Jersey | 07030 | United States |
| Forest Hills Dermatology Group @ Union Turnpike /ID# 255346 | Kew Gardens | New York | 11415 | United States |
| Schweiger Dermatology, P.C. /ID# 255336 | New York | New York | 07044-2946 | United States |
| Darst Dermatology /ID# 255848 | Charlotte | North Carolina | 28277 | United States |
| Wright State Physicians Health Center /ID# 255395 | Fairborn | Ohio | 45324 | United States |
| Apex Clinical Research Center /ID# 263432 | Mayfield Heights | Ohio | 44124 | United States |
| Oregon Dermatology and Research Center /ID# 255670 | Portland | Oregon | 97210 | United States |
| Oregon Medical Research Center /ID# 255332 | Portland | Oregon | 97239 | United States |
| Studies in Dermatology LLC /ID# 262989 | Cypress | Texas | 77429 | United States |
| Modern Research Associates /ID# 263234 | Dallas | Texas | 75231 | United States |
| Center for Clinical Studies - Houston (Binz) /ID# 255396 | Houston | Texas | 77004-8097 | United States |
| U.S. Dermatology Partners Longview /ID# 266325 | Longview | Texas | 75601 | United States |
| Progressive Clinical Research - San Antonio /ID# 263255 | San Antonio | Texas | 78229 | United States |
| Center for Clinical Studies Webster TX /ID# 255518 | Webster | Texas | 77598 | United States |
| Care Access - Danville /ID# 266300 | Danville | Virginia | 24541 | United States |
| Center for Excellence in Dermatology /ID# 264647 | Kennewick | Washington | 99336 | United States |
| North Sound Dermatology /ID# 264565 | Mill Creek | Washington | 98012 | United States |
Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Period B (Week 16-52) |
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Intent-to-Treat Population (ITT):
ITT_G (participants randomized in Study-G); ITT_S (participants randomized in Study-S)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | ITT_G: all participants randomized in Study-G; non-responder Imputation (NRI) was used to handle missing values | Posted | Number | percentage of participants | Week 16 |
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| Primary | 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. | ITT_S: all participants randomized in Study-S; non-responder Imputation (NRI) was used to handle missing values | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | 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. | ITT_G: all participants randomized in Study-G; Non-responder Imputation (NRI) was used to handle missing values | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | 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. | ITT_G: all participants randomized in Study-G; Non-responder Imputation (NRI) was used to handle missing values | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | 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. | ITT_G: all participants randomized in Study-G; Non-responder Imputation (NRI) was used to handle missing values; participants with Baseline score ≥ 4 | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Secondary | 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). | ITT_G: all participants randomized in Study-G; Non-responder Imputation (NRI) was used to handle missing values; participants with Baseline score ≥ 2 | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Secondary | 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. | ITT_S: all participants randomized in Study-S; non-responder Imputation (NRI) was used to handle missing values | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Secondary | 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. | ITT_S: all participants randomized in Study-S; non-responder Imputation (NRI) was used to handle missing values | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Secondary | 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. | ITT_S: all participants randomized in Study-S; those with non-missing Baseline and at least one post-baseline value is included in the analyses | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 16 |
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| Secondary | 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. | ITT_S: all participants randomized in Study-S; non-responder Imputation (NRI) was used to handle missing values | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Secondary | 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). | ITT_S: all participants randomized in Study-S; non-responder Imputation (NRI) was used to handle missing values | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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All-cause mortality and adverse event tables include events reported from time informed consent was signed through 22 January 2025, after all participants completed Week 16 of Study-G or Study-S in Period A. Median time on follow-up in Period A was 112 days for all groups. Median time on follow-up in Period B ranged from 136 to 142 days in Study-G and 260 to 285 days in Study-S.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 54 | 1 | 54 | 8 | 54 |
| EG001 | 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 | 0 | 55 | 1 | 55 | 8 | 55 |
| EG002 | 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. | 0 | 54 | 1 | 54 | 7 | 54 |
| EG003 | 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. | 0 | 51 | 3 | 51 | 9 | 51 |
| EG004 | 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. | 0 | 53 | 1 | 53 | 8 | 53 |
| EG005 | 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. | 0 | 54 | 1 | 54 | 8 | 54 |
| EG006 | 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. | 0 | 48 | 1 | 48 | 7 | 48 |
| EG007 | 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. | 0 | 51 | 3 | 51 | 9 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2025 | Dec 29, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000601773 | risankizumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
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| Other, not specified |
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| Ongoing in Period B |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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