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

Scalp Psoriasis Clinical Trial

— UnlIMMited  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05969223
• Other study ID #: M23-702
• Secondary ID: 2023-504154-35-0
• Status: Recruiting
• Phase: Phase 4
• Start date: August 10, 2023
• Est. completion date: October 6, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Adverse events and change in disease signs and symptoms will be monitored.

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

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

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 6, 2025
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genital Psoriasis
• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• Risankizumab
Subcutaneous injection
• Placebo for Risankizumab
Subcutaneous injection

Locations

Country	Name	City	State
United States	Hamilton Research, LLC /ID# 255409	Alpharetta	Georgia
United States	Treasure Valley Medical Research /ID# 255671	Boise	Idaho
United States	Darst Dermatology /ID# 255848	Charlotte	North Carolina
United States	DeNova Research /ID# 264063	Chicago	Illinois
United States	Florida Academic Dermatology Center /ID# 264065	Coral Gables	Florida
United States	Studies in Dermatology LLC /ID# 262989	Cypress	Texas
United States	Modern Research Associates /ID# 263234	Dallas	Texas
United States	Joseph Raoof Md,Inc /Id# 255334	Encino	California
United States	Wright State Physicians - Fairborn /ID# 255395	Fairborn	Ohio
United States	Care Access - Hoboken /ID# 264066	Hoboken	New Jersey
United States	Skin Care Research - Hollywood /ID# 255394	Hollywood	Florida
United States	Center for Clinical Studies - Houston (Binz) /ID# 255396	Houston	Texas
United States	Forest Hills Dermatology Group @ Union Turnpike /ID# 255346	Kew Gardens	New York
United States	Dermatology Partners of Leawood /ID# 263244	Leawood	Kansas
United States	US Dermatology Partners Longview /ID# 266325	Longview	Texas
United States	Dermatology Research Associates /ID# 255347	Los Angeles	California
United States	GSI Clinical Research, LLC /ID# 255472	Margate	Florida
United States	Apex Clinical Research Center /ID# 263432	Mayfield Heights	Ohio
United States	Skin and Cancer Associates, LLP /ID# 255506	Miami	Florida
United States	Ziaderm Research LLC /ID# 264067	Miami	Florida
United States	North Sound Dermatology /ID# 264565	Mill Creek	Washington
United States	Renstar Medical Research /ID# 255339	Ocala	Florida
United States	Skin Specialists /ID# 262929	Omaha	Nebraska
United States	Alliance Dermatology and Mohs Center /ID# 255846	Phoenix	Arizona
United States	Medical Dermatology Specialists /ID# 262915	Phoenix	Arizona
United States	The Indiana Clinical Trials Center /ID# 255333	Plainfield	Indiana
United States	Oregon Dermatology and Research Center /ID# 255670	Portland	Oregon
United States	Oregon Medical Research Center /ID# 255332	Portland	Oregon
United States	DermAssociates - Rockville /ID# 263252	Rockville	Maryland
United States	Arlington Dermatology /ID# 255330	Rolling Meadows	Illinois
United States	Progressive Clinical Research - San Antonio /ID# 263255	San Antonio	Texas
United States	Clinical Trials Research Institute /ID# 264555	Thousand Oaks	California
United States	Banner University Medicine Dermatology /ID# 255845	Tucson	Arizona
United States	Schweiger Dermatology, P.C. /ID# 255336	Verona	New York
United States	Center for Clinical Studies Webster TX /ID# 255518	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1	The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.	Week 16
Primary	Study-S: Percentage of Participants with Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1	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.	Week 16
Secondary	Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0	The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.	Week 16
Secondary	Study-G: Percentage of Participants with Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1	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
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) [Among Participants with a Baseline Score >= 4]	The scalp Itch NRS is a self-administered NRS that asks the patients to assess their scalp itch on a scale from 0 to 10 where 0 represents no itch and 10 represents worst imaginable itch.	Week 16
Secondary	Study-G: Percentage of Participants with Achievement of Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 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.	Week 16
Secondary	Study-S: Percentage of Participants with Achievement of Psoriasis Scalp Severity Index (PSSI 90)	PPSI 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 0 (<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.	Week 16
Secondary	Study-S: Percentage of Participants with Achievement of PSSI 75	PPSI 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 0 (<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.	Week 16
Secondary	Study-S: Change from Baseline in Psoriasis Symptom Scale (PSS)	The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in patients 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
Secondary	Study-S: Percentage of Participants with Achievement of PSSI 100	PPSI 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 0 (<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.	Week 16
Secondary	Study-S: Percentage of Participants with Achievement of PSS of 0	The PSS is a 4-item PRO instrument that assesses the severity of psoriasis symptoms in patients 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

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