Clinical trial NCT05969223: Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Genital Psoriasis
Scalp Psoriasis
Keywords: Genital Psoriasis
Scalp Psoriasis
Plaque Psoriasis
Psoriasis
ABBV066
Skyrizi
Risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored.

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

The study will be broken up into 2 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1
timeFrame: Week 16
measure: Study-S: Percentage of Participants with Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1
timeFrame: Week 16
Secondary outcomes:
measure: Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0
timeFrame: Week 16
measure: Study-G: Percentage of Participants with Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1
timeFrame: Week 16
measure: 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]
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Study-S: Percentage of Participants with Achievement of Psoriasis Scalp Severity Index (PSSI 90)
timeFrame: Week 16
measure: Study-S: Percentage of Participants with Achievement of PSSI 75
timeFrame: Week 16
measure: Study-S: Change from Baseline in Psoriasis Symptom Scale (PSS)
timeFrame: Week 16
measure: Study-S: Percentage of Participants with Achievement of PSSI 100
timeFrame: Week 16
measure: Study-S: Percentage of Participants with Achievement of PSS of 0
timeFrame: Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists /ID# 262915
state: Arizona
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center /ID# 255846
state: Arizona
city: Tucson
country: United States
facility: Banner University Medicine Dermatology /ID# 255845
state: Arizona
city: Encino
country: United States
facility: Joseph Raoof Md,Inc /Id# 255334
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates /ID# 255347
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute /ID# 264555
state: California
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Center /ID# 264065
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research - Hollywood /ID# 255394
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC /ID# 255472
state: Florida
city: Miami
country: United States
facility: Skin and Cancer Associates, LLP /ID# 255506
state: Florida
city: Miami
country: United States
facility: Ziaderm Research LLC /ID# 264067
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research /ID# 255339
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research, LLC /ID# 255409
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research /ID# 255671
state: Idaho
city: Chicago
country: United States
facility: DeNova Research /ID# 264063
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 255330
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center /ID# 255333
state: Indiana
city: Leawood
country: United States
facility: Dermatology Partners of Leawood /ID# 263244
state: Kansas
city: Rockville
country: United States
facility: DermAssociates - Rockville /ID# 263252
state: Maryland
city: Omaha
country: United States
facility: Skin Specialists /ID# 262929
state: Nebraska
city: Sparks
country: United States
facility: Skin Cancer and Dermatology Institute (SCDI) /ID# 264570
state: Nevada
city: Hoboken
country: United States
facility: Care Access - Hoboken /ID# 264066
state: New Jersey
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group @ Union Turnpike /ID# 255346
state: New York
city: New York
country: United States
facility: Schweiger Dermatology, P.C. /ID# 255336
state: New York
city: Charlotte
country: United States
facility: Darst Dermatology /ID# 255848
state: North Carolina
city: Fairborn
country: United States
facility: Wright State Physicians Health Center /ID# 255395
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center /ID# 263432
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center /ID# 255670
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 255332
state: Oregon
city: Cypress
country: United States
facility: Studies in Dermatology LLC /ID# 262989
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates /ID# 263234
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 255396
state: Texas
city: Longview
country: United States
facility: U.S. Dermatology Partners Longview /ID# 266325
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research - San Antonio /ID# 263255
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies Webster TX /ID# 255518
state: Texas
city: Danville
country: United States
facility: Care Access - Danville /ID# 266300
state: Virginia
city: Kennewick
country: United States
facility: Center for Excellence in Dermatology /ID# 264647
state: Washington
city: Mill Creek
country: United States
facility: North Sound Dermatology /ID# 264565
state: Washington
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: