Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

200

Study ID:

NCT05969223

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 30 Locations for this study

See Locations Near You

Medical Dermatology Specialists /ID# 262915
Phoenix Arizona, 85006, United States More Info
Site Coordinator
Contact
602-354-3770
Alliance Dermatology and MOHs Center, PC /ID# 255846
Phoenix Arizona, 85032, United States
Banner University Medicine Dermatology /ID# 255845
Tucson Arizona, 85718, United States
Joseph Raoof Md,Inc /Id# 255334
Encino California, 91436, United States
Dermatology Research Associates /ID# 255347
Los Angeles California, 90045, United States More Info
Site Coordinator
Contact
310-337-7171
Skin Care Research - Hollywood /ID# 255394
Hollywood Florida, 33021, United States More Info
Site Coordinator
Contact
+1-561-948-3116
GSI Clinical Research, LLC /ID# 255472
Margate Florida, 33063, United States
Skin and Cancer Associates, LLP /ID# 255506
Miami Florida, 33137, 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, 60611, United States More Info
Site Coordinator
Contact
312-585-7299
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 More Info
Site Coordinator
Contact
301-355-3183
Skin Specialists /ID# 262929
Omaha Nebraska, 68144, United States
Forest Hills Dermatology Group @ Union Turnpike /ID# 255346
Kew Gardens New York, 11415, United States More Info
Site Coordinator
Contact
718-459-0900
Schweiger Dermatology, P.C. /ID# 255336
Verona New York, 07044, United States
Darst Dermatology /ID# 255848
Charlotte North Carolina, 28277, United States More Info
Site Coordinator
Contact
704-321-3376
Wright State Physicians - Fairborn /ID# 255395
Fairborn Ohio, 45324, United States More Info
Site Coordinator
Contact
937-245-7500
Apex Clinical Research Center /ID# 263432
Mayfield Heights Ohio, 44124, United States
Oregon Dermatology and Research Center /ID# 255670
Portland Oregon, 97210, United States More Info
Site Coordinator
Contact
503-222-7546
Oregon Medical Research Center /ID# 255332
Portland Oregon, 97239, United States More Info
Site Coordinator
Contact
503-245-1525
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, 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 More Info
Site Coordinator
Contact
(281) 343-3300
North Sound Dermatology /ID# 264565
Mill Creek Washington, 98012, United States More Info
Site Coordinator
Contact
425-275-4404

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

200

Study ID:

NCT05969223

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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