Clinical trial NCT04908475: Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
Official title: A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Risankizumab
ABBV-066
Skyrizi
Apremilast
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 352
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 compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored.

Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally.

The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Eligibility criteria: Inclusion Criteria:

- Candidates for systemic therapy with moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as:

* Body Surface Area (BSA) \>= 10% and \<= 15%; and
* Psoriasis Area and Severity Index (PASI) \>= 12; and
* Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4).

Exclusion Criteria:

* Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
* History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
* History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
* Prior exposure to risankizumab or apremilast.

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
timeFrame: Week 16
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
timeFrame: Week 52
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
timeFrame: Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center /ID# 233793
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 229266
state: Arizona
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHs Center, PC /ID# 229224
state: Arizona
city: Sacramento
country: United States
facility: UC Davis Health /ID# 229133
state: California
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education /ID# 229235
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research - Largo /ID# 233792
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research /ID# 228946
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 229135
state: Florida
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 228945
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 229010
state: Indiana
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas LLC /ID# 229221
state: Kansas
city: Rockville
country: United States
facility: DermAssociates, LLC /ID# 229016
state: Maryland
city: Clarkston
country: United States
facility: Michigan Center for Research Company /ID# 229136
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center /ID# 229215
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials /ID# 229269
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC /ID# 229225
state: Nebraska
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands /ID# 229009
state: Nebraska
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey /ID# 228943
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center /ID# 229240
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians - Fairborn /ID# 230051
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center /ID# 233462
state: Oregon
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 229264
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 230118
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 229263
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 229272
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 229220
state: Washington
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 230121
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 230337
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research /ID# 230480
state: British Columbia
city: St. John's
country: Canada
facility: Karma Clinical Trials /ID# 230339
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Dermatrials Research /ID# 230119
state: Ontario
city: Newmarket
country: Canada
facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research /ID# 230336
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research Inc. /ID# 230334
state: Quebec
city: Québec
country: Canada
facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 230478
state: Quebec
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 229433
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 229431
state: Hessen
city: Munster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 229432
state: Niedersachsen
city: Kiel
country: Germany
facility: DermaKiel Allergie und Haut Centrum /ID# 229630
state: Schleswig-Holstein
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim /ID# 231504
city: Bochum
country: Germany
facility: Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera /ID# 229445
city: Hamburg
country: Germany
facility: MENSINGDERMA research GmbH /ID# 229435
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 229434
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 229620
state: H_efa
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 229074
state: H_efa
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 231901
state: HaDarom
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 229075
state: Tel-Aviv
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp. z o.o /ID# 229051
state: Lodzkie
city: Warszawa
country: Poland
facility: High-Med Przychodnia Specjalistyczna /ID# 229023
state: Mazowieckie
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka /ID# 228973
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022
state: Podkarpackie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053
state: Pomorskie
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971
state: Warminsko-mazurskie
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: