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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908475
• Other study ID #: M20-326
• Secondary ID: 2020-005512-21
• Status: Completed
• Phase: Phase 4
• Start date: June 9, 2021
• Est. completion date: April 20, 2023

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Risankizumab
Subcutaneous injection
• Apremilast
Oral Tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Israel,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.	Week 16
Primary	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)	The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).	Week 16
Primary	Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.	Week 52
Secondary	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)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.	Week 16
Secondary	Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.	Week 52
Secondary	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)	The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).	Week 52

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