Back to resultsStudy 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
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risankizumab
Apremilast
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Plaque Psoriasis, Risankizumab, ABBV-066, Skyrizi, Apremilast
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.
Sites / Locations
- Total Skin and Beauty Derm Ctr /ID# 233793
- Advanced Research Associates - Glendale /ID# 229266
- Alliance Dermatology and MOH Center, PC /ID# 229224
- UC Davis Health /ID# 229133
- Florida Academic Centers Research and Education /ID# 229235
- Olympian Clinical Research - Largo /ID# 233792
- Renstar Medical Research /ID# 228946
- ForCare Clinical Research /ID# 229135
- Arlington Dermatology /ID# 228945
- Dawes Fretzin, LLC /ID# 229010
- Epiphany Dermatology of Kansas LLC /ID# 229221
- DermAssociates, LLC /ID# 229016
- Michigan Center for Research Company /ID# 229136
- Henry Ford Medical Center /ID# 229215
- MediSearch Clinical Trials /ID# 229269
- Physician Research Collaboration, LLC /ID# 229225
- Advanced Dermatology of the Midlands /ID# 229009
- Psoriasis Treatment Center of Central New Jersey /ID# 228943
- University Hospitals Case Medical Center /ID# 229240
- Wright State Physicians - Fairborn /ID# 230051
- Oregon Dermatology and Research Center /ID# 233462
- Arlington Research Center, Inc /ID# 229264
- Bellaire Dermatology Associates /ID# 230118
- Center for Clinical Studies - Houston (Binz) /ID# 229263
- Center for Clinical Studies - Houston (Binz) /ID# 229272
- Premier Clinical Research /ID# 229220
- Beacon Dermatology Inc /ID# 230121
- Dr. Chih-ho Hong Medical Inc. /ID# 230337
- Enverus Medical Research /ID# 230480
- Karma Clinical Trials /ID# 230339
- Dermatrials Research /ID# 230119
- Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416
- K. Papp Clinical Research /ID# 230336
- Innovaderm Research Inc. /ID# 230334
- Centre de recheche dermatologique du Quebec Metropolitain /ID# 230478
- Universitaetsklinikum Erlangen /ID# 229433
- Universitaetsklinikum Frankfurt /ID# 229431
- Universitaetsklinikum Muenster /ID# 229432
- DermaKiel Allergie und Haut Centrum /ID# 229630
- Fachklinik Bad Bentheim /ID# 231504
- Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245
- SRH Wald-Klinikum Gera /ID# 229445
- MENSINGDERMA research GmbH /ID# 229435
- Dermatologische Gemeinschaftspraxis Mahlow /ID# 229434
- The Chaim Sheba Medical Center /ID# 229075
- HaEmek Medical Center /ID# 231901
- Rambam Health Care Campus /ID# 229620
- Rabin Medical Center /ID# 229074
- Dermed Centrum Medyczne Sp. z o.o /ID# 229051
- High-Med Przychodnia Specjalistyczna /ID# 229023
- Royalderm Agnieszka Nawrocka /ID# 228973
- Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022
- Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053
- Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Arm 1: Risankizumab
Arm 2a: Apremilast/Risankizumab
Arm 2b: Apremilast
Arm Description
Participants will receive risankizumab Dose A in Period A and Period B.
Participants will receive apremilast Dose A in Period A followed by risankizumab Dose A in Period B.
Participants will receive apremilast Dose A in Period A and Period B. Non-responders at Week 28 and Week 40 will be offered to receive risankizumab Dose A.
Outcomes
Primary Outcome Measures
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 in Period A (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, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72.
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 in Period A (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).
Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Period B Non-Responders (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, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72.
Secondary Outcome Measures
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population in Period A (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, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72.
Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Period B Non-Responders (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, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72.
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 Period B Non-Responders (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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04908475
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Plaque Psoriasis, Risankizumab, ABBV-066, Skyrizi, Apremilast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Risankizumab
Arm Type
Experimental
Arm Description
Participants will receive risankizumab Dose A in Period A and Period B.
Arm Title
Arm 2a: Apremilast/Risankizumab
Arm Type
Experimental
Arm Description
Participants will receive apremilast Dose A in Period A followed by risankizumab Dose A in Period B.
Arm Title
Arm 2b: Apremilast
Arm Type
Active Comparator
Arm Description
Participants will receive apremilast Dose A in Period A and Period B. Non-responders at Week 28 and Week 40 will be offered to receive risankizumab Dose A.
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, Skyrizi
Intervention Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
Otezla
Intervention Description
Oral Tablets
Primary Outcome Measure Information:
Title
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 in Period A (ITT_A)
Description
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, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72.
Time Frame
Week 16
Title
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 in Period A (ITT_A)
Description
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).
Time Frame
Week 16
Title
Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Period B Non-Responders (ITT_B_NR)
Description
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, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population in Period A (ITT_A)
Description
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, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72.
Time Frame
Week 16
Title
Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Period B Non-Responders (ITT_B_NR)
Description
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, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72.
Time Frame
Week 52
Title
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 Period B Non-Responders (ITT_B_NR)
Description
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).
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Derm Ctr /ID# 233793
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Advanced Research Associates - Glendale /ID# 229266
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Alliance Dermatology and MOH Center, PC /ID# 229224
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
UC Davis Health /ID# 229133
City
Sacramento
State/Province
California
ZIP/Postal Code
95816-3300
Country
United States
Facility Name
Florida Academic Centers Research and Education /ID# 229235
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Olympian Clinical Research - Largo /ID# 233792
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Renstar Medical Research /ID# 228946
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
ForCare Clinical Research /ID# 229135
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Arlington Dermatology /ID# 228945
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Dawes Fretzin, LLC /ID# 229010
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Epiphany Dermatology of Kansas LLC /ID# 229221
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
DermAssociates, LLC /ID# 229016
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Michigan Center for Research Company /ID# 229136
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Henry Ford Medical Center /ID# 229215
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-3046
Country
United States
Facility Name
MediSearch Clinical Trials /ID# 229269
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Physician Research Collaboration, LLC /ID# 229225
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Advanced Dermatology of the Midlands /ID# 229009
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144-1105
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey /ID# 228943
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
University Hospitals Case Medical Center /ID# 229240
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Wright State Physicians - Fairborn /ID# 230051
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324-2640
Country
United States
Facility Name
Oregon Dermatology and Research Center /ID# 233462
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Arlington Research Center, Inc /ID# 229264
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Bellaire Dermatology Associates /ID# 230118
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Center for Clinical Studies - Houston (Binz) /ID# 229263
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-8097
Country
United States
Facility Name
Center for Clinical Studies - Houston (Binz) /ID# 229272
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-8097
Country
United States
Facility Name
Premier Clinical Research /ID# 229220
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Beacon Dermatology Inc /ID# 230121
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc. /ID# 230337
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Enverus Medical Research /ID# 230480
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Karma Clinical Trials /ID# 230339
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
Dermatrials Research /ID# 230119
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
K. Papp Clinical Research /ID# 230336
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Innovaderm Research Inc. /ID# 230334
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Centre de recheche dermatologique du Quebec Metropolitain /ID# 230478
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Universitaetsklinikum Erlangen /ID# 229433
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 229431
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Muenster /ID# 229432
City
Munster
State/Province
Niedersachsen
ZIP/Postal Code
48149
Country
Germany
Facility Name
DermaKiel Allergie und Haut Centrum /ID# 229630
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24148
Country
Germany
Facility Name
Fachklinik Bad Bentheim /ID# 231504
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
SRH Wald-Klinikum Gera /ID# 229445
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
MENSINGDERMA research GmbH /ID# 229435
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Dermatologische Gemeinschaftspraxis Mahlow /ID# 229434
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
The Chaim Sheba Medical Center /ID# 229075
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
HaEmek Medical Center /ID# 231901
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 229620
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rabin Medical Center /ID# 229074
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Dermed Centrum Medyczne Sp. z o.o /ID# 229051
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-265
Country
Poland
Facility Name
High-Med Przychodnia Specjalistyczna /ID# 229023
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Royalderm Agnieszka Nawrocka /ID# 228973
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971
City
Elblag
State/Province
Warminsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related Info
Learn more about this trial
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
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