Study of Subcutaneous Risankizumab Injection Compared to... | NCT04908475 | Trialant
NCT04908475
Sponsor
AbbVie
Status
Completed
Last Update Posted
Apr 30, 2024Actual
Enrollment
352Actual
Phase
Phase 4
Conditions
Psoriasis
Interventions
Risankizumab
Apremilast
Countries
United States
Canada
Germany
Israel
Poland
Protocol Section
Identification Module
NCT ID
NCT04908475
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M20-326
Secondary IDs
ID
Type
Description
Link
2020-005512-21
EudraCT Number
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
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Apr 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 9, 2021Actual
Primary Completion Date
Apr 20, 2023Actual
Completion Date
Apr 20, 2023Actual
First Submitted Date
May 28, 2021
First Submission Date that Met QC Criteria
May 28, 2021
First Posted Date
Jun 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Apr 2, 2024
Results First Submitted that Met QC Criteria
Apr 2, 2024
Results First Posted Date
Apr 30, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 2, 2024
Last Update Posted Date
Apr 30, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Psoriasis
Plaque Psoriasis
Risankizumab
ABBV-066
Skyrizi
Apremilast
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
352Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Risankizumab
Experimental
Risankizumab 150 mg as a single subcutaneous (SC) injection at at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B).
Drug: Risankizumab
Apremilast
Experimental
Participants receive apremilast 30 mg orally twice daily (BID) in Period A and re-randomized to receive either risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32 in Period B or apremilast 30 mg orally BID from Week 16 up to Week 52 in Period B. For those taking apremilast in Period B, non-responders at Week 28 and Week 40 will be offered to receive risankizumab as rescue medication.
Drug: Risankizumab
Drug: Apremilast
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Risankizumab
Drug
Subcutaneous injection
Apremilast
Risankizumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
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
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 Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Total Skin and Beauty Dermatology Center /ID# 233793
Birmingham
Alabama
35205
United States
Advanced Research Associates - Glendale /ID# 229266
Stein Gold LF, Bagel J, Tyring SK, Hong HC, Pavlovsky L, Vender R, Pinter A, Reich A, Drogaris L, Wu T, Patel M, Soliman AM, Photowala H, Stakias V, Richter S, Papp KA. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse). Br J Dermatol. 2023 Oct 25;189(5):540-552. doi: 10.1093/bjd/ljad252.
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.
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/
Period A: participants were randomized in a 1:2 ratio to risankizumab (RZB) or apremilast (APR). Period B: participants receiving RZB were continued up to Week 52; participants receiving APR were re-randomized in a 1:1 ratio to receive either RZB or APR (with the option to receive RZB as rescue) up to Week 52. Rerandomization was stratified by Psoriasis Area and Severity Index (PASI) 75 response (responder, non-responder) at Week 16.
Recruitment Details
A total of 352 participants were enrolled from 48 sites across 5 countries including Canada, Germany, Israel, Poland, and the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Period A: APR
Apremilast 30 mg orally twice daily (BID) up to Week 16
FG001
Periods A/B: RZB/RZB
Risankizumab 150 mg as a single subcutaneous (SC) injection at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B).
Periods
Title
Milestones
Reasons Not Completed
Period A (Baseline to Week 16)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 10, 2022
Apr 2, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Outcomes Assessor
ABBV-066
Skyrizi
Apremilast
Drug
Oral Tablets
Apremilast
Otezla
Week 16
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
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
Glendale
Arizona
85308
United States
Alliance Dermatology and MOHs Center, PC /ID# 229224
Phoenix
Arizona
85032
United States
UC Davis Health /ID# 229133
Sacramento
California
95816-3300
United States
Florida Academic Centers Research and Education /ID# 229235
Coral Gables
Florida
33134
United States
Olympian Clinical Research - Largo /ID# 233792
Largo
Florida
33770
United States
Renstar Medical Research /ID# 228946
Ocala
Florida
34470
United States
ForCare Clinical Research /ID# 229135
Tampa
Florida
33613-1244
United States
Arlington Dermatology /ID# 228945
Rolling Meadows
Illinois
60008
United States
Dawes Fretzin, LLC /ID# 229010
Indianapolis
Indiana
46256
United States
Epiphany Dermatology of Kansas LLC /ID# 229221
Overland Park
Kansas
66210
United States
DermAssociates, LLC /ID# 229016
Rockville
Maryland
20850
United States
Michigan Center for Research Company /ID# 229136
Clarkston
Michigan
48346
United States
Henry Ford Medical Center /ID# 229215
Detroit
Michigan
48202-3046
United States
MediSearch Clinical Trials /ID# 229269
Saint Joseph
Missouri
64506
United States
Physician Research Collaboration, LLC /ID# 229225
Lincoln
Nebraska
68516
United States
Advanced Dermatology of the Midlands /ID# 229009
Omaha
Nebraska
68144-1105
United States
Psoriasis Treatment Center of Central New Jersey /ID# 228943
East Windsor
New Jersey
08520
United States
University Hospitals Case Medical Center /ID# 229240
Cleveland
Ohio
44106
United States
Wright State Physicians - Fairborn /ID# 230051
Fairborn
Ohio
45324-2640
United States
Oregon Dermatology and Research Center /ID# 233462
Portland
Oregon
97210
United States
Arlington Research Center, Inc /ID# 229264
Arlington
Texas
76011
United States
Bellaire Dermatology Associates /ID# 230118
Bellaire
Texas
77401
United States
Center for Clinical Studies - Houston (Binz) /ID# 229263
Houston
Texas
77004-8097
United States
Center for Clinical Studies - Houston (Binz) /ID# 229272
Houston
Texas
77004-8097
United States
Premier Clinical Research /ID# 229220
Spokane
Washington
99202
United States
Beacon Dermatology Inc /ID# 230121
Calgary
Alberta
T3E 0B2
Canada
Dr. Chih-ho Hong Medical Inc. /ID# 230337
Surrey
British Columbia
V3R 6A7
Canada
Enverus Medical Research /ID# 230480
Surrey
British Columbia
V3V 0C6
Canada
Karma Clinical Trials /ID# 230339
St. John's
Newfoundland and Labrador
A1A 4Y3
Canada
Dermatrials Research /ID# 230119
Hamilton
Ontario
L8N 1Y2
Canada
Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416
Newmarket
Ontario
L3Y 5G8
Canada
K. Papp Clinical Research /ID# 230336
Waterloo
Ontario
N2J 1C4
Canada
Innovaderm Research Inc. /ID# 230334
Montreal
Quebec
H2X 2V1
Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 230478
Québec
Quebec
G1V 4X7
Canada
Universitaetsklinikum Erlangen /ID# 229433
Erlangen
Bavaria
91054
Germany
Universitaetsklinikum Frankfurt /ID# 229431
Frankfurt am Main
Hesse
60590
Germany
Universitaetsklinikum Muenster /ID# 229432
Munster
Lower Saxony
48149
Germany
DermaKiel Allergie und Haut Centrum /ID# 229630
Kiel
Schleswig-Holstein
24148
Germany
Fachklinik Bad Bentheim /ID# 231504
Bad Bentheim
48455
Germany
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022
Rzeszów
Podkarpackie Voivodeship
35-055
Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053
Gdansk
Pomeranian Voivodeship
80-546
Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971
Elblag
Warmian-Masurian Voivodeship
82-300
Poland
Dermed Centrum Medyczne Sp. z o.o /ID# 229051
Lodz
Łódź Voivodeship
90-265
Poland
FG002
Period B: APR/APR, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
FG003
Period B: APR/RZB, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
FG004
Period B: APR/APR, R
Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (responders [R]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
FG005
Period B: APR/RZB, R
Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (R) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
FG000234 subjects
FG001118 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000216 subjects
FG001118 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00018 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0009 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other, Not Specified
FG0006 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Period B (Week 16 to Week 52)
Type
Comment
Milestone Data
STARTED
Participants re-randomized in Period B
FG0000 subjects
FG001118 subjects
FG00278 subjects
FG00383 subjects
FG00422 subjects
FG00520 subjects
Received ≥ 1 Dose of Study Drug
FG0000 subjects
FG001116 subjects
FG00275 subjects
FG00382 subjects
FG004
Received RZB as Rescue Medication
FG0000 subjects
FG0010 subjects
FG00247 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG00169 subjects
FG00242 subjects
FG00357 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00149 subjects
FG00236 subjects
FG00326 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0016 subjects
FG0024 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Period A: APR
Apremilast 30 mg orally BID up to Week 16
BG001
Period A: RZB
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000234
BG001118
BG002352
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00046.2± 14.27
BG00145.5± 13.63
BG00246.0± 14.04
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00079
BG00142
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00023
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
ITT_A Population: all participants randomized in Period A
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Period A: APR
Apremilast 30 mg orally BID up to Week 16
OG001
Period A: RZB
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4
Units
Counts
Participants
OG000234
OG001118
Title
Denominators
Categories
Title
Measurements
OG0005.1(2.3 to 8.0)
OG00155.9(47.0 to 64.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
< 0.001
Adjusted for strata (baseline body weight [≤ 100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥ 1]) for the comparison of 2 treatment groups.
Adjusted Difference
50.7
2-Sided
95
41.3
60.1
Superiority
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).
ITT_A Population: all participants randomized in Period A.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Period A: APR
Apremilast 30 mg orally BID up to Week 16
OG001
Period A: RZB
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4.
Units
Counts
Participants
OG000
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.
ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Period B: APR/APR, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
OG001
Period B: APR/RZB, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
Units
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.
ITT_A Population: all participants randomized in Period A
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Period A: APR
Apremilast 30 mg orally BID up to Week 16
OG001
Period A: RZB
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4.
Units
Counts
Participants
OG000
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.
ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Period B: APR/APR, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
OG001
Period B: APR/RZB, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
Units
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).
ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Period B: APR/APR, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
OG001
Period B: APR/RZB, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
Units
Counts
Participants
Time Frame
All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Description
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Period A: APR
Apremilast 30 mg orally BID up to Week 16
0
234
4
234
101
234
EG001
Period A: RZB
Risankizumab 150 mg as a single SC injection at Day 1 and Week 4
0
118
1
118
24
118
EG002
Period B: RZB/RZB
Participants who received risankizumab 150 mg as a single subcutaneous (SC) injection at Day 1 and continued on risankizumab at Weeks 16, 28, and 40
0
116
8
116
36
116
EG003
Period B: APR/APR
Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID up to Week 52.
0
97
2
97
27
97
EG004
Period B: APR/RZB
Participants who received apremilast in Period A who were re-randomized to receive risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, 44.
0
102
3
102
31
102
EG005
Period B: APR/APR/RZB
Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID and received rescue medication with risankizumab.
0
48
0
48
15
48
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG0030 events0 affected97 at risk
EG0040 events0 affected102 at risk
EG0050 events0 affected48 at risk
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
OBSTRUCTIVE PANCREATITIS
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0021 events1 affected116 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0021 events1 affected116 at risk
EG003
UMBILICAL HERNIA
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0021 events1 affected116 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
APPENDICITIS PERFORATED
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0021 events1 affected116 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
LOWER LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0021 events1 affected116 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0021 events1 affected116 at risk
EG003
OSTEOCHONDROSIS
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
PROSTATE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
CAROTID ARTERY STENOSIS
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
GENERALISED TONIC-CLONIC SEIZURE
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0021 events1 affected116 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0021 events1 affected116 at risk
EG003
NASAL INFLAMMATION
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0011 events1 affected118 at risk
EG0020 events0 affected116 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0022 events2 affected116 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected234 at risk
EG0010 events0 affected118 at risk
EG0020 events0 affected116 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
DIARRHOEA
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG00050 events47 affected234 at risk
EG0011 events1 affected118 at risk
EG0020 events0 affected116 at risk
EG0031 events1 affected97 at risk
EG0041 events1 affected102 at risk
EG0050 events0 affected48 at risk
NAUSEA
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG00045 events41 affected234 at risk
EG0010 events0 affected118 at risk
EG0022 events2 affected116 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG00016 events16 affected234 at risk
EG00113 events13 affected118 at risk
EG00220 events19 affected116 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG00013 events10 affected234 at risk
EG0015 events4 affected118 at risk
EG00214 events11 affected116 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected234 at risk
EG0013 events3 affected118 at risk
EG0025 events5 affected116 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG00028 events27 affected234 at risk
EG0013 events3 affected118 at risk
EG0021 events1 affected116 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected234 at risk
EG0012 events2 affected118 at risk
EG0026 events6 affected116 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Adjusted for strata (baseline body weight [≤ 100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥ 1]) for the comparison of 2 treatment groups.
Adjusted Difference
56.8
2-Sided
95
47.7
66.0
Superiority
Counts
Participants
OG00078
OG00183
Title
Denominators
Categories
Title
Measurements
OG0002.6(0.0 to 6.1)
OG00172.3(62.7 to 81.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-squared
< 0.001
Difference
69.7
2-Sided
95
59.5
80.0
Superiority
234
OG001118
Title
Denominators
Categories
Title
Measurements
OG00018.8(13.8 to 23.8)
OG00184.7(78.3 to 91.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
< 0.001
Adjusted for strata (baseline body weight [≤ 100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥ 1] for the comparison of 2 treatment groups.