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KEEPsAKE 1: A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03675308
Collaborator
(none)
964
Enrollment
256
Locations
2
Arms
65.3
Anticipated Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).

Condition or Disease Intervention/Treatment Phase
  • Biological: Placebo
  • Biological: Risankizumab
 Phase 3

Detailed Description

The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group treatment period. Period 2 is the long-term treatment period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 208), all participants are to receive open-label risankizumab 150 mg every 12 weeks. Participants will remain blinded to the original randomization allocation for the duration of the study. The total study duration is 228 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.

Study Design

Study Type:
Interventional
Actual Enrollment :
964 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)
Actual Study Start Date :
Mar 25, 2019
Actual Primary Completion Date :
Oct 8, 2020
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 208.

Biological: Placebo
Placebo for risankizumab administered by subcutaneous injection

Biological: Risankizumab
Risankizumab administered by subcutaneous injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI

    		•
    Experimental: Risankizumab

    Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 208.

    Biological: Risankizumab
    Risankizumab administered by subcutaneous injection
    Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 [Baseline and Week 24]

      Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

    Secondary Outcome Measures

    1. Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24 [Baseline and Week 24]

      The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

    2. Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24 [Baseline and Week 24]

      PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score.

    3. Percentage of Participants With an ACR20 Response at Week 16 [Baseline and Week 16]

      Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

    4. Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 [Week 24]

      A participant was classified as achieving MDA if 5 of the following 7 criteria were met: Tender joint count (out of 68 joints) ≤ 1 Swollen joint count (out of 66 joints) ≤ 1 PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3% Patient's assessment of pain ≤ 15 (VAS from 0 to 100) Patient's Global Assessment of disease activity ≤ 20 (VAS from 0 to 100) HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3) Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, for an overall score range from 0 to 6)

    5. Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24 [Baseline and Week 24]

      The investigator assessed each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail), pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (> 50 pits present), and nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling) and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. The mNAPSI score is calculated as the sum of all the components for all of the participant's fingernails giving a range of possible scores from 0 (absence of nail psoriasis) to 130 (the most severe nail psoriasis). A negative change from Baseline indicates improvement.

    6. Change From Baseline in Fingernail-Physician Global Assessment (PGA-F) [Baseline and Week 24]

      The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms associated with fingernail psoriasis. Participant's fingernails were assessed separately for nail bed signs and nail matrix signs of disease on a scale from 0 (clear) to 4 (severe). A participant's overall global score is the worse of the nail bed score and nail matrix score. For example, if a participant had a nail bed score '2' and a nail matrix score of '4,' this participant's overall score was '4.' A negative change from Baseline indicates improvement.

    7. Percentage of Participants With Resolution of Enthesitis at Week 24 [Week 24]

      Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0. LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst). To increase the sample size due to the smaller number of participants with enthesitis at Baseline, the pre-specified analysis of the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).

    8. Percentage of Participants With Resolution of Dactylitis at Week 24 [Week 24]

      Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0. LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used. Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. To increase sample size due to the smaller number of participants with dactylitis at Baseline, the pre-specified analysis of the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).

    9. Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24 [Baseline and Week 24]

      The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers. Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst). Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst). Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN. The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst).

    10. Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 [Baseline and Week 24]

      The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement.

    11. Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 [Baseline and Week 24]

      The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.

    12. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24 [Baseline and Week 24]

      Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

    13. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24 [Baseline and Week 24]

      Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.

    • Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts)

    • Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.

    • Participant has demonstrated an inadequate response or intolerance to or contraindication for conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

    • Presence of either at Screening:

    • ≥ 1 erosion on radiograph as determined by central imaging review or;

    • High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.

    Exclusion Criteria:

    • Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.

    • Participant has a known hypersensitivity to risankizumab.

    • Participant has previous treatment with biologic agent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pinnacle Research Group /ID# 167955 Anniston Alabama United States 36207
    2 Sun Valley Arthritis Center Ltd. /ID# 200270 Peoria Arizona United States 85381
    3 AZ Arthritis and Rheumotology Research, PLLC /ID# 209873 Phoenix Arizona United States 85032-9306
    4 Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875 Tucson Arizona United States 85704
    5 Southern Arizona VA Health Care System /ID# 209247 Tucson Arizona United States 85723
    6 Arthritis and Rheumatism Associates /ID# 209882 Jonesboro Arkansas United States 72401-6251
    7 Valerius Medical Group & Research Center /ID# 207428 Los Alamitos California United States 90720-5402
    8 Rheumatology Center of San Diego /ID# 201642 San Diego California United States 92128-2549
    9 Inland Rheum Clin Trials Inc. /ID# 201641 Upland California United States 91786
    10 Medvin Clinical Research /ID# 211127 Whittier California United States 90606
    11 New England Research Associates, LLC /ID# 207237 Bridgeport Connecticut United States 06606-1827
    12 Danbury Clinical Research, LLC /ID# 209517 Danbury Connecticut United States 06810
    13 Arthritis & Osteoporosis Center /ID# 207236 Hamden Connecticut United States 06518
    14 Arthritis & Rheumatic Disease Specialties /ID# 210802 Aventura Florida United States 33180
    15 Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099 Boca Raton Florida United States 33486
    16 SIMED Health, LLC /ID# 207461 Gainesville Florida United States 32607-2817
    17 Sweet Hope Research Specialty Inc /ID# 209393 Hialeah Florida United States 33016-1897
    18 Jacksonville Center for Clinical Research /ID# 209876 Jacksonville Florida United States 32216
    19 Rheum Assoc of Central FL /ID# 201622 Orlando Florida United States 32806
    20 HMD Research LLC /ID# 208427 Orlando Florida United States 32819
    21 IRIS Research and Development, LLC /ID# 208955 Plantation Florida United States 33324
    22 ForCare Clinical Research /ID# 168034 Tampa Florida United States 33613-1244
    23 Arthritis and Rheumatology /ID# 168046 Atlanta Georgia United States 30342
    24 Affinity Clinical Research /ID# 210816 Oak Brook Illinois United States 60523-1245
    25 OrthoIllinois /ID# 205300 Rockford Illinois United States 61114-4937
    26 Springfield Clinic /ID# 200244 Springfield Illinois United States 62702-3749
    27 Klein and Associates MD /ID# 169483 Hagerstown Maryland United States 21740
    28 The Center for Rheumatology and Bone Research /ID# 168017 Wheaton Maryland United States 20902
    29 Clinical Pharmacology Study Gr /ID# 168019 Worcester Massachusetts United States 01605
    30 Advanced Rheumatology, PC /ID# 168042 Lansing Michigan United States 48910
    31 June DO, PC /ID# 208915 Lansing Michigan United States 48910
    32 St. Paul Rheumatology /ID# 208471 Eagan Minnesota United States 55121
    33 Logan Health Research /ID# 213707 Kalispell Montana United States 59901
    34 Physician Research Collaboration, LLC /ID# 208670 Lincoln Nebraska United States 68516
    35 Center for Rheumatology LLP /ID# 207313 Albany New York United States 12203-3710
    36 NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310 Brooklyn New York United States 11201
    37 Joint & Muscle Research Instit /ID# 208620 Charlotte North Carolina United States 28204
    38 Medication Management, LLC /ID# 211734 Greensboro North Carolina United States 27408
    39 Coastal Carolina Health Care /ID# 208619 New Bern North Carolina United States 28562
    40 Velocity Clinical Research /ID# 200452 Blue Ash Ohio United States 45242-3763
    41 Marietta Memorial Hospital /ID# 210179 Marietta Ohio United States 45750-1635
    42 Paramount Medical Research Con /ID# 201583 Middleburg Heights Ohio United States 44130
    43 STAT Research, Inc. /ID# 213805 Springboro Ohio United States 45066
    44 Health Research of Oklahoma /ID# 168027 Oklahoma City Oklahoma United States 73103-2400
    45 Altoona Ctr Clinical Res /ID# 168037 Duncansville Pennsylvania United States 16635
    46 Allegheny Health Network Research Institute /ID# 210349 Pittsburgh Pennsylvania United States 15212-4756
    47 Clinical Research Ctr Reading /ID# 168070 Wyomissing Pennsylvania United States 19610
    48 Nashville Arthritis and Rheumatology /ID# 168069 Nashville Tennessee United States 37203
    49 Amarillo Ctr for Clin Research /ID# 208347 Amarillo Texas United States 79124
    50 Precision Comprehensive Clinical Research Solutions /ID# 208386 Colleyville Texas United States 76034
    51 Dallas VA Medical Center /ID# 208389 Dallas Texas United States 75216
    52 Precision Comprehensive Clinical Research Solutions /ID# 210597 Fort Worth Texas United States 76107
    53 Advanced Rheumatology of Houston /ID# 208354 The Woodlands Texas United States 77382
    54 DM Clinical Research /ID# 208351 Tomball Texas United States 77375
    55 Kadlec Clinic Rheumatology /ID# 207969 Kennewick Washington United States 99336
    56 Rheumatology and Pulmonary Clinic /ID# 200446 Beckley West Virginia United States 25801
    57 Aurora Rheumatology and Immunotherapy Center /ID# 168066 Franklin Wisconsin United States 53132
    58 Holy Family Memorial, Inc. /ID# 209387 Manitowoc Wisconsin United States 54220
    59 Gundersen Clinic, Ltd /ID# 209459 Onalaska Wisconsin United States 54650
    60 Framingham Centro Medico /ID# 210409 La Plata Buenos Aires Argentina 1902
    61 Hospital General de Agudos J. M. Ramos Mejia /ID# 169164 Buenos Aires Ciuadad Autonoma De Buenos Aires Argentina 1221
    62 Hospital Italiano de Buenos Aires /ID# 208474 Ciudad Autonoma Buenos Aires Ciuadad Autonoma De Buenos Aires Argentina 1199
    63 DOM Centro de Reumatologia /ID# 208479 Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires Argentina 1111
    64 Fundacion CIDEA /ID# 210494 Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires Argentina 1121
    65 Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 211622 Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires Argentina 1426
    66 Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169163 Rosario Santa Fe Argentina 2000
    67 Instituto CAICI /ID# 169168 Rosario Santa Fe Argentina 2000
    68 Centro Medico Privado de Reumatologia /ID# 208343 San Miguel de Tucuman Tucuman Argentina 4000
    69 Duplicate_Inst de Rehab Psicofisica /ID# 214681 Buenos Aires Argentina 2201
    70 Duplicate_Hospital Privado Univesitario /ID# 211623 Cordoba Argentina 5016
    71 Cimer /Id# 169167 San Miguel de Tucuman Argentina 4000
    72 The Canberra Hospital /ID# 207592 Garran Australian Capital Territory Australia 2605
    73 Royal Brisbane and Women's Hospital /ID# 212785 Herston Queensland Australia 4029
    74 Rheumatology Research Unit Sunshine Coast /ID# 207200 Maroochydore Queensland Australia 4558
    75 Griffith University /ID# 207505 Southport Queensland Australia 4222
    76 Flinders Medical Centre /ID# 210562 Bedford, Park South Australia Australia 5042
    77 Emeritus Research /ID# 207202 Camberwell Victoria Australia 3124
    78 Monash Medical Centre /ID# 208034 Clayton Victoria Australia 3168
    79 Duplicate_UZ Ghent /ID# 210036 Ghent Oost-Vlaanderen Belgium 9000
    80 ReumaClinic /ID# 208213 Genk Belgium 3600
    81 ZNA - Jan Palfijn /ID# 208212 Merksem Belgium 2170
    82 University Clinical Centre of the Republic of Srpska /ID# 208268 Banja Luka Republika Srpska Bosnia and Herzegovina 78000
    83 University Clinical Centre of the Republic of Srpska /ID# 208269 Banja Luka Republika Srpska Bosnia and Herzegovina 78000
    84 University Clinical Centre of the Republic of Srpska /ID# 210047 Banja Luka Republika Srpska Bosnia and Herzegovina 78000
    85 Clinical Center University of Sarajevo /ID# 208272 Sarajevo Bosnia and Herzegovina 71000
    86 SER - Serviços Especializados em Reumatologia /ID# 207489 Salvador Bahia Brazil 40150-150
    87 CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 207496 Juiz de Fora Minas Gerais Brazil 36010-570
    88 EDUMED Educacao em Saude S/S L /ID# 207488 Curitiba Parana Brazil 80440-080
    89 LMK Sevicos Medicos S/S /ID# 207491 Porto Alegre Rio Grande Do Sul Brazil 90480-000
    90 CPCLIN - Centro de Pesquisas Clínicas /ID# 207493 Sao Paulo Brazil 01228-200
    91 Medical center Medconsult /ID# 211399 Pleven Bulgaria 5800
    92 Medical center Excelsior /ID# 167741 Sofia Bulgaria 1407
    93 Diagnostic consultative center 17 Sofia /ID# 210506 Sofia Bulgaria 1505
    94 Military Medical Academy Multiprofile Hospital /ID# 210829 Sofia Bulgaria 1606
    95 Percuro Clinical Research, Ltd /ID# 169601 Victoria British Columbia Canada V8V 3M9
    96 Manitoba Clinic /ID# 206819 Winnipeg Manitoba Canada R3A 1M3
    97 CIADS Research Co Ltd /ID# 169600 Winnipeg Manitoba Canada R3N 0K6
    98 SKIN Centre for Dermatology /ID# 169604 Peterborough Ontario Canada K9J 5K2
    99 K. Papp Clinical Research /ID# 169603 Waterloo Ontario Canada N2J 1C4
    100 Groupe de Recherche en Maladies Osseuses Inc /ID# 169598 Sainte-foy Quebec Canada G1V 3M7
    101 Dr. Latha Naik /ID# 212188 Saskatoon Saskatchewan Canada S7K 3H3
    102 CTR Estudios Clinicos /ID# 208166 Providencia Chile 7500571
    103 Centro Internacional de Estudios Clinicos /ID# 209908 Santiago Chile 8420383
    104 Clinica Dermacross S.A /ID# 208163 Vitacura Santiago Chile 7640881
    105 Poliklinika Repromed /ID# 208628 Zagreb Grad Zagreb Croatia 10000
    106 Poliklinika Solmed /ID# 210965 Zagreb Grad Zagreb Croatia 10000
    107 UHC Osijek /ID# 208623 Osijek Osjecko-baranjska Zupanija Croatia 31000
    108 Klinicki bolnicki centar Rijeka /ID# 208621 Rijeka Primorsko-goranska Zupanija Croatia 51000
    109 Klinicki bolnicki centar Split /ID# 208626 Split Splitsko-dalmatinska Zupanija Croatia 21000
    110 Medical Center Kuna-Peric /ID# 208047 Zagreb Croatia 10000
    111 Poliklinika Bonifarm /ID# 208750 Zagreb Croatia 10000
    112 Revmacentrum MUDr. Mostera, s.r.o. /ID# 209025 Brno Czechia 615 00
    113 PV MEDICAL Services s.r.o. /ID# 210222 Praha Czechia 130 00
    114 MUDr. Zuzana Stejfova - revmatologicka ambulance /ID# 209027 Praha Czechia 140 00
    115 Affidea Praha s.r.o. /ID# 210223 Praha Czechia 148 00
    116 MEDICAL PLUS, s.r.o. /ID# 210439 Uherske Hradiste Czechia 686 01
    117 Bispebjerg and Frederiksberg Hospital /ID# 207576 Frederiksberg Hovedstaden Denmark 2000
    118 Aarhus University Hospital /ID# 168761 Aarhus C Midtjylland Denmark 8000
    119 North Estonia Medical Centre /ID# 208325 Mustamäe Linnaosa Harjumaa Estonia 13419
    120 Innomedica /ID# 211416 Tallinn Harjumaa Estonia 10117
    121 MediTrials /ID# 207816 Tartu Tartumaa Estonia 50708
    122 Helsinki University Hospital /ID# 207724 Helsinki Uusimaa Finland 00290
    123 Ite Pihlajanlinna Kuopio /ID# 208322 Kuopio Finland 70100
    124 Turku University Hospital /ID# 207726 Turku Finland 20520
    125 Rheumazentrum Ruhrgebiet /ID# 207216 Herne Nordrhein-Westfalen Germany 44649
    126 Immanuel Krankenhaus Berlin /ID# 207218 Berlin-buch Germany 13125
    127 Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209483 Frankfurt Germany 60590
    128 MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209484 Hamburg Germany 20095
    129 General Hospital Asklepieio Voulas /ID# 212956 Athens Attiki Greece 16673
    130 University General Hospital of Heraklion PA.G.N.I /ID# 206839 Heraklion Kriti Greece 71500
    131 424 General MILITARY Hospital /ID# 210974 Efkarpia (Thessalonikis) Thessaloniki Greece 56429
    132 Naval Hospital of Athens /ID# 206838 Athens Greece 11521
    133 Olympion General Clinic SA /ID# 207048 Patras Greece 26443
    134 Sheba Medical Center /ID# 207474 Ramat Gan Tel-Aviv Israel 5239424
    135 Barzilai Medical Center /ID# 207476 Ashkelon Israel 7830604
    136 Rambam Health Care Campus /ID# 208170 Haifa Israel 3109601
    137 Meir Medical Center /ID# 207473 Kfar Saba Israel 4428164
    138 Rabin Medical Center /ID# 207475 Petakh Tikva Israel 4941492
    139 Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799 Modena Emilia-Romagna Italy 41124
    140 Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207269 Ancona Italy 60126
    141 A.O.U. Policlinico G. Rodolico S.Marco - Presidio San Marco /ID# 207795 Catania Italy 95124
    142 Duplicate_Policlinico Univ Tor Vergata /ID# 207271 Rome Italy 00133
    143 Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207265 Verona Italy 37134
    144 Hanyang University Seoul Hospital /ID# 209263 Seoul Seoul Teugbyeolsi Korea, Republic of 04763
    145 Duplicate_Konkuk University Medical Ctr /ID# 207509 Seoul Seoul Teugbyeolsi Korea, Republic of 05030
    146 Kyungpook National Univ Hosp /ID# 207408 Daegu Korea, Republic of 41944
    147 M & M Centrs LTD /ID# 208733 Adazi Latvia LV-2164
    148 D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 207224 Liepaja Latvia LV-3401
    149 Pauls Stradins Clinical University Hospital /ID# 207220 Riga Latvia 1002
    150 Clinic ORTO /ID# 216218 Riga Latvia LV-1005
    151 Riga East Clinical University Hospital /ID# 207223 Riga Latvia LV-1079
    152 VAKK Dr. Kilda's Clinic /ID# 207330 Kaunas Lithuania 50128
    153 Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207331 Kaunas Lithuania 50161
    154 Klaipeda University Hospital /ID# 207329 Klaipeda Lithuania 92288
    155 Republican Siauliai hospital /ID# 207328 Siauliai Lithuania 76231
    156 Hospital Tuanku Jaafar /ID# 207919 Seremban Negeri Sembilan Malaysia 70300
    157 Hospital Raja Permaisuri Bainun /ID# 207920 Ipoh Perak Malaysia 30450
    158 Hospital Selayang /ID# 208938 Batu Caves Selangor Malaysia 68100
    159 University Malaya Med Ctr /ID# 208937 Kuala Lumpur Malaysia 59100
    160 CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 208331 Mexico City Ciudad De Mexico Mexico 11850
    161 Centro Integral en Reumatologia S.A de C.V /ID# 208346 Guadalajara Jalisco Mexico 44160
    162 Eukarya PharmaSite, SC /ID# 208431 Monterrey Nuevo Leon Mexico 64718
    163 Centro Peninsular de Investigación Clínica SCP /ID# 208345 Colonia Centro Yucatan Mexico 97000
    164 Hospital General Regional No. 1 Dr. Carlos Mac Gregor Sánchez Navarro /ID# 210835 Ciudad de Mexico Mexico 03100
    165 RM Pharma Specialists S.A de C.V /ID# 208330 Mexico City Mexico 03100
    166 Antonius Ziekenhuis /ID# 208587 Sneek Fryslan Netherlands 8601 ZK
    167 Universitair Medisch Centrum Groningen /ID# 208580 Groningen Netherlands 9713 GZ
    168 Medisch Centrum Leeuwarden /ID# 168453 Leeuwarden Netherlands 8934 AD
    169 Middlemore Clinical Trials /ID# 213256 Papatoetoe Auckland New Zealand 2025
    170 Waikato Hospital /ID# 213257 Hamilton Waikato New Zealand 3240
    171 CGM Research Trust /ID# 210498 Burwood New Zealand 8083
    172 Spolka Lekarzy INTERCOR /ID# 210191 Bydgoszcz Kujawsko-pomorskie Poland 85-605
    173 Nasz Lekarz Przychodnie Medyczne /ID# 216176 Torun Kujawsko-pomorskie Poland 87-100
    174 Malopolskie Centrum Kliniczne /ID# 208007 Krakow Malopolskie Poland 30-149
    175 McBk Sc /Id# 209132 Grodzisk Mazowiecki Mazowieckie Poland 05-825
    176 Centrum Medyczne Reuma Park w Warszawie /ID# 210352 Warsaw Mazowieckie Poland 02-691
    177 Osteo-Medic S.C. /ID# 208008 Bialystok Podlaskie Poland 15-351
    178 ClinicMed Daniluk, Nowak Sp.j. /ID# 210824 Bialystok Podlaskie Poland 15-879
    179 Centrum Kliniczno-Badawcze /ID# 208010 Elblag Warminsko-mazurskie Poland 82-300
    180 ETYKA-Osrodek Badan Klinicznych /ID# 216241 Olsztyn Warminsko-mazurskie Poland 10-117
    181 Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208145 Vila Nova De Gaia Porto Portugal 4434-502
    182 Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208147 Ponte de Lima Viana Do Castelo Portugal 4990-041
    183 Centro Hospitalar do Baixo Vouga /ID# 215979 Aveiro Portugal 3810-164
    184 CCA Braga - Hospital de Braga /ID# 208146 Braga Portugal 4710-243
    185 Instituto Português De Reumatologia /ID# 208149 Lisboa Portugal 1050-034
    186 Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208148 Lisboa Portugal 1649-035
    187 Mindful Medical Research /ID# 211129 San Juan Puerto Rico 00918-3756
    188 Cabinet Medical Dr Triff Carina /Id# 207528 Timisoara Timis Romania 300766
    189 Spitalul Clinic Sf. Maria /ID# 210054 Bucuresti Romania 011172
    190 Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 207340 Cluj-Napoca Romania 400006
    191 Spitalul Clinic de Recuperare Iasi /ID# 207371 Iasi Romania 700661
    192 LLC Family Outpatient Clinic № /ID# 169510 Korolev Moskva Russian Federation 141060
    193 Research Institute of Rheumatology named after V.A. Nasonova /ID# 207643 Moscow Moskva Russian Federation 115522
    194 LLC Medical Center /ID# 169516 Novosibirsk Novosibirskaya Oblast Russian Federation 630099
    195 Nort-Western State Medical University n.a. Mechnikov /ID# 207641 St. Petersburg Sankt-Peterburg Russian Federation 193015
    196 Kazan State Medical University /ID# 169511 Kazan Tatarstan, Respublika Russian Federation 420012
    197 Federal Center for Brain and Neurotechnology /ID# 207646 Moscow Russian Federation 117997
    198 Perm Regional Clinical Hospital /ID# 207642 Perm Russian Federation 614990
    199 Ulyanovsk Regional Clinical Hospital /ID# 169515 Ulyanovsk Russian Federation 432017
    200 Institute for Rheumatology /ID# 168194 Belgrade Beograd Serbia 11000
    201 Institute for Rheumatology /ID# 168197 Belgrade Beograd Serbia 11000
    202 Institute for Rheumatology /ID# 168198 Belgrade Beograd Serbia 11000
    203 Institute for Rheumatology /ID# 168199 Belgrade Beograd Serbia 11000
    204 Military Medical Academy /ID# 168218 Belgrade Beograd Serbia 11000
    205 Special Hospital for Rheuma /ID# 168255 Novi Sad Vojvodina Serbia 21000
    206 Special Hospital for Rheuma /ID# 210284 Novi Sad Vojvodina Serbia 21000
    207 National University Hospital /ID# 208599 Singapore Singapore 119074
    208 Singapore General Hospital /ID# 207917 Singapore Singapore 169608
    209 Changi General Hospital /ID# 208965 Singapore Singapore 529889
    210 REUMA-GLOBAL, s.r.o. /ID# 208017 Biely Kostol Slovakia 919 34
    211 MEDMAN s.r.o. /ID# 208018 Martin Slovakia 036 01
    212 Reum.hapi s.r.o. /ID# 208016 Nove Mesto nad Vahom Slovakia 915 01
    213 Thermium s.r.o. /ID# 208015 Piestany Slovakia 921 01
    214 REUMAMED POPRAD s.r.o. /ID# 208407 Poprad Slovakia 058 01
    215 Dr Jenny Potts /ID# 168691 Port Elizabeth Eastern Cape South Africa 6405
    216 University of Pretoria /ID# 167621 Pretoria Gauteng South Africa 0001
    217 Dr Elsa van Duuren /ID# 207577 Pretoria Gauteng South Africa 0002
    218 Arthritis Clinical Research Trials /ID# 167625 Cape Town Western Cape South Africa 7405
    219 Synexus Helderberg Clinical Research Centre /ID# 210891 Somerset West Western Cape South Africa 7130
    220 Winelands Medical Research Centre /ID# 167629 Stellenbosch Western Cape South Africa 7600
    221 Hospital Universitario Germans Trias i Pujol /ID# 208543 Badalona Barcelona Spain 08916
    222 Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207830 Sabadell Barcelona Spain 08208
    223 Hospital Universitario A Coruna - CHUAC /ID# 207826 A Coruna Spain 15006
    224 Hospital Universitario Torrecardenas /ID# 212716 Almeria Spain 04009
    225 Hospital Parc de Salut del Mar /ID# 209698 Barcelona Spain 08003
    226 Hospital Clinico Universitario San Carlos /ID# 207832 Madrid Spain 28040
    227 Hospital Universitario 12 de Octubre /ID# 207827 Madrid Spain 28041
    228 Hospital Universitario y Politecnico La Fe /ID# 207831 Valencia Spain 46026
    229 Orebro Universitetssjukhuset /ID# 207948 Orebro Orebro Lan Sweden 701 85
    230 Skane University hospital /ID# 210070 Malmo Skane Lan Sweden 214 28
    231 Falu Lasarett /ID# 210322 Falun Sweden 791 31
    232 Duplicate_Karolinska Univ Sjukhuset /ID# 208175 Solna Sweden 171 64
    233 Uppsala University Hospital /ID# 207944 Uppsala Sweden 75185
    234 Duplicate_Vastmanlands Sjukhus /ID# 207943 Vasteras Sweden 723 35
    235 Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 207567 Chia-Yi Taiwan 62247
    236 Chung Shan Medical University Hospital /ID# 207257 Taichung Taiwan 40201
    237 Linkou Chang Gung Memorial Ho /ID# 207255 Taoyuan City Taiwan 333
    238 State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 209556 Kharkiv Kharkivska Oblast Ukraine 61039
    239 Scientific Research Institute of Invalid Rehabilitation /ID# 207873 Vinnytsia Vinnytska Oblast Ukraine 21029
    240 CNE Cherkasy Regional Hospital of Cherkasy Regional Council /ID# 207912 Cherkasy Ukraine 18009
    241 MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 207730 Chernihiv Ukraine 14029
    242 PNE City Multifunctional Hospital No.18 /ID# 207911 Kharkiv Ukraine 61029
    243 Khmelnytskyi Regional Hospital /ID# 207753 Khmelnytskyi Ukraine 29000
    244 MI Kryvyi Rih City Clinical Hospital No.2 /ID# 207748 Kryvyi Rih Ukraine 50056
    245 Medical Center OK Clinic /ID# 207749 Kyiv Ukraine 02091
    246 Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 208276 Lutsk Ukraine 43005
    247 Lviv Municipal City Clinical Hospital #4 /ID# 207715 Lviv Ukraine 79011
    248 PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 207872 Poltava Ukraine 36011
    249 Public Institution 6th City Clinical Hospital /ID# 207754 Zaporizhzhia Ukraine 69035
    250 Duplicate_Barts Health NHS Trust /ID# 210534 London London, City Of United Kingdom E11 1NR
    251 NHS Greater Glasgow and Clyde /ID# 214942 Glasgow Scotland United Kingdom G12 0XH
    252 Midlands Partnership NHS Foundation Trust /ID# 214941 Stafford Staffordshire United Kingdom ST16 3SR
    253 Manchester University NHS Foundation Trust /ID# 207928 Manchester United Kingdom M13 9WL
    254 Portsmouth Hospitals University NHS Trust /ID# 207932 Portsmouth United Kingdom PO6 3LY
    255 Torbay and South Devon Nhs Foundation Trust /Id# 207931 Torquay United Kingdom TQ2 7AA
    256 Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210535 Wirral United Kingdom CH49 5PE

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03675308
    Other Study ID Numbers:
    • M16-011
    • 2017-002465-22
    First Posted:
    Sep 18, 2018
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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.:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Psoriatic

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at 186 sites in 38 countries globally. The study includes a 24-week double-blind placebo-controlled treatment period (Period 1) and an ongoing 184-week open-label treatment period (Period 2). Results are reported for Period 1 which was from 25 March 2019 to 8 October 2020.
    Pre-assignment Detail Participants were randomized equally (1:1 ratio) to receive double-blind treatment with risankizumab 150 mg or matched placebo for 24 weeks. Randomization was stratified by extent of psoriasis (≥ 3% body surface area [BSA] or < 3% BSA), current conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) use (0 vs ≥ 1), presence of dactylitis (yes vs no), and presence of enthesitis (yes vs no) at Baseline.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants randomized to receive placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Period Title: Overall Study
    STARTED 481 483
    COMPLETED 467 473
    NOT COMPLETED 14 10

    Baseline Characteristics

    Arm/Group Title Placebo Risankizumab Total
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Total of all reporting groups
    Overall Participants 481 483 964
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51.2
    (12.10)
    51.3
    (12.21)
    51.3
    (12.15)
    Age, Customized (Count of Participants)
    < 65 years
    408
    84.8%
    414
    85.7%
    822
    85.3%
    ≥ 65 years
    73
    15.2%
    69
    14.3%
    142
    14.7%
    Sex: Female, Male (Count of Participants)
    Female
    247
    51.4%
    231
    47.8%
    478
    49.6%
    Male
    234
    48.6%
    252
    52.2%
    486
    50.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    92
    19.1%
    93
    19.3%
    185
    19.2%
    Not Hispanic or Latino
    389
    80.9%
    390
    80.7%
    779
    80.8%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White
    451
    93.8%
    454
    94%
    905
    93.9%
    Black or African American
    2
    0.4%
    4
    0.8%
    6
    0.6%
    Asian
    22
    4.6%
    13
    2.7%
    35
    3.6%
    Native Hawaiian or Other Pacific Islander
    1
    0.2%
    3
    0.6%
    4
    0.4%
    American Indian or Alaska Native
    0
    0%
    1
    0.2%
    1
    0.1%
    Multiple
    5
    1%
    8
    1.7%
    13
    1.3%
    Current Use of csDMARD (Count of Participants)
    Yes
    364
    75.7%
    366
    75.8%
    730
    75.7%
    No
    117
    24.3%
    117
    24.2%
    234
    24.3%
    Extent of Psoriasis (Count of Participants)
    < 3% BSA
    209
    43.5%
    210
    43.5%
    419
    43.5%
    ≥ 3% BSA
    272
    56.5%
    273
    56.5%
    545
    56.5%
    Presence of Dactylitis (Count of Participants)
    Yes
    147
    30.6%
    148
    30.6%
    295
    30.6%
    No
    334
    69.4%
    335
    69.4%
    669
    69.4%
    Presence of Enthesitis (Count of Participants)
    Yes
    290
    60.3%
    297
    61.5%
    587
    60.9%
    No
    191
    39.7%
    186
    38.5%
    377
    39.1%
    Tender Joint Count (joints) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [joints]
    20.5
    (12.79)
    20.8
    (14.05)
    20.6
    (13.43)
    Swollen Joint Count (joints) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [joints]
    12.2
    (8.02)
    12.1
    (7.80)
    12.2
    (7.91)
    Patient's Assessment of Pain (mm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mm]
    57.1
    (22.61)
    57.1
    (22.57)
    57.1
    (22.58)
    Patient's Global Assessment of Disease Activity (mm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mm]
    57.4
    (22.06)
    57.9
    (21.75)
    57.6
    (21.89)
    Physician's Global Assessment of Disease Activity (mm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mm]
    62.4
    (16.99)
    61.3
    (17.64)
    61.8
    (17.32)
    Health Assessment Questionnaire Disability Index (HAQ-DI) (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    1.17
    (0.651)
    1.15
    (0.664)
    1.16
    (0.658)
    High-sensitivity C-reactive Protein (hsCRP) Level (mg/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/L]
    11.33
    (14.122)
    11.88
    (15.933)
    11.60
    (15.051)
    Psoriasis Area Severity Index (PASI) Score (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    10.04
    (10.436)
    10.89
    (10.052)
    10.47
    (10.244)
    Modified Nail Psoriasis Severity Index (mNAPSI) Score (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    16.56
    (16.045)
    18.13
    (16.443)
    17.31
    (16.243)
    Physician Global Assessment of Fingernail Psoriasis Score (PGA-F) (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    2.0
    (1.00)
    2.1
    (1.04)
    2.0
    (1.02)
    Short-Form 36 (SF-36) Physical Component Summary (PCS) Score (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    35.15
    (7.692)
    35.24
    (8.094)
    35.20
    (7.893)
    Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    29.3
    (11.23)
    29.4
    (11.28)
    29.4
    (11.25)

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
    Description Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set; Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 481 483
    Number (95% Confidence Interval) [percentage of participants]
    33.5
    7%
    57.3
    11.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of baseline psoriasis (≥ 3%/< 3% body surface area), presence of dactylitis (yes/no), presence of enthesitis (yes/no) and current csDMARD use (0/≥ 1).
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Cochran-Mantel-Haenszel
    Comments CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.
    Method of Estimation Estimation Parameter Response Rate Difference
    Estimated Value 24.0
    Confidence Interval (2-Sided) 95%
    18.0 to 30.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments Response Rate Difference = Risankizumab - Placebo
    2. Secondary Outcome
    Title Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
    Description The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis (PsA) use that could meaningfully impact efficacy assessment, was used.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 479 482
    Least Squares Mean (95% Confidence Interval) [score on a scale]
    -0.11
    -0.31
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Mixed Effect Model Repeated Measurement
    Comments MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.
    Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
    Estimated Value -0.20
    Confidence Interval (2-Sided) 95%
    -0.26 to -0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference = Risankizumab - Placebo
    3. Secondary Outcome
    Title Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
    Description PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score.
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 272 273
    Number (95% Confidence Interval) [percentage of participants]
    9.9
    2.1%
    52.3
    10.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Cochran-Mantel-Haenszel
    Comments CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.
    Method of Estimation Estimation Parameter Response Rate Difference
    Estimated Value 42.5
    Confidence Interval (2-Sided) 95%
    35.6 to 49.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments Response Rate Difference = Risankizumab - Placebo
    4. Secondary Outcome
    Title Percentage of Participants With an ACR20 Response at Week 16
    Description Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
    Time Frame Baseline and Week 16

    Outcome Measure Data

    Analysis Population Description
    Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 481 483
    Number (95% Confidence Interval) [percentage of participants]
    33.4
    6.9%
    56.3
    11.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Cochran-Mantel-Haenszel
    Comments CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.
    Method of Estimation Estimation Parameter Response Rate Difference
    Estimated Value 23.1
    Confidence Interval (2-Sided) 95%
    16.8 to 29.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Response Rate Difference = Risankizumab - Placebo
    5. Secondary Outcome
    Title Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
    Description A participant was classified as achieving MDA if 5 of the following 7 criteria were met: Tender joint count (out of 68 joints) ≤ 1 Swollen joint count (out of 66 joints) ≤ 1 PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3% Patient's assessment of pain ≤ 15 (VAS from 0 to 100) Patient's Global Assessment of disease activity ≤ 20 (VAS from 0 to 100) HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3) Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, for an overall score range from 0 to 6)
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 481 483
    Number (95% Confidence Interval) [percentage of participants]
    10.2
    2.1%
    25.0
    5.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Cochran-Mantel-Haenszel
    Comments CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.
    Method of Estimation Estimation Parameter Response Rate Difference
    Estimated Value 14.8
    Confidence Interval (2-Sided) 95%
    10.2 to 19.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Response Rate Difference = Risankizumab - Placebo
    6. Secondary Outcome
    Title Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24
    Description The investigator assessed each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail), pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (> 50 pits present), and nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling) and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. The mNAPSI score is calculated as the sum of all the components for all of the participant's fingernails giving a range of possible scores from 0 (absence of nail psoriasis) to 130 (the most severe nail psoriasis). A negative change from Baseline indicates improvement.
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with nail psoriasis at Baseline; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 338 309
    Least Squares Mean (95% Confidence Interval) [score on a scale]
    -5.57
    -9.76
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Mixed Effect Model Repeated Measurement
    Comments MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -4.19
    Confidence Interval (2-Sided) 95%
    -5.70 to -2.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference = Risankizumab - Placebo
    7. Secondary Outcome
    Title Change From Baseline in Fingernail-Physician Global Assessment (PGA-F)
    Description The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms associated with fingernail psoriasis. Participant's fingernails were assessed separately for nail bed signs and nail matrix signs of disease on a scale from 0 (clear) to 4 (severe). A participant's overall global score is the worse of the nail bed score and nail matrix score. For example, if a participant had a nail bed score '2' and a nail matrix score of '4,' this participant's overall score was '4.' A negative change from Baseline indicates improvement.
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with nail psoriasis at Baseline; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 338 309
    Least Squares Mean (95% Confidence Interval) [score on a scale]
    -0.4
    -0.8
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Mixed Effect Model Repeated Measurement
    Comments MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.6 to -0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference = Risankizumab - Placebo
    8. Secondary Outcome
    Title Percentage of Participants With Resolution of Enthesitis at Week 24
    Description Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0. LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst). To increase the sample size due to the smaller number of participants with enthesitis at Baseline, the pre-specified analysis of the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set participants with a Baseline LEI > 0; Includes pooled data from KEEPsAKE 1 (this study) and the companion study M15-998 (NCT03671148; KEEPsAKE2). Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 448 444
    Number (95% Confidence Interval) [percentage of participants]
    34.8
    7.2%
    48.4
    10%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments The pre-specified analysis for the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Cochran-Mantel-Haenszel
    Comments CMH test adjusted for the stratification factors of current csDMARD use and extent of psoriasis at Baseline and study.
    Method of Estimation Estimation Parameter Response Rate Difference
    Estimated Value 13.9
    Confidence Interval (2-Sided) 95%
    7.6 to 20.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Response Rate Difference = Risankizumab - Placebo
    9. Secondary Outcome
    Title Percentage of Participants With Resolution of Dactylitis at Week 24
    Description Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0. LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used. Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. To increase sample size due to the smaller number of participants with dactylitis at Baseline, the pre-specified analysis of the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set participants with a Baseline LDI > 0; Includes pooled data from KEEPsAKE 1 (this study) and the companion study M15-998 (NCT03671148; KEEPsAKE2). Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 204 188
    Number (95% Confidence Interval) [percentage of participants]
    51.0
    10.6%
    68.1
    14.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments The pre-specified analysis for the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method Cochran-Mantel-Haenszel
    Comments CMH test adjusted for the stratification factors of current csDMARD use, extent of psoriasis at Baseline, and study.
    Method of Estimation Estimation Parameter Response Rate Difference
    Estimated Value 16.9
    Confidence Interval (2-Sided) 95%
    7.5 to 26.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Response Rate Difference = Risankizumab - Placebo
    10. Secondary Outcome
    Title Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24
    Description The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers. Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst). Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst). Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN. The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst).
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or who were rescued prior to Week 24.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 457 458
    Least Squares Mean (95% Confidence Interval) [score on a scale]
    0.32
    0.23
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.496
    Comments All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).
    Method ANCOVA
    Comments ANCOVA model including treatment and the stratification factors and baseline value as covariates.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.09
    Confidence Interval (2-Sided) 95%
    -0.36 to 0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference = Risankizumab - Placebo
    11. Secondary Outcome
    Title Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
    Description The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement.
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 477 482
    Least Squares Mean (95% Confidence Interval) [score on a scale]
    3.20
    6.52
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.
    Method Mixed Effect Model Repeated Measurement
    Comments MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 3.32
    Confidence Interval (2-Sided) 95%
    2.42 to 4.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference = Risankizumab - Placebo
    12. Secondary Outcome
    Title Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
    Description The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis (PsA) use that could meaningfully impact efficacy assessment, was used.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 477 482
    Least Squares Mean (95% Confidence Interval) [score on a scale]
    3.9
    6.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.
    Method Mixed Effect Model Repeated Measurement
    Comments MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.6
    Confidence Interval (2-Sided) 95%
    1.5 to 3.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference = Risankizumab - Placebo
    13. Secondary Outcome
    Title Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
    Description Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 481 483
    Number (95% Confidence Interval) [percentage of participants]
    11.3
    2.3%
    33.4
    6.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.
    Method of Estimation Estimation Parameter Response Rate Difference
    Estimated Value 22.2
    Confidence Interval (2-Sided) 95%
    17.3 to 27.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Response Rate Difference = Risankizumab - Placebo
    14. Secondary Outcome
    Title Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
    Description Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
    Time Frame Baseline and Week 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    Measure Participants 481 483
    Number (95% Confidence Interval) [percentage of participants]
    4.7
    1%
    15.3
    3.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.
    Method of Estimation Estimation Parameter Response Rate Difference
    Estimated Value 10.5
    Confidence Interval (2-Sided) 95%
    6.9 to 14.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Response Rate Difference = Risankizumab - Placebo

    Adverse Events

    Time Frame From first dose of study drug to Week 24
    Adverse Event Reporting Description
    Arm/Group Title Placebo Risankizumab
    Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
    All Cause Mortality
    Placebo Risankizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/481 (0%) 1/483 (0.2%)
    Serious Adverse Events
    Placebo Risankizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 18/481 (3.7%) 12/483 (2.5%)
    Blood and lymphatic system disorders
    ANAEMIA 1/481 (0.2%) 1 0/483 (0%) 0
    BLOOD LOSS ANAEMIA 0/481 (0%) 0 1/483 (0.2%) 1
    IRON DEFICIENCY ANAEMIA 1/481 (0.2%) 1 0/483 (0%) 0
    Cardiac disorders
    ANGINA UNSTABLE 1/481 (0.2%) 1 0/483 (0%) 0
    Ear and labyrinth disorders
    VERTIGO 1/481 (0.2%) 1 0/483 (0%) 0
    Gastrointestinal disorders
    COLITIS 0/481 (0%) 0 1/483 (0.2%) 1
    DUODENAL ULCER 1/481 (0.2%) 1 0/483 (0%) 0
    INTESTINAL OBSTRUCTION 1/481 (0.2%) 1 0/483 (0%) 0
    SMALL INTESTINAL OBSTRUCTION 1/481 (0.2%) 1 0/483 (0%) 0
    Hepatobiliary disorders
    CHOLECYSTITIS 0/481 (0%) 0 1/483 (0.2%) 1
    CHOLELITHIASIS 0/481 (0%) 0 1/483 (0.2%) 1
    Infections and infestations
    APPENDICITIS PERFORATED 1/481 (0.2%) 1 0/483 (0%) 0
    CELLULITIS 1/481 (0.2%) 2 1/483 (0.2%) 1
    COMPLICATED APPENDICITIS 1/481 (0.2%) 1 0/483 (0%) 0
    DYSENTERY 1/481 (0.2%) 1 0/483 (0%) 0
    GASTROENTERITIS 0/481 (0%) 0 1/483 (0.2%) 1
    ORAL BACTERIAL INFECTION 1/481 (0.2%) 1 0/483 (0%) 0
    PNEUMONIA 2/481 (0.4%) 2 1/483 (0.2%) 1
    PNEUMONIA VIRAL 0/481 (0%) 0 1/483 (0.2%) 1
    UROSEPSIS 0/481 (0%) 0 1/483 (0.2%) 1
    VIRAL UPPER RESPIRATORY TRACT INFECTION 0/481 (0%) 0 1/483 (0.2%) 1
    Metabolism and nutrition disorders
    DEHYDRATION 0/481 (0%) 0 1/483 (0.2%) 1
    Musculoskeletal and connective tissue disorders
    ARTHRITIS 0/481 (0%) 0 1/483 (0.2%) 1
    INTERVERTEBRAL DISC PROTRUSION 1/481 (0.2%) 1 0/483 (0%) 0
    PSORIATIC ARTHROPATHY 1/481 (0.2%) 1 0/483 (0%) 0
    ROTATOR CUFF SYNDROME 1/481 (0.2%) 1 0/483 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BREAST CANCER 1/481 (0.2%) 1 0/483 (0%) 0
    NON-SMALL CELL LUNG CANCER 1/481 (0.2%) 1 0/483 (0%) 0
    Psychiatric disorders
    DEPRESSION 0/481 (0%) 0 1/483 (0.2%) 1
    Renal and urinary disorders
    URETEROCELE 0/481 (0%) 0 1/483 (0.2%) 1
    Respiratory, thoracic and mediastinal disorders
    PNEUMONIA ASPIRATION 0/481 (0%) 0 1/483 (0.2%) 1
    Skin and subcutaneous tissue disorders
    PSORIASIS 1/481 (0.2%) 1 0/483 (0%) 0
    PUSTULAR PSORIASIS 1/481 (0.2%) 1 0/483 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo Risankizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/481 (0%) 0/483 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization AbbVie
    Phone 800-633-9110
    Email abbvieclinicaltrials@abbvie.com
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03675308
    Other Study ID Numbers:
    • M16-011
    • 2017-002465-22
    First Posted:
    Sep 18, 2018
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022