Clinical trial NCT04936308: Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
Official title: A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

Detailed description: PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Guselkumab is a fully human monoclonal antibody (mAb) that binds to p19 protein subunit of interleukin (IL)-23 and blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. The primary hypothesis of this study is that guselkumab is superior to placebo as assessed by the proportion of participants who had an inadequate response (IR) and/or intolerance to one prior anti-tumor necrosis factor (anti-TNF) achieving an American College of Rheumatology 20 (ACR 20) response at Week 24. This study will consist of a screening phase (up to 6 weeks), blinded treatment phase (approximately up to 2 years), which includes a placebo-controlled period from Week 0 to Week 24, and an active-controlled treatment phase from Week 24 to Week 100, and safety follow-up phase (Week 112). Safety assessments will include physical examinations, vital signs, height, weight, electrocardiograms, and clinical safety laboratory assessments. The total duration of the study will be up to 118 weeks.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of active psoriatic arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
* Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
* Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis, with at least one psoriatic plaque of \>= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
* Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent

Exclusion Criteria:

* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
* Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars)
* Has ever received Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
* Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Primary outcomes:
measure: Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants who Achieve a Psoriasis Response of IGA Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 at Baseline
timeFrame: Week 24
measure: Percentage of Participants who Achieve PASI 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
timeFrame: Week 24
measure: Change From Baseline in HAQ-DI Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
timeFrame: Week 24
measure: Percentage of Participants who Achieve ACR 20 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants who Achieve ACR 50 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants who Achieve ACR 50 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants who Achieve ACR 70 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
timeFrame: Up to 112 weeks
measure: Percentage of Participants With AEs leading to Discontinuation of Study Intervention
timeFrame: Up to 112 weeks
measure: Percentage of Participants With Infections
timeFrame: Up to 112 weeks
measure: Percentage of Participants With Injection-site Reactions
timeFrame: Up to 100 weeks
measure: Percentage of Participants With Change from Baseline in Clinical Laboratory Abnormalities
timeFrame: Up to 112 weeks
measure: Percentage of participants With Laboratory Abnormalities With Maximum Toxicity Grades as per Common Terminology Criteria for Adverse Events (CTCAE) Toxicity
timeFrame: Up to 112 weeks
measure: Serum Guselkumab Concentration
timeFrame: Up to 112 weeks
measure: Percentage of Participants With Anti-guselkumab Antibodies
timeFrame: Up to 112 weeks
Other outcomes:
Locations:
city: Mountain Brook
country: United States
facility: Arthritis Associates
state: Alabama
city: Avondale
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Flagstaff
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Sun City
country: United States
facility: Arizona Arthritis and Rheumatology Associates
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Healthcare System
state: Arizona
city: Searcy
country: United States
facility: Unity Health-White County Medical Center
state: Arkansas
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: Thousand Oaks
country: United States
facility: Medvin Clinical Research
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research
state: California
city: Danbury
country: United States
facility: Clinical Research Center of Connecticut
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Ocoee
country: United States
facility: Advanced Clinical Research of Orlando
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology And Immunology Specialists
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Skokie
country: United States
facility: Clinic of Robert Hozman
state: Illinois
city: Monroe
country: United States
facility: The Arthritis and Diabetes Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Hagerstown
country: United States
facility: Klein And Associates M D P A
state: Maryland
city: Lansing
country: United States
facility: Great Lakes Center of Rheumatology
state: Michigan
city: Okemos
country: United States
facility: Arthritis and Rheumatology Center of MI
state: Michigan
city: Saint Clair Shores
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology P A
state: Minnesota
city: Saint Louis
country: United States
facility: Arthritis Consultants
state: Missouri
city: Voorhees
country: United States
facility: Arthritis Rheumatic And Back Disease Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
city: Las Cruces
country: United States
facility: Arthritis and Osteoperosis Associates of New Mexico
state: New Mexico
city: Orchard Park
country: United States
facility: Buffalo Rheumatology and Medicine PLLC
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Vandalia
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Rheumatology Associates of Oklahoma
state: Oklahoma
city: Memphis
country: United States
facility: Dr. Ramesh Gupta
state: Tennessee
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Corpus Christi
country: United States
facility: Adriana Pop Moody MD Clinic PA
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Fort Worth
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Lubbock
country: United States
facility: West Texas Clinical Research
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research LLC
state: Texas
city: Plano
country: United States
facility: Texas Rheumatology Care
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Waco
country: United States
facility: Arthritis And Osteoporosis Clinic
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest PLLC
state: Washington
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Cosultorios Reumatologógicos Pampa
city: Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
city: Buenos Aires
country: Argentina
facility: Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: OMI
city: Ciudad de Mendoza
country: Argentina
facility: Instituto de Reumatología Mendoza
city: San Miguel De Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: Hobart
country: Australia
facility: Southern Clinical Research
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Melbourne
country: Australia
facility: Skin Health Institute Inc.
city: Melbourne
country: Australia
facility: Eastern Health - Box Hill Hospital
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: Medical Center Unimed Plovdiv
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela
city: Ruse
country: Bulgaria
facility: Diagnosis-consulting centre-1
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: UMHAT St. Ivan Rilski
city: Sofia
country: Bulgaria
facility: ASIMP Rheumatology Centre St Irina EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital Sofiamed Sofia
city: Sofia
country: Bulgaria
facility: Medical Centre Synexus
city: Breclav
country: Czechia
facility: RHEUMA s r o
city: Hlucin
country: Czechia
facility: L K N Arthrocentrum
city: Ostrava
country: Czechia
facility: MUDr Rosypalova s r o
city: Pardubice
country: Czechia
facility: Arthrohelp S.R.O.
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: Medical Plus S R O
city: Zlin
country: Czechia
facility: PV Medical S R O
city: Budapest
country: Hungary
facility: Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: Uno Medical Trials Ltd.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
city: Szekesfehervar
country: Hungary
facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
city: Veszprem
country: Hungary
facility: Vital Medical Center Orvosi es Fogaszati Kozpont
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Hifa
country: Israel
facility: Carmel Medical Center
city: Kfar-Sava
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Bytom
country: Poland
facility: Nzoz Bif Med
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Krakow
country: Poland
facility: Malopolskie Badania Kliniczne Sp z o o
city: Krakow
country: Poland
facility: Malopolskie Centrum Kliniczne
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp z o o
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK MED S C
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Poznan
country: Poland
facility: Twoja Przychodnia PCM
city: Poznan
country: Poland
facility: Centrum Medyczne
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Warsaw
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Warszawa
country: Poland
facility: Rheuma Medicus Sp z o o
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park
city: Wroclaw
country: Poland
facility: WroMedica I Bielicka A Strzalkowska s c
city: San Juan
country: Puerto Rico
facility: GCM Medical Group
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
city: Barnaul
country: Russian Federation
facility: Altay Medical State University
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinck Regional Clinical Hospital
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Dermatovenerological Dispensary
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical University
city: Kemerovo
country: Russian Federation
facility: LLL Medical Center Revma-Med
city: Korolev
country: Russian Federation
facility: LLC Family Outpatient Clinic # 4
city: Krasnodar
country: Russian Federation
facility: Krasnodar Clinical Dermatovenerologic Dispensary
city: Krasnoyarsk
country: Russian Federation
facility: Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
city: Moscow
country: Russian Federation
facility: Clinical-Diagnostic Center Euromedservice, JSC
city: Moscow
country: Russian Federation
facility: FGBU Research Institute of Rheumatology named V.A.Nasonova
city: Moscow
country: Russian Federation
facility: GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
city: Orenburg
country: Russian Federation
facility: GBOU VPO Orenburg State Medical University
city: Rostov
country: Russian Federation
facility: Rostov Regional Clinical Dermatovenerological Dispensary
city: Saratov
country: Russian Federation
facility: Saratov Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: Smolensk regional hospital on Smolensk railway station
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg GBUZ Clinical Reumatological Hospital 25
city: St. Petersburg
country: Russian Federation
facility: X7 Clinical Research Company Limited
city: Tolyatti
country: Russian Federation
facility: GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Dermatovenerological Dispensary
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital - G.G. Kuvatov
city: Barakaldo
country: Spain
facility: Hosp. Univ. de Cruces
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Madrid
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Malaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias
city: Sevilla
country: Spain
facility: Hosp. Quiron Sagrado Corazon
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Adana
country: Turkey
facility: Adana City Hospital
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty
city: Eskisehir
country: Turkey
facility: Osmangazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar sehir Hastanesi
city: Istanbul
country: Turkey
facility: Marmara University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Cherkasy
country: Ukraine
facility: Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
city: Kharkiv
country: Ukraine
facility: Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
city: Khmelnytsky
country: Ukraine
facility: Khmelnitckiy regional hospital
city: Kryvyi Rih
country: Ukraine
facility: City Clinical Hospital No. 2
city: Kyiv
country: Ukraine
facility: Medical Center LLC 'Harmony of Beauty'
city: Kyiv
country: Ukraine
facility: Medical Center of 'Institute of Rheumatology', LLC
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
city: Kyiv
country: Ukraine
facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Medical Center 'Consylium Medical'
city: Lutsk
country: Ukraine
facility: Volyn Regional Clinical Hospital
city: Odessa
country: Ukraine
facility: LLC Medical House
city: Poltava
country: Ukraine
facility: ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
city: Vinnytsya
country: Ukraine
facility: Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
city: Zaporizhzhya
country: Ukraine
facility: Medical Center LLC 'Modern Clinic'
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: