A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Arthritis, Psoriatic Clinical Trial

— STAR  

Official title:

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929210
• Other study ID #: CR109043
• Secondary ID: 2021-000465-32CN
• Status: Recruiting
• Phase: Phase 4
• Start date: August 30, 2021
• Est. completion date: June 4, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.

Description:

PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: June 4, 2026
• Est. primary completion date: June 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
• Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
• Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints)
• Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
• Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis

Exclusion Criteria:

• Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
• Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
• Has previously received any biologic treatment
• Has ever received a 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Guselkumab
Guselkumab will be administered as subcutaneous injection.
• Placebo
Matching placebo will be administered as subcutaneous injection.

Locations

Country	Name	City	State
Argentina	Centro Privado de Medicina Familiar	Buenos Aires
Argentina	Cosultorios Reumatologógicos Pampa	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Hospital Italiano La Plata	La Plata
Australia	Emeritus Research	Camberwell
Australia	Southern Clinical Research	Hobart
Australia	Liverpool Hospital	Liverpool
Australia	Rheumatology Research Unit	Maroochydore
Australia	Eastern Health - Box Hill Hospital	Melbourne
Australia	Skin Health Institute Inc.	Melbourne
Bulgaria	Exacta Medica	Pleven
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	Medical Center Artmed	Plovdiv
Bulgaria	Medical Center Unimed Plovdiv	Plovdiv
Bulgaria	UMHAT Kaspela	Plovdiv
Bulgaria	UMHAT St. Ivan Rilski	Sfia
Bulgaria	ASIMP Rheumatology Centre St Irina EOOD	Sofia
Bulgaria	DCC Convex EOOD	Sofia
Bulgaria	Medical Centre Synexus	Sofia
Bulgaria	MHAT 'Lyulin' EAD	Sofia
Bulgaria	Military Medical Academy	Sofia
Bulgaria	University Multiprofile Hospital Sofiamed Sofia	Sofia
Bulgaria	DDC Sv. Ivan Rilski OOD	Targovishte
Canada	G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.	Quebec
Canada	Eastern Regional Health Authority, St. Clare's Mercy Hospital	St. John's	Newfoundland and Labrador
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Skin Care Centre	Vancouver	British Columbia
Czechia	Revmaclinic	Brno
Czechia	Revmatologie s r o	Brno
Czechia	Revmacentrum MUDr Mostera s r o	Brno Zidenice
Czechia	L K N Arthrocentrum	Hlucin
Czechia	MUDr Rosypalova s r o	Ostrava
Czechia	Arthrohelp S.R.O.	Pardubice
Czechia	Revmatologicky ustav	Praha
Czechia	Medical Plus S R O	Uherske Hradiste
Denmark	Frederiksberg Hospital	Frederiksberg
Denmark	Rigshospitalet Glostrup	Glostrup
Denmark	Køge Sygehus Region Sjaelland	Køge
Denmark	Vejle Sygehus	Vejle
Georgia	LTD Clinic LJ	Kutaisi
Georgia	Clinic on Mtskheta Street	T'bilisi
Georgia	LTD 'Aversi Clinic'	T'bilisi
Georgia	Ltd American Hospital Network	T'bilisi
Georgia	Tbilisi Heart and Vascular Clinic Ltd	T'bilisi
Georgia	Aleksandre Aladashvili Clinic LLC	Tbilisi
Georgia	Consilium Medulla-multiprofile clinic Ltd	Tbilisi
Georgia	LTD Helsicore	Tbilisi
Georgia	LTD MediClub Georgia	Tbilisi
Georgia	Ltd New Hospitals	Tbilisi
Georgia	LTD The First Medical Center	Tbilisi
Georgia	TSMU The First University Clinic	Tbilisi
Georgia	JSC Evex Hospitals	Tnilisi
Germany	ISA - Interdisciplinary Study Association GmbH	Berlin
Germany	Hamburger Rheuma Forschungszentrum II	Hamburg
Germany	Rheumazentrum Ruhrgebiet	Herne
Germany	Rheumazentrum Ratingen	Ratingen
Hong Kong	Prince Of Wales Hospital	Hong Kong
Hungary	Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft	Budapest
Hungary	Qualiclinic Kft	Budapest
Hungary	Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz	Gyula
Hungary	Kistarcsai Flor Ferenc Korhaz	Kistarcsa
Hungary	Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz	Székesfehérvár
Hungary	Vital Medical Center Orvosi es Fogaszati Kozpont	Veszprem
Israel	Bnai Zion Medical Center	Haifa
Israel	Carmel Medical Center	Hifa
Israel	Meir Medical Center	Kfar-Sava
Israel	Sheba Medical Center	Ramat Gan
Italy	A.O. Universitaria Ospedali Riuniti di Ancona	Ancona
Italy	Azienda Ospedaliero-Universitaria di Cagliari	Monserrato
Italy	Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia
Italy	Policlinico Tor Vergata	Roma
Italy	Humanitas Hospital	Rozzano (MI)
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Malaysia	Hospital Selayang	Batu Caves
Malaysia	Hospital Pulau Pinang	George Town
Malaysia	Hospital Sultan Ismail	Johor Bahru
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Tuanku Jaafar	Seremban
Philippines	Cebu Doctors' University Hospital	Cebu City
Philippines	Davao Doctors Hospital	Davao City
Philippines	Lipa Medix Medical Hospital	Lipa
Philippines	ManilaMed Medical Center Manila	Manila
Philippines	Ilocos Training and Regional Medical Center	San Fernando
Poland	ClinicMed Daniluk Nowak Spolka Komandytowa	Bialystok
Poland	Szpital Uniwersytecki nr 2 im dr Jana Biziela	Bydgoszcz
Poland	Nzoz Bif Med	Bytom
Poland	Ambulatorium sp. z o.o.	Elblag
Poland	Centrum Kliniczno Badawcze	Elblag
Poland	Centrum Medyczne Promed	Krakow
Poland	Malopolskie Badania Kliniczne Sp z o o	Krakow
Poland	Centrum Medyczne AMED oddzial w Lodzi	Lodz
Poland	Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna	Lodz
Poland	Dermed Centrum Medyczne Sp z o o	Lodz
Poland	KO-MED Centra Kliniczne LUBLIN	Lublin
Poland	Pro Life Medica Sp. z o.o.	Lublin
Poland	NZOZ Lecznica MAK MED S C	Nadarzyn
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sol
Poland	Reumedika s c Wieslawa Porawska Lukasz Porawski	Poznan
Poland	Twoja Przychodnia Poznanskie Centrum Medyczne	Poznan
Poland	Lubelskie Centrum Diagnostyczne	Swidnik
Poland	MICS Centrum Medyczne Torun	Torun
Poland	MICS Centrum Medyczne Warszawa	Warsaw
Poland	Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher	Warsaw
Poland	Centrum Medyczne AMED Targowek	Warszawa
Poland	Centrum Medyczne Reuma Park	Warszawa
Poland	ETG Warszawa	Warszawa
Poland	Rheuma-Medicus Sp. z o.o.	Warszawa
Poland	WroMedica I.Bielicka, A.Strzalkowska s.c.	Wroclaw
Portugal	Ccab - Hosp. de Braga	Braga
Portugal	Ulsg - Hosp. Sousa Martins	Guarda
Portugal	Chln - Hosp. Santa Maria	Lisboa
Portugal	Chlo - Hosp. Egas Moniz	Lisboa
Portugal	Hospital CUF Tejo	Lisboa
Portugal	Ipr Inst Port de Reumatologia	Lisboa
Portugal	Ulsam - Hosp. Conde de Bertiandos	Ponte de Lima
Portugal	Chsj - Hosp. Sao Joao	Porto
Russian Federation	Altay Medical State University	Barnaul
Russian Federation	Chelyabinck Regional Clinical Hospital	Chelyabinsk
Russian Federation	Chelyabinsk Regional Clinical Dermatovenerological Dispensary	Chelyabinsk
Russian Federation	Sverdlovsk Regional Clinical Hospital N. 1	Ekaterinbourg
Russian Federation	Regional Clinical Diagnostic Center of Udmurtia Region	Izhevsk
Russian Federation	LLL Medical Center Revma-Med	Kemerovo
Russian Federation	LLC Family Outpatient Clinic # 4	Korolev
Russian Federation	Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon	Krasnoyarsk
Russian Federation	Clinical-Diagnostic Center Euromedservice, JSC	Moscow
Russian Federation	FGBU Research Institute of Rheumatology named V.A.Nasonova	Moscow
Russian Federation	GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'	Moscow
Russian Federation	Llc Ultramed	Omsk
Russian Federation	GBOU VPO Orenburg State Medical University	Orenburg
Russian Federation	GBUZ Perm Regional Clinical Hospital	Perm
Russian Federation	Republican Hospital n.a.V.A.Baranov	Petrozavodsk
Russian Federation	Rostov Regional Clinical Dermatovenerological Dispensary	Rostov
Russian Federation	St. Petersburg GBUZ Clinical Reumatological Hospital 25	St. Petersburg
Russian Federation	X7 Clinical Research Company Limited	St. Petersburg
Russian Federation	GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'	Tolyatti
Russian Federation	Republican Clinical Hospital - G.G. Kuvatov	Ufa
Russian Federation	Clinical Hospital #3	Yaroslavl
Slovakia	Reumatologicka ambulancia	Martin
Slovakia	Reumatologicka ambulancia	Nove Mesto nad Vahom
Slovakia	Reumatologická ambulancia Thermium s.r.o.	Piestany
Slovakia	REUMAMED POPRAD, s.r.o.	Poprad
Slovakia	Reumex s.r.o	Rimavska Sobota
Spain	Hosp. Univ. A Coruna	A Coruna
Spain	Hosp. Univ. de Cruces	Barakaldo
Spain	Hosp Clinic de Barcelona	Barcelona
Spain	Hosp. Univ. de Basurto	Bilbao
Spain	Hosp Reina Sofia	Cordoba
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hosp. Regional Univ. de Malaga	Málaga
Spain	Corporacio Sanitari Parc Tauli	Sabadell
Spain	Clinica Gaias	Santiago de Compostela
Spain	Hosp. Quiron Sagrado Corazon	Sevilla
Spain	Hosp. Virgen Macarena	Sevilla
Spain	Hosp. Univ. I Politecni La Fe	Valencia
Sweden	Karolinska Universitetssjukhuset	Solna
Sweden	Akademiska Sjukhuset	Uppsala
Taiwan	National Taiwan University Hospital	Hsin Chu
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan
Thailand	Phramongkutklao Hospital and Medical College	Bangkok
Thailand	Ramathibodi Hospital Mahidol University	Bangkok
Thailand	Chiang Mai University	Chiangmai
Turkey	Adana City Hospital	Adana
Turkey	Ankara Bilkent City Hospital	Ankara
Turkey	Gulhane Training and Research Hospital	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Uludag University Medical Faculty	Bursa
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Marmara University Medical Faculty	Istanbul
Turkey	Necmettin Erbakan University Meram Medical Faculty	Konya
Ukraine	Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council	Cherkasy
Ukraine	Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital	Kharkiv
Ukraine	Khmelnitckiy regional hospital	Khmelnytsky
Ukraine	City Clinical Hospital No. 2	Kryvyi Rih
Ukraine	Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'	Kyiv
Ukraine	Medical Center of 'Institute of Rheumatology', LLC	Kyiv
Ukraine	SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine	Kyiv
Ukraine	Volyn Regional Clinical Hospital	Lutsk
Ukraine	Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council	Odessa
Ukraine	ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil	Poltava
Ukraine	Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'	Ternopil
Ukraine	Health Clinic Limited Liability Company	Vinnytsia
Ukraine	Medical Center LLC 'Modern Clinic'	Zaporizhzhya
United Kingdom	Royal Free London NHS Foundation Trust	Barnet
United Kingdom	St. Lukes Hospital	Bradford
United Kingdom	University Hospital Coventry & Warwickshire NHS Trust	Coventry
United Kingdom	Chapel Allerton Hospital	Leeds
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester
United Kingdom	North Tyneside General Hospital	Newcastle
United Kingdom	Haywood Hospital	Stoke on Trent
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	Austin Regional Clinic	Austin	Texas
United States	Bay Pines VA Healthcare System	Bay Pines	Florida
United States	Arizona Arthritis & Rheumatology Research, PLLC	Chandler	Arizona
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas
United States	Adriana Pop Moody MD Clinic PA	Corpus Christi	Texas
United States	Clinical Research Center of Connecticut	Danbury	Connecticut
United States	St. Paul Rhuematology P A	Eagan	Minnesota
United States	Klein And Associates M D P A	Hagerstown	Maryland
United States	RC Research	Hinsdale	Illinois
United States	UT Physicians Center for Autoimmunity	Houston	Texas
United States	Newport Huntington Medical Group	Huntington Beach	California
United States	West Texas Clinical Research	Lubbock	Texas
United States	Arizona Arthritis and Rheumatology Research PLLC	Mesa	Arizona
United States	Southwest Rheumatology Research LLC	Mesquite	Texas
United States	Arizona Arthritis and Rheumatology Research PLLC	Phoenix	Arizona
United States	Arizona Arthritis Research, PLC.	Phoenix	Arizona
United States	Integral Rheumatology And Immunology Specialists	Plantation	Florida
United States	OHSU Rheumatology Clinic, Marquam Hill	Portland	Oregon
United States	Epic Medical Research	Red Oak	Texas
United States	OrthoIllinois	Rockford	Illinois
United States	Clinical Research Institute of Michigan, LLC	Saint Clair Shores	Michigan
United States	Unity Health-White County Medical Center	Searcy	Arkansas
United States	Swedish Medical Center	Seattle	Washington
United States	Clinvest	Springfield	Missouri
United States	Arizona Arthritis and Rheumatology Associates	Sun City	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Southern Arizona VA Healthcare System	Tucson	Arizona
United States	STAT Research, Inc.	Vandalia	Ohio
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Canada,  Czechia,  Denmark,  Georgia,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Malaysia,  Philippines,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24	BASDAI is a self-assessment tool that consists of 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. First 5 items were scored on a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 equals to (=) none to 10=very severe. Quantitative morning stiffness was scored on a 10 cm VAS ranging from 0=0 hours to 10=2 or more hours. 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity.	Baseline and Week 24
Secondary	Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24	The ASDAS-CRP is a composite of 5 disease activity variables with only partial overlap. The 4 self-reported items included in this index are back pain (VAS), duration of morning stiffness, peripheral pain/swelling, and participant global assessment of disease activity; these are combined with the C-reactive protein (CRP) value. Selected cut-offs for improvement scores are: a change greater than or equal to (>=) 1.1 units for "clinically important improvement" and a change >= 2.0 units for "major improvement.	Baseline and Week 24
Secondary	Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24	DAPSA assessed the joint domain of psoriatic arthritis (PsA) and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram/deciliter [mg/dL], value less than [<] lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), participant assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.	Baseline and Week 24
Secondary	Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.	Baseline and Week 24
Secondary	Percentage of Participants with Investigator's Global Assessment (IGA) 0/1 Response at Week 24 among Participants with >= 3% Body Surface Area (BSA) Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline	Percentage of participants with IGA 0/1 response at week 24 among the participants with >= 3 percent (%) BSA psoriatic involvement and an IGA score of >= 2 (mild) at baseline will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given timepoint. Overall lesions are graded for induration, erythema, and scaling using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 24
Secondary	Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at Week 24	Change from baseline in SPARCC score for MRI SI joints at week 24 among the participants with a positive MRI of the sacroiliac joints at baseline will be reported. SPARCC method focuses on the cartilaginous portion of the SI joint, and scores presence (score of 1) versus absence (score of 0) of bone marrow edema in each SI joint quadrant.	Baseline and Week 24
Secondary	Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24	Percentage of participants who achieve a >= 50 % improvement from baseline in BASDAI score at week 24 will be reported.	Baseline and Week 24
Secondary	Percentage of Participants who Achieve ASDAS Clinically Important Improvement at Week 24	Percentage of participants who achieve ASDAS clinically important improvement at week 24 will be reported.	Week 24
Secondary	Percentage of Participants who Achieve Ankylosing Spondylitis Activity Score (ASAS) 40 Response at Week 24	Percentage of participants who achieve ASAS 40 response at Week 24 will be reported. ASAS 40 defined as improvement from baseline of >= 40% and with an absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Participant's global assessment (0 to 10 cm; 0=very well, 10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none, 10=very severe); no worsening at all from baseline in remaining domain.	Week 24
Secondary	Percentage of Participants who Achieve ASDAS Major Improvement at Week 24	Percentage of participants who achieve ASDAS major improvement at Week 24 will be reported.	Week 24
Secondary	Change from Baseline in SPARCC Score for MRI Spine at Week 24	Change from baseline in SPARCC score for MRI spine at week 24 among the participants with a positive MRI of the spine at baseline will be reported. The SPARCC scoring system for the spine scores the 6 discovertebral units considered by the reader as the most abnormal, and then separately assesses each quadrant of 3 adjacent sagittal slices, with additional points for "depth" and high "intensity" of the lesion.	Baseline and Week 24
Secondary	Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 60 weeks
Secondary	Number of Participants with Serious Adverse Events (SAEs)	A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.	Up to 60 weeks
Secondary	Number of Participants with Reasonably Related AEs	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 60 weeks
Secondary	Number of Participants with AEs Leading to Discontinuation of Study Intervention	Number of participants with AEs leading to discontinuation of study intervention will be reported.	Up to 60 weeks
Secondary	Number of Participants with Infections	Number of participants with infections will be reported.	Up to 60 weeks
Secondary	Number of participants with Injection-Site Reactions	Number of participants with injection-site reactions will be reported. A study intervention injection-site reaction is any adverse reaction at a subcutaneous study intervention injection-site.	Up to 60 weeks
Secondary	Number of Participants with Laboratory Abnormalities (Chemistry, Hematology) by Maximum Toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) Grades	Number of participants with laboratory abnormalities (chemistry, hematology) by maximum toxicity (CTCAE 5.0) grades will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.	Up to 60 weeks
Secondary	Serum Guselkumab Concentration Over Time	Serum guselkumab concentration over time will be reported.	Up to 60 weeks
Secondary	Number of Participants with Antibodies to Guselkumab	Number of participants with antibodies to guselkumab will be reported.	Up to 60 weeks