Clinical trial NCT05347095: A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Official title: A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Fistulizing Crohns Disease
Perianal Crohns Disease
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 280
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 to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.


Eligibility criteria: Inclusion Criteria:

* Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
* Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
* Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)

Exclusion Criteria:

* Has a very severe luminal disease activity
* History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
* Any medical contraindications preventing study participation
* Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease

Primary outcomes:
measure: Percentage of Participants who Achieve Combined Fistula Remission at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants who Achieve Combined Fistula Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants who Achieve Clinically Assessed Fistula Remission
timeFrame: Week 24
measure: Percentage of Participants who Achieve Radiological Fistula Remission Based on Radiological Findings Assessed by MRI
timeFrame: Week 24
measure: Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12
timeFrame: Week 12
measure: Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48
timeFrame: Baseline up to Week 48
measure: Percentage of Participants who Achieve Clinical Remission (CDAI less than [<] 150) by Visit Over Time Through Week 48 Among Participants with CDAI Greater than (>) 150 at Baseline
timeFrame: Through Week 48
measure: Percentage of Participants who Achieve a Clinical Response by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline
timeFrame: Through Week 48
measure: Percentage of Participants who Achieve Steroid-free Clinical Remission by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline
timeFrame: Through Week 48
measure: Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response Among Participants With CDAI >220 at Baseline
timeFrame: Week 24 and Week 48
measure: Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline
timeFrame: Week 24 and Week 48
measure: Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline
timeFrame: Week 24 and Week 48
measure: Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response among Participants with CDAI >220 at Baseline
timeFrame: Week 24 and Week 48
measure: Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response at Week 24 and Week 48
timeFrame: Week 24 and Week 48
measure: Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission at Week 24 and Week 48
timeFrame: Week 24 and Week 48
measure: Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response at Week 24 and Week 48
timeFrame: Week 24 and Week 48
measure: Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission at Week 24 and Week 48
timeFrame: Week 24 and Week 48
measure: Change from Baseline in Perianal Disease Activity Index (PDAI) Overall Score, Discharge Score, and Pain Score by Visit Over Time Through Week 48
timeFrame: Baseline up to Week 48
measure: Percentage of Participants who Achieve Clinically Assessed Fistula Response by Visit Over Time Through Week 48
timeFrame: Through Week 48
measure: Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48
timeFrame: Through Week 48
measure: Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among the Participants who Achieve Clinical Fistula Remission at Week 24
timeFrame: Week 48
measure: Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24
timeFrame: Week 48
measure: Time to Clinical Fistula Remission
timeFrame: Up to Week 96
measure: Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48
timeFrame: Week 24 and Week 48
measure: Percentage of participants who Achieve Radiological Remission Based on Radiological Findings Assessed by MRI at Week 48
timeFrame: Week 48
measure: Percentage of Participants who Achieve Radiological Remission Assessed by MRI at Week 48 Among the Participants who Achieve Radiological Remission at Week 24
timeFrame: Week 48
measure: Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants who Achieve Combined Clinical and Radiological Fistula Remission at Week 24
timeFrame: Week 48
measure: Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants with Clinical Fistula Response at Week 24
timeFrame: Week 48
measure: Percentage of Participants with Proctitis at Week 48 Among Participants with MRI-confirmed Proctitis at Baseline
timeFrame: Week 48
measure: Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn's disease (MAGNIFI-CD) by Visit Over Time Through Week 48
timeFrame: Baseline up to Week 48
measure: Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48
timeFrame: Baseline up to Week 48
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48
timeFrame: Baseline; Up to Week 48
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48
timeFrame: Baseline; Up to Week 48
measure: Change from Baseline in Quality-of-life as Assessed by European Quality-of-Life Five Dimension Five Level Scale (EQ5D-5L) Score by Visit Over Time Through Week 48
timeFrame: Baseline up to Week 48
measure: Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48
timeFrame: Baseline; Through Week 48
measure: Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48
timeFrame: Baseline; Through Week 48
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 48 and Week 96
measure: Number of Participants with Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Week 48 and Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group Of Naples
state: Florida
city: Orlando
country: United States
facility: AdventHealth Medical Group Blood & Marrow Transplant at Orlando
state: Florida
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Adelaide
country: Australia
facility: Flinders Medical Centre
city: Fitzroy
country: Australia
facility: St Vincent's Hospital - Melbourne
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Newtown
country: Australia
facility: Royal Prince Alfred Hospital
city: North Terrace
country: Australia
facility: Royal Adelaide Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: South Brisbane
country: Australia
facility: Mater Hospital
city: Bruxelles
country: Belgium
facility: Hopital Erasme
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Edmonton
country: Canada
facility: University of Alberta- Ziedler Ledcor Centre
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a s
city: Praha 9
country: Czechia
facility: ISCARE a.s.
city: Alexandria
country: Egypt
facility: Alexandria University Hospital
city: Cairo
country: Egypt
facility: National Hepatology and Tropical Medicine Research Institute
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
city: Giza
country: Egypt
facility: Cairo university
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Pare
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Paris
country: France
facility: Hopital Saint Joseph
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy Brabois
city: Berlin
country: Germany
facility: Charite - Campus Mitte
city: Frankfurt
country: Germany
facility: JWG-University Hospital
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein Kiel
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Athens Attica
country: Greece
facility: Alexandra General Hospital of Athens
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Athens
country: Greece
facility: Hippokration Hospital
city: Athens
country: Greece
facility: Sotiria General State Hospital of Chest Diseases
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Larissa
country: Greece
facility: University Hospital Of Larissa
city: Patras
country: Greece
facility: Patras University Hospital
city: Thessaloniki
country: Greece
facility: Hippokration Hospital
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
city: Szeged
country: Hungary
facility: Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
city: Afula
country: Israel
facility: Haemek Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Negrar ( Ve)
country: Italy
facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: RHO
country: Italy
facility: Azienda Ospedaliera G.Salvini Ospedale di Rho
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Abiko
country: Japan
facility: KOKIKAI Tokatsu Tsujinaka Hospital
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Fukuoka-ken
country: Japan
facility: Kitakyushu Municipal Medical Center
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Hiroshima shi
country: Japan
facility: Hiroshima University Hospital
city: Hukuoka
country: Japan
facility: Hospital of the University of Occupational and Enviromental Health
city: Kagoshima
country: Japan
facility: Sameshima Hospital
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Kojunkai Daido Clinic
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Kinshukai Infusion Clinic
city: Sakai
country: Japan
facility: JOHAS Osaka Rosai Hospital
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Shinjuku-ku
country: Japan
facility: Tokyo Yamate Medical Center
city: Shizuoka
country: Japan
facility: Matsuda Hospital
city: Suita
country: Japan
facility: Osaka University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Toyota
country: Japan
facility: Ieda Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Yokkaichi
country: Japan
facility: Yokkaichi Hazu Medical Center
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizen's Hospital
city: Amman
country: Jordan
facility: The Speciality Hospital (TSH) / Advanced Clinical Center
city: Amman
country: Jordan
facility: Jordan University Hospital
city: Amman
country: Jordan
facility: Abdali Hospital
city: Irbid
country: Jordan
facility: Irbid Specialty Hospital
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit van Amsterdam
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Bialystok
country: Poland
facility: Gastromed Kralisz Romatowski Stachurska Sp. j.
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lodz
country: Poland
facility: Centrum Medyczne Med Gastr
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Torun
country: Poland
facility: GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Wroclaw
country: Poland
facility: Melita Medical Sp. z o.o.
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Braga
country: Portugal
facility: Uls Braga - Hosp. Braga
city: Lisboa
country: Portugal
facility: Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
city: Porto
country: Portugal
facility: H. Santo António - Centro Hospitalar do Porto
city: Dammam
country: Saudi Arabia
facility: King Fahad Specialist hospital
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City
city: Riyadh
country: Saudi Arabia
facility: King Saud University Medical City
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Ferrol
country: Spain
facility: Hosp. Arquitecto Marcide
city: Girona
country: Spain
facility: Hosp. Univ. Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Majadahonda
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hosp. Univ. Miguel Servet
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Kozyatagi Hospital
city: İzmir
country: Turkey
facility: Ege University Medical Faculty
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty Hospital
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: London North West University Healthcare NHS Trust
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospital NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: