A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Phase 2/3 – combined trial
Conditions:
Crohn's Disease
Sponsor: Janssen Research & Development, LLC
trial.available_in:
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Overview
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
Description
This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.
Who can participate
Inclusion Criteria:
* Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
* Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
* Have screening laboratory test results within the protocol specified parameters
* A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion Criteria:
* Current diagnosis of ulcerative colitis or indeterminate colitis
* Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
* Unstable doses of concomitant Crohn's disease therapy
* Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
* Any medical contraindications preventing study participation
Locations
39
Australia (1)
The Queen Elizabeth Hospital
Adelaide
Belarus (1)
Grodno University Hospital
Grodno
Bosnia and Herzegovina (1)
University Clinical Centre of the Republic of Srpska
Banja Luka
Brazil (1)
MK Blumenau Pesquisa Clínica
Blumenau
Canada (1)
University of Calgary
Calgary , Alberta
China (1)
Peking University First Hospital
Beijing
Colombia (1)
Medplus Medicina Prepagada S.A.
Bogotá
Croatia (1)
Opca bolnica Bjelovar
Bjelovar
Czech Republic (1)
Nemocnice Ceske Budejovice
České Budějovice
France (1)
CHU Amiens
Amiens
Georgia (1)
TSMU The First University Clinic
Tbilisi
Germany (1)
Klinikum Augsburg
Augsburg
Greece (1)
Laiko General Hospital of Athens
Athens
Hungary (1)
Réthy Pál Kórház - Rendelőintézet
Békéscsaba
India (1)
Apex Hospitals Ltd
Jaipur
Israel (1)
Ha'Emek Medical Center
Afula
Italy (1)
Policlinico S.Orsola Malpighi, AOU di Bologna
Bologna
Japan (1)
Asahikawa City Hospital
Asahikawa
Jordan (1)
Khalidi Hospital and Medical Center
Amman
Latvia (1)
Pauls Stradins Clinical University Hospital
Riga
Lebanon (1)
Ain Wazein Hospital
Ain Wazein
Lithuania (1)
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas
Malaysia (1)
Hospital Ampang
Ampang
Netherlands (1)
Amsterdam UMC locatie VUMC
Amsterdam
New Zealand (1)
Auckland City Hospital
Auckland
North Macedonia (1)
General City Hospital 8mi Septemvri
Skopje
Poland (1)
NZOZ Centrum Medyczne KERmed
Bydgoszcz
Puerto Rico (1)
San Juan Bautista School of Medicine
Caguas
Russia (1)
Kazan State Medical University
Kazan'
Saudi Arabia (1)
King Abdullah Medical City in Holy Capital
Mecca
Serbia (1)
Special hospital for Internal diseases, Oncomed system
Belgrade
Slovakia (1)
FNsP F.D.R. Banska Bystrica
Banská Bystrica
South Korea (1)
Korea University Ansan Hospital
Ansan-si
Spain (1)
Hosp Reina Sofia
Córdoba
Taiwan (1)
Chang-Hua Christian Hospital
Changhua
Tunisia (1)
Hopital Regional Mohamed Tahar El Maamouri
Nabeul
Ukraine (1)
MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council
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