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Trial details
A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
Current status:
Approved
|
Date registered:
16/01/2019
Trial version(s)
History: 24/10/2018
History: 24/10/2018
Current: 24/10/2018
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Main Information
Primary registry identifying number
LBCTR2019010167
Protocol number
CNTO1959CRD3001
MOH registration number
2018/2/52806
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
20/12/2018
Primary sponsor
Janssen Research & Development, LLC
Primary sponsor: Country of origin
USA
Public title
A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
Acronym
GALAXI
Scientific title
A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
Acronym
GALAXI
Brief summary of the study: English
The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn’s disease.
Brief summary of the study: Arabic
الغرض من هذا البرنامج هو تقييم فاعلية وأمان غوزيلكوماب عند استخدامه لدى مشاركين مصابين بداء كرون نشط من متوسط إلى حاد
Health conditions/problem studied: Specify
Moderately to Severely Active Crohn's Disease
Interventions: Specify
Arm Title * Type * Description [*] Phase 2 (GALAXI 1): Group 1 (Guselkumab) Experimental Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab. Phase 2 (GALAXI 1): Group 2 (Guselkumab) Experimental Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab. Phase 2 (GALAXI 1): Group 3 (Guselkumab) Experimental Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab. Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Active Comparator Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Experimental Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab. Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Experimental Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab. Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab) Active Comparator Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab. Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab) Experimental Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcaneous (SC) injection. Participants who are eligible and willing to continue Intervention Name* Type* Associated Arms Description Guselkumab Dose 1 Drug Phase 2 (GALAXI 1): Group 1 (Guselkumab) Guselkumab will be administered by IV infusion. Guselkumab Dose 2 Drug Phase 2 (GALAXI 1): Group 1 (Guselkumab) Phase 2 (GAL AXI 1): Group 2 (Guselkumab) Guselkumab will be administered by SC injection. Guselkumab Dose 3 Drug Phase 2 (GALAXI 1): Group 2 (Guselkumab) Guselkumab will be administered by IV infusion. Guselkumab Dose 4 Drug Phase 2 (GALAXI 1): Group 3 (Guselkumab) Guselkumab will be administered by IV infusion. Guselkumab Dose 5 Drug Phase 2 (GALAXI 1): Group 3 (Guselkumab) Guselkumab will be by SC injection. Guselkumab Drug Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection. Ustekinumab Drug Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Placebo Drug Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV
Key inclusion and exclusion criteria: Inclusion criteria
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
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
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 (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 8 weeks prior to baseline (or within 5 half-lives of baseline, whichever is longer) - Prior exposure to p40 inhibitors or p19 inhibitors - Any medical contraindications preventing study participation
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Active
Study phase
2 to 3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Guselkumab
Type of IMP
Immunological
Pharmaceutical class
interleukin inhibitor
Therapeutic indication
Crohn's disease
Therapeutic benefit
Change in the Crohn's Disease Activity Index (CDAI) Score
Biospecimen retention
Samples without DNA
Biospecimen description
Target sample size
28
Actual enrollment target size
Date of first enrollment: Type
Actual
Date of first enrollment: Date
31/03/2019
Date of study closure: Type
Actual
Date of study closure: Date
31/05/2024
Recruitment status
Recruiting
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
to be determined in case applicable
Additional data URL
https://clinicaltrials.gov/ct2/show/NCT03466411?term=CNTO1959CRD3001&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
Janssen Research & Development, LLC
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Aziz
Zoghbi
Beirut
Lebanon
01--612500 ext2040
zog_Az@mct-cro.com
MCT s.a.r.l (CRO)
Scientific
Jansen
US
United States of America
844-434-4210
JNJ.CT@sylogent.com
Janssen (Sponsor)
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
American University of Beirut
Dr. Ala Sharara
Gastroenterology
Approved
Hotel Dieu De France
Dr. Cesar Yaghi
Gastroenterology
Approved
Mount Lebanon Hospital
Dr. Mona Hallak
Gastroenterology
Approved
Rafik Hariri University Hospital
Dr. Iyad issa
Gastroenterology
Approved
Bellevue Medical Center
Dr. Bilal hotayt
Gastroenterology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Mount Lebanon Hospital
16/07/2018
Marie Merheb
marie.merheb@mlh.com.lb
05/957000 extension: 1200
Hotel Dieu de France
03/07/2018
virginia khoury
virginia.elkhoury@usj.edu.lb
01-421 229
Rafic Hariri University Hospital
19/06/2018
Rawan yamout
Rawan.Yamout@crurhuh.com
01-832036
Bellevue Medical Center
29/06/2018
Alain Zogheib
alainzo@hotmail.com
01-421000 ext 2335
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Crohn's Disease
2-Propanol (T51.2)
Crohn's Disease
Interventions
Intervention
Description
Keyword
Guselkumab Dose 1
Guselkumab will be administered by IV infusion.
Phase 2 (GALAXI 1): Group 1 (Guselkumab)
Guselkumab Dose 2
Guselkumab will be administered by SC injection.
Phase 2 (GALAXI 1): Group 1 (Guselkumab) Phase 2 (GAL AXI 1): Group 2 (Guselkumab)
Guselkumab Dose 3
Guselkumab will be administered by IV infusion.
Phase 2 (GALAXI 1): Group 2 (Guselkumab)
Guselkumab Dose 4
Guselkumab will be administered by IV infusion.
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Guselkumab Dose 5
Guselkumab will be by SC injection.
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Guselkumab
Guselkumab will be administered by IV infusion and SC injection.
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.
Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
Placebo
Placebo will be administered as IV infusion.
Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
Primary Outcomes
Name
Time points
Measure
The CDAI score will be assessed by collecting information on 8 different Crohn’s disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity.
Baseline and Week 12
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Clinical remission is defined as CDAI less than (<) 150 points.
Week 12
Phase 3: Clinical Remission at Week 12
Key Secondary Outcomes
Name
Time points
Measure
Clinical remission is defined as CDAI score <150.
Week 12
Phase 2: Clinical Remission at Week 12
Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score <150.
Week 12
Phase 2: Clinical Response at Week 12
PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.
Week 12
Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12
Clinical-biomarker response is defined using clinical response based on the CDAI score and reduction from baseline in C-reactive protein (CRP) or fecal calprotectin.
Week 12
Phase 2: Clinical-Biomarker Response at Week 12
Endoscopic Response is measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD is based on the evaluation of 4 endoscopic components across 5 ileocolonic segments, with a total score ranging from 0 to 56.
Week 12
Phase 2 and Phase 3: Endoscopic Response at Week 12
Clinical remission is defined as CDAI score <150.
Week 48
Phase 3: Clinical Remission at Week 48
Durable clinical remission is defined as CDAI<150 for most of all visits between Week 12 and Week 48.
Week 48
Phase 3: Durable Clinical Remission at Week 48
Corticosteroid-free clinical remission is defined as CDAI score <150 at Week 48 and not receiving corticosteroids at Week 48.
Week 48
Phase 3: Corticosteroid-Free Clinical Remission at Week 48
PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.
Week 48
Phase 3: PRO-2 Remission at Week 48
Fatigue response will be based on the Patient-Reported Outcomes Measurement Information System (PROMIS).Fatigue Short Form 7a contains 7 items that evaluate the severity of fatigue, with higher scores indicating greater fatigue.
Week 12
Phase 3: Fatigue Response at Week 12
Endoscopic response is measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Week 48
Phase 3: Endoscopic Response at Week 48
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial