Toggle navigation
Lebanon Clinical Trials Registry
Home
About Us
FAQs
Contact Us
Search Trials
Register
Log in
User Guide
Trial details
You are here
Home
Search Trials
Trial details
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:
29/02/2024
Trial version(s)
History: 24/10/2018
History: 24/10/2018
Current: 24/10/2018
Click here to view the tips and fields' descriptions
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
Phase 2 Dose-Ranging Study (GALAXI 1) All participants in the Phase 2 study will be randomized to 1 of 5 treatment groups as described below. Participants will remain on their assigned treatment regimens through the end of the 48-week study, unless otherwise specified. Group 1: Guselkumab Regimen 1 (1200 mg IV q4w x 3 → 200 mg SC q4w) Participants will receive guselkumab 1200 mg intravenous (IV) induction every 4 weeks (q4w) from Week 0 through Week 8 (ie, total of 3 IV doses). At Week 12, participants will continue treatment with guselkumab 200 mg subcutaneous (SC) maintenance q4w through Week 44. Group 2: Guselkumab Regimen 2 (600 mg IV q4w x 3 → 200 mg SC q4w) Participants will receive guselkumab 600 mg IV induction q4w from Week 0 through Week 8 (ie, total of 3 IV doses). At Week 12, participants will continue treatment with guselkumab 200 mg SC maintenance q4w through Week 44. Group 3: Guselkumab Regimen 3 (200 mg IV q4w x 3 → 100 mg SC q8w) Participants will receive guselkumab 200 mg IV induction q4w from Week 0 through Week 8 (ie, total of 3 IV doses). At Week 16, participants continue treatment with guselkumab 100 mg SC maintenance every 8 weeks (q8w) through Week 40. Group 4: Active Control, Ustekinumab (~6 mg/kg IV → 90 mg SC q8w) Participants will receive a single ustekinumab IV induction dose at Week 0 (weight-based IV doses approximating 6 mg/kg as outlined below). At Week 8, participants will receive ustekinumab SC maintenance (90 mg SC q8w) through Week 40. - Ustekinumab 260 mg (weight ≤55 kg) - Ustekinumab 390 mg (weight >55 kg and ≤85 kg) - Ustekinumab 520 mg (weight >85 kg) Group 5: Placebo → Placebo or Ustekinumab Crossover Participants will receive placebo IV q4w from Week 0 through Week 8 (ie, total of 3 IV doses). At Week 12, participants will continue treatment based on their clinical response status as follows: - Placebo responders: Continue placebo treatment q4w from Week 12 through Week 44. - Placebo nonresponders: Receive a single ustekinumab IV induction dose at Week 12 (weight-based IV doses approximating 6 mg/kg as outlined above). At Week 20, participants will receive ustekinumab SC maintenance (90 mg SC q8w) through Week 44. Phase 3 Dose-Confirming Studies (GALAXI 2 and GALAXI 3) Based on the Phase 2 data, 2 guselkumab dose regimens (ie, IV induction → SC maintenance) were selected for confirmatory evaluation in Phase 3. Identical dose regimens are to be evaluated in both Phase 3 studies. Group 1: Guselkumab Regimen 1 (200 mg IV q4w x 3 → 200 mg SC q4w) Participants will receive guselkumab 200 mg IV induction q4w from Week 0 through Week 8 (ie, total of3 IV doses). At Week 12, participants will continue treatment with guselkumab 200 mg SC maintenanceq4w through Week 44. Group 2: Guselkumab Regimen 2 (200 mg IV q4w x 3 → 100 mg SC q8w) Participants will receive guselkumab 200 mg IV induction q4w from Week 0 through Week 8 (ie, total of3 IV doses). At Week 16, participants will continue treatment with guselkumab 100 mg SC maintenanceq8w through Week 40. Group 3: Active Control – Ustekinumab (~6 mg/kg IV → 90 mg SC q8w) (Same as in GALAXI 1 above) Group 4: Placebo → Placebo or Ustekinumab Crossover (Same as in GALAXI 1 above)
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: • ≥18 years of age at screening • CD or fistulizing CD of ≥ 3 months duration (defined as ≥ 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy • Clinically active CD, defined as a baseline CDAI score ≥220 but ≤450 and either: mean daily SF count >3 or mean daily AP score > 1 • Endoscopic evidence of active ileocolonic CD as assessed by central endoscopy reading at the screening endoscopy, defined as a screening SES-CD score ≥ 6 (or ≥ 4 for participants with isolated ileal disease), based on the presence of ulceration in ≥ 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: – A minimum score of 1 for the component of “size of ulcers” and – A minimum score of 1 for the component of “ulcerated surface” • At least 1 of the following: – Current treatment with oral corticosteroids and/or immunomodulators (AZA, 6-MP, MTX) or – History of failure to respond to or tolerate oral corticosteroids or immunomodulators (AZA, 6-MP, MTX) or – History of corticosteroid dependence or – Prior primary nonresponse, secondary nonresponse, or intolerance to 1 or more biologic agent with at least the minimum dose approved for the treatment of CD (ie, infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) – A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
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: - Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might confound ability to assess the effect of treatment - Current or suspected abscess, unless adequately treated ≥ 3 weeks before baseline - Any kind of bowel resection within 6 months, or any other intra-abdominal or other major surgery within 12 weeks before baseline - Draining (ie, functioning) stoma or ostomy - Positive for an enteric pathogen, including Clostridioides difficile toxin in the previous 4 months - Any of the following prescribed medications or therapies within the specified period: – IV corticosteroids within 3 weeks of baseline – Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks of baseline – 6-thioguanine within 4 weeks of baseline – Biologic agents: anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol, adalimumab, golimumab) within 8 weeks of baseline; vedolizumab within 12 weeks of baseline; ustekinumab within 16 weeks of baseline; other immunomodulatory biologic agents, including approved and investigational biologic agents, within 12 weeks of baseline or within 5 half-lives of baseline, whichever is longer – Any investigational intervention within 4 weeks of baseline or within 5 half-lives of baseline, whichever is longer – Nonautologous stem cell therapy (eg, Prochymal), natalizumab, efalizumab, or biologic agents that deplete B- or T-cells (eg, rituximab, alemtuzumab, or visilizumab) received within 12 months of baseline – Treatment with apheresis (eg, Adacolumn apheresis) or total parenteral nutrition for Crohn’s disease within 3 weeks of baseline - Has previously received a biologic agent targeting IL-12/23 or IL-23, including but not limited to briakinumab, brazikumab, guselkumab, mirikizumab (formerly LY3074828), and risankizumab
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
No genetic research will be done on the samples, unless specific consent is provided by signing the Optional Genetic Research ICF. The results of tests done on the samples are only for scientific research. The video from the endoscopies will be destroyed after a period of about 15 years from the time of study closure. Some or all of the samples may also be kept and used for up to 15 years. The sponsor will ensure that samples are kept secure.
Target sample size
28
Actual enrollment target size
19
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
13/07/2027
Recruitment status
Complete
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
Janssen Research & Development,
LLC
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. Abdullah Al Omary
Gastroenterology
Approved
Bellevue Medical Center
Dr. Bilal hotayt
Gastroenterology
Approved
Saint George Hospital University Medical Center
Dr. Khalil Bedran
Gastroenterology
Approved
Nini Hospital
Dr. Mahmoud Osman
Gastroenterology
Approved
Ain Wazein Medical Village
Dr. Farid Kerbaj
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
Amani Mehtar
amani.mehtar@crurhuh.com
01-843834
Bellevue Medical Center
29/06/2018
Wediane Saoud
wediane.saoud@bmc.com.lb
01-682666 ext 7806
Saint George Hospital University Medical Center
12/04/2022
Sandra Berbari
smberbari@stgeorgehospital.org
01-441000 Ext: 1630
Nini Hospital
04/04/2022
Kamleh Ibrahim
kamleh.ibrahim@hopitalnini.com
06-431400, Ext: 3578
Ain w Zein Medical Village
25/03/2022
Itaf Al Ashkar
itaf.alashkar@gmail.com
05-509001 ext. 2018
Countries of Recruitment
Name
Lebanon
Australia
Austria
Belarus
Belgium
Bosnia and Herzegovina
Brazil
Canada
China
Colombia
Croatia
Czech Republic
France
Georgia
Germany
Hungary
India
Italy
Japan
Jordan
Republic of Korea
Latvia
Lithuania
The Former Yugoslav Rep of Macedonia
Malaysia
Netherlands
New Zealand
Poland
Portugal
Russian Federation
Saudi Arabia
Republic of Serbia
Slovakia
Spain
Taiwan
Tunisia
Turkey
Ukraine
United Kingdom
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Crohn's Disease
Crohn s disease, unspecified (K50.9)
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