| CTRI Number |
CTRI/2019/06/019738 [Registered on: 18/06/2019] Trial Registered Prospectively |
| Last Modified On: |
01/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohns Disease. |
|
Scientific Title of Study
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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 Crohns Disease. |
| Trial Acronym |
GALAXI |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2017-002195-13 |
EudraCT |
| CNTO1959CRD3001, Amendment 5 dated 12 July 2022 |
Protocol Number |
| NCT03466411 |
ClinicalTrials.gov |
| NMRR-18-999-41391 |
Other |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Annappa Kamath |
| Designation |
Executive Director Project Leadership- BIOTECH CLIENT DELIVERY MANAGEMENT |
| Affiliation |
Parexel International Clinical Research Private Limited |
| Address |
Cowrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU, INDIA.
Bangalore
KARNATAKA
560103
India |
| Phone |
918067723000 |
| Fax |
918067723001 |
| Email |
Annappa.Kamath@parexel.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Annappa Kamath |
| Designation |
Executive Director Project Leadership- BIOTECH CLIENT DELIVERY MANAGEMENT |
| Affiliation |
Parexel International Clinical Research Private Limited |
| Address |
Cowrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU, INDIA.
Bangalore
KARNATAKA
560103
India |
| Phone |
918067723000 |
| Fax |
918067723001 |
| Email |
Annappa.Kamath@parexel.com |
|
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Source of Monetary or Material Support
|
| Janssen Research & Development, LLC
920 US Route 202 South, Raritan, New Jersey 08869, United States of America. |
|
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Primary Sponsor
|
| Name |
Janssen Research Development LLC |
| Address |
920 US Route 202 South, Raritan, New Jersey 08869, United States of America. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Parexel International Clinical Research Private Limited |
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World,
Ground Floor, Bay Area – Adjacent to Building 6A,
Outer Ring Road, Devarabeesanahalli Village,
BENGALURU – 560103, Karnataka, INDIA. |
|
Countries of Recruitment
Modification(s)
|
Australia
Austria
Belarus
Belgium
Bosnia and Herzegovina
Brazil
Canada
China
Colombia
Croatia
Czech Republic
France
Georgia
Germany
Greece
India
Italy
Japan
Jordan
Latvia
Lebanon
Lithuania
Malaysia
Netherlands
New Zealand
Poland
Portugal
Republic of Korea
Russian Federation
Saudi Arabia
Slovakia
Spain
Taiwan
Tunisia
Turkey
Ukraine
United Kingdom
United States of America
Israel
Serbia
Hungary
Macedonia |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Kedia |
All India Institute of Medical Sciences |
Gastroenterology and Human Nutrition Unit and 3rd floor, Ansari Nagar-110029
New Delhi
DELHI |
1126594397
dr.saurabhkedia@yahoo.com |
| Dr Kuldeep Singh |
Apex Hospitals Private Limited |
Clinical Research Department Academic block, 1st floor, SP 4 and 6 Malviya Industrial Area, near apex circle Malviya Nagar- 302017
Jaipur
RAJASTHAN |
1414101111
Kuldeepsingh122@gmail.com |
| Dr Nitin Chintaman Borse |
Apex Wellness Hospital |
Clinical Research Department, Survey No. 799, Plot No. 187, Behind Prakash Petrol Pump, Govind Nagar- 422009
Nashik
MAHARASHTRA |
2532216974
nitinborse@hotmail.com |
| Dr Rupa Banerjee |
Asian Institute of Gastroenterology |
IBD Department, IBD Center 6th floor, Plot No. 2/3/4/5, Survey No.136/ 1 Mindspace Road, Gachilbowli
Hyderabad
TELANGANA |
9849287530
dr_rupa_banerjee@hotmail.com |
| Dr Prashant Fullabhai Dobariya |
BAPS Pramukh Swami Hospital |
Clinical Research departement, Shri Pramukh Swami Maharaja Marg, Adajan Char Road, Adajan-395009
Surat
GUJARAT |
2612708000
prashantdobariya.baps@gmail.com |
| Dr Ajay Bhalla |
Fortis Hospital |
B-22, Sector 62, Clinical Research Academic Department, Room 2142 Noida-201301
Gautam Buddha Nagar
UTTAR PRADESH |
1204300222
ajaybhalla64@yahoo.co.in |
| Dr Nitin Shanker Behl |
Fortis Hospital |
Clinical Research Department , Basement, Ludhiana, Chandigarh Rd, near Radha Soami Satsang Village, Mundian Kalan-141015
Ludhiana
PUNJAB |
1615222333
nitin.behl@fortishealthcare.com |
| Dr Saumin Shah |
Gujarat Hospital-Gastro and vascular centre |
Department of Gastroenterology, Basement OPD1, Opposite to Shree Ram Petrol Pump, Anand Mahal road, Adajan- 395009
Surat
GUJARAT |
02612782020
dr.sauminpshah@gmail.com |
| Dr Vishwa Mohan Dayal |
Indira Gandhi Institute of Medical Sciences |
Department of Gastroenterology,
Room #180, 3rd floor, OPD Building, Sheikhpura, Baily Road- 800014
Patna
BIHAR |
6122297099
vmdayal@gmail.com |
| Dr Chetan Nalin Mehta |
Shree Giriraj Multispeciality Hospital |
Clinical Trial Department, 27-Navjyot Park Corner, 150 Feet Ring Road-360005
Rajkot
GUJARAT |
2817151200
mehtacn@hotmail.com |
| Dr Rajiv Manhar Mehta |
SIDS Hospital and Research centre, A unit of SIDS Healthcare Pvt, Ltd |
SIDS Hospital and Research centre, JJ Empire and Tapi Villa Building Vijay Nagar Gate No-3, Opposite Gandhi Engineering College, Majura Gate, Ring road- 395002
Surat
GUJARAT |
9879863510
rmgastro@yahoo.com |
| Dr Naresh Kumar Bansal |
Sir Ganga Ram Hospital Institute of Liver Gastroenterology and Pancreatico Biliary Sciences |
Clinical Research Room, First floor, old building Rajinder Nagar -110060
New Delhi
DELHI |
011-42251000
drnbansal@ymail.com |
| Dr Siddhartha Ramakrishna Balakrishnan |
SRM Institutes for Medical Science (SIMS Hospital) |
Department of Gastroenterology , "A" block, 3rd floor, No.1, Jawaharlal Nehru Salai (100 Feet Road), Vadapalani– 600026
Chennai
TAMIL NADU |
044-20002001
drramakrishna.bs@simshospitals.com |
| Dr Pintu Bhakhar |
Unity Trauma Centre and ICU (Unity Hospital) |
Research Department, Basement, Nr. D.R World, opp Raghuvir Business Empire, Aai Mata Raod, Parvat Patiya-395010
Surat
GUJARAT |
912612607000
drpintudbhakhar@gmail.com |
| Dr Kiran Kumar Peddi |
Yashoda Hospitals |
Department of Gastroenterology
Room #306, 3rd floor, Raj Bhavan Road, Somajiguda- 500082
Hyderabad
TELANGANA |
04067776666
kirankpeddi@googlemail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee, Dr Saurabh Kedia |
Submittted/Under Review |
| Apex Wellness Ethics Committee, Dr. Nitin Chintaman Borse |
Approved |
| BAPS Pramukh Swami Hospital Institutional Ethics Committee, Dr Prashant Fullabhai Dobariya |
Approved |
| Ethics Committee, Sir Ganga Ram Hospital, Dr. Naresh Bansal |
Submittted/Under Review |
| Fortis Hospital Institutional Ethics Committee, Dr Ajay Bhalla |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE SRM INSTITUTES FOR MEDICAL SCIENCE, Dr. Siddhartha Ramakrishna Balakrishnan |
Approved |
| Institutional Ethics Committee Apex Hospitals Pvt Ltd, Dr. Kuldeep Singh |
Approved |
| Institutional Ethics Committee, Asian Institute of gastroenterology, Dr. Rupa Banerjee |
Approved |
| Institutional Ethics Committee, Fortis Hospital, Dr. Nitin Shanker Behl |
Approved |
| Institutional Ethics Committee, IGIMS, Dr. Vishwa Mohan Dayal |
Not Applicable |
| Institutional Ethics Committee, Yashoda Academy of Medical Education and Research, Dr Kiran Kumar Peddi |
Not Applicable |
| Shree Giriraj Hospital Research Ethics Committee, Dr. Chetan Nalin Mehta |
Approved |
| Surat Institute of Digestive Sciences Ethics Committee, Dr.Rajiv Mehta |
Approved |
| UNITY HOSPITAL ETHICS COMMITTEE UNITY TRAUMA CENTER AND ICU, Dr Pintu Bhakhar |
Approved |
| UNITY HOSPITAL ETHICS COMMITTEE UNITY TRAUMA CENTER AND ICU, Dr. Saumin Shah |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K508||Crohns disease of both small andlarge intestine, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Guselkumab |
Participants (Group 1 and Group 2) 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. |
| Intervention |
Placebo |
Participants (Group 4) will receive placebo administered by intravenous (IV) infusion. Participants who are eligible and willing to continue placebo may enter the LTE and continue to receive placebo. |
| Comparator Agent |
Ustekinumab |
Participants (Group 3) will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants (nonresponders in Group 4) at Week 12, will receive ustekinumab administered 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. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Have Crohns disease (CD) or fistulizing Crohns 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.
2) Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohns Disease (SES-CD)
3) Have screening laboratory test results within the protocol specified parameters
4) A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
5) Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
|
|
| ExclusionCriteria |
| Details |
1) Current diagnosis of ulcerative colitis or indeterminate colitis
2) Has complications of Crohns disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
3) Unstable doses of concomitant Crohns disease therapy
4) Receipt of Crohns 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)
5) Prior exposure to p40 inhibitors or p19 inhibitors
6) Any medical contraindications preventing study participation
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
- Clinical response at Week 12 and clinical remission at Week 48
- Clinical response at Week 12 and endoscopic response at Week 48
|
Week 12 and Week 48 |
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Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Clinical response at Week 4 |
Week 4 |
| Clinical remission at Week 12 |
Week 12 |
| Endoscopic response at Week 12 |
Week 12 |
| Fatigue response at Week 12 |
Week 12 |
| Clinical remission at Week 12 and endoscopic response at Week 12 |
Week 12 |
| Endoscopic remission (Global definition) at Week 12 |
Week 12 |
| Clinical response at Week 12 and corticosteroid-free clinical remission at Week 48 |
Week 12 and 48 |
| Clinical response at Week 12 and endoscopic remission (Global definition) at Week 48 |
Week 12 and 48 |
| Clinical remission at Week 48 |
Week 48 |
| Endoscopic response at Week 48 |
Week 48 |
| Clinical remission at Week 48 and endoscopic response at Week 48 |
Week 48 |
| Endoscopic remission (Global definition) at Week 48 |
Week 48 |
| Deep remission (Global definition) at Week 48 |
Week 48 |
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Target Sample Size
Modification(s)
|
Total Sample Size="980"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/08/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/05/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="10"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Sandborn WJ, et al; GALAXI-1 Investigators. Guselkumab for the Treatment of Crohns Disease: Induction Results From the Phase 2 GALAXI-1 Study. Gastroenterology. 2022 Feb 5. pii: S0016-5085(22)00102-0. doi: 10.1053/j.gastro.2022.01.047 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of this study is to evaluate the
clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of
guselkumab in participants with Crohn’s disease. This program consists of two
48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). Participants who
complete the 48-week 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. |