Filgotinib in the Induction and Maintenance of Remission in Adults With
Moderately to Severely Active Crohns Disease
Scientific Title of Study
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately
to Severely Active Crohn’s Disease
KlinEra Global Services
801, Neelkanth Corporate Park,
Near Vidyavihar Station,
Vidhyavihar West, Mumbai 400 086, India
KlinEra Global Services
801, Neelkanth Corporate Park,
Near Vidyavihar Station,
Vidhyavihar West, Mumbai 400 086, India
Mumbai MAHARASHTRA 400086 India
KlinEra Global Services,
801, Neelkanth Corporate Park,
Near Vidyavihar Station,
Vidhyavihar West, Mumbai 400 086
KlinEra Global Services,
801, Neelkanth Corporate Park,
Near Vidyavihar Station,
Vidhyavihar West, Mumbai 400 086
Mumbai MAHARASHTRA 400086 India
Phone
917045947271
Fax
912225004588
Email
ptailor@klinera.com
Source of Monetary or Material Support
Gilead Sciences Inc, 333 Lakeside Drive Foster City, CA 94404, USA
Primary Sponsor
Name
Gilead Sciences Inc
Address
333 Lakeside Drive Foster City, CA 94404, USA
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Klinera Corporation India
Klinera Corporation India 401 Industrial Hill View
Ghatkopar west, Mumbai-400086
Australia Austria Bulgaria Canada France Germany Greece Hong Kong India Japan Mexico New Zealand Poland Portugal South Africa Spain Sweden Switzerland Taiwan Ukraine United Kingdom United States of America Belgium Croatia Czech Republic Hungary Iceland Ireland Israel Italy Republic of Korea Romania Russian Federation Slovakia Argentina Georgia Malaysia Netherlands Norway Serbia Singapore Sri Lanka
Dept. of Gastroenterology,Room No.3093, third floor,New Delhi-110029, India New Delhi DELHI
91-1126588500
vins_ahuja@hotmail.com
Dr Shine Sadasivan
Amrita Institute of Medical Science and Research Center
Amrita Institiute of Medical Science and Research Center, Amrita Lane, Elamakkara P O Edappally, Kochi, Ernakulam, Kerala, India Ernakulam KERALA
91-9497556339
shines1560@aims.amrita.edu
Dr Mahesh Kumar Goenka
Apollo Gleneagles Hospitals
Institute of Gastrosciences Day Care Building, 4th Floor, Apollo Gleneagles Hospitals, 58 Canal Circular Road, Kolkata- 700054, West Bengal, India
Kolkata WEST BENGAL
91-3323205218
doctormaheshkumargoenka@gmail.com
Dr Ganesh Subramanian
Apollo Speciality Hospital
Dept. of Gastroenterology, No: 320, Padma complex, Anna salai, Chennai-600035, Tamil Nadu,India Chennai TAMIL NADU
91-4424334455
gastroganesh@gmail.com
Dr Rupa Banerjee
Asian Institute of Gastroenterology
Department of Gastroenterology, Asian Institute of Gastroenterology,6-3-661, Somajiguda, Hyderabad, Telangana 500082
Hyderabad ANDHRA PRADESH
91-23324255
dr_rupa_banerjee@hotmail.com
Dr Ravishankar Reddy
Aware Global Hospital
Aware Global Hospital, 8-16-1, Inner Ring Rd, Laxmi Enclave, Ramakrishnapuram, LB Naga, Hyderabad, Telangana, India Hyderabad ANDHRA PRADESH
91-3848407907
drnravisankar@yahoo.com
Dr Kiran Kumar Jadhav
B J Medical College & Sassoon G Hospital
B.J. Medical College & Sassoon G. Hospital ,Sassoon Road,Pune-411001,Maharashtra,India Pune MAHARASHTRA
91-9823949126 91-20-26126868 drkpjadhav@gmail.com
Dr Samit Jain
B.Y.L Nair CH Hospital and T.N Medical College
Department of Gastroenterology, New OPD Building, 7th Floor, Room no. 717, B.Y.L Nair CH Hospital and T.N Medical College, Dr. A. L. Nair Road, Mumbai-400008, Maharashtra, India.
Mumbai MAHARASHTRA
Institute of Post Graduate Medical Education and Research
School of Digestive & Liver Diseases, Institute of Post Graduate Medical Education and Research, Ronald Ross building, 4th floor, Room No- 17, 244 AJC bose road ,Kolkata- 700020, West Bengal, India Kolkata WEST BENGAL
91-3322235181
gkdhali@yahoo.co.in
Dr Atul Shah
Kaizen Hospital
Institute of Gastroenterology and Research Centre, 132 Feet Ring Road, Near Helmet Circle, Ahmedabad – 380052, Gujarat, India
Ahmadabad GUJARAT
91-7927914444
dratul_aash@yahoo.com
Dr Shiran Shetty
Kasturba Medical College Hospital
Dept. of Gastroenterology, Manipal,Karnataka-576104, India Udupi KARNATAKA
918861920517 91820-2922928 drshiran@gmail.com
Dr V Tantry
Kasturba Medical College Hospital
Dept. of Gastroenterology, Ambedkar Circle, Mangalore-575001, Karnataka, India Udupi KARNATAKA
91-8242445858
tantrybv@gmail.com
Dr Ajay Kumar
King George Medical University
King George Medical University ,Department of Surgical Gastroenterology,King George Medical University,Shah Mina Road,Lucknow-226003,Uttar Pradesh, India. Lucknow UTTAR PRADESH
Max Smart Super Speciality Hospital, Saket
A unit of Gujarmal Modi Hospital & Research Centre for Medical Sciences,
Mandir Marg, Press Enclave Road, Saket, New Delhi, Delhi 110017, India New Delhi DELHI
91-9958787720
k_madan_2000@yahoo.com
Dr Shrikant Mukewar
Midas Multispeciality Hospital Pvt LTD
Dept. of Gastroenterology ,Fourth Floor, 7 - Central Bazar Road, Ramdaspeth, Nagpur - 440 010, Maharashtra, India Nagpur MAHARASHTRA
91-7122442536
shrikant_mukewar@yahoo.com
Dr Devendra Desai
P D Hinduja National Hospital& Medical Research Center
P D Hinduja National Hospital & Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai - 400016, Maharashtra - India Mumbai (Suburban) MAHARASHTRA
Pristine Hospital & Research Centre Pvt Ltd, 877, Dr M C Modi Hospital Rd, K.N Extension, West of chord road, Stage 2, Nagapura, Bangaluru, Karnataka-560086 Bangalore KARNATAKA
91-9845136766
drumeshj@yahoo.com
Dr Mathew Philip
PVS Hospital
Dept. of Gastroenterology, Banerji Rd, Kaloor, Ernakulam, Kerala- 682017, India Ernakulam KERALA
Sardar Patel Medical College & AG Hospital, PBM Hospital
Department Gastroenterology, Bikaner -334 003Rajasthan, India Bikaner RAJASTHAN
91-9782300231
drchaudharyvinita@gmail.com
Dr Aditya Kale
Seth GS medical College and KEM Hospital
Dept. of Gastroenterology, Parel,Mumbai- 400012, Maharashtra, India Mumbai MAHARASHTRA
918962263999 912148-222148 adityapkale@yahoo.com
Dr Chetan Mehta
Shree Giriraj Multispeciality Hospital
Dept. of Gastroenterology, Navjot Park Main Road, 150 Ft Ring Road, Rajkot- 360002, Gujarat, India Rajkot GUJARAT
91-2812587087
mehtacn@hotmail.com
Dr Sandeep Nijhaawan
SMS Medical College and Attached Hospital
Dept. of Gastroenterology,JLN Marg, Jaipur-302004, Rajasthan, India. Jaipur RAJASTHAN
91-1412560291
drnijhawansandeep@gmail.com
Dr Mukesh Kalla
SR Kalla Memorial Gastro & General Hospital
Dept. of Gastroenterology ,78-79, Dhuleshwar Garden, S P Marg, Behind HSBC Bank, Sardar Patel Marg C-Scheme, Jaipur, Rajasthan 302001, India Jaipur RAJASTHAN
91-7023006666
drmkalla@rediffmail.com
Dr Shanthi Vijayaraghvan
Sri Ramchandra Medical Centre
Dept. of Gastroenterology ,No:1,Ramchandra Nagar,Porur,Chennai-600116,Tamil Nadu, India Chennai TAMIL NADU
Experimental: Maintenance Study,
Participants who meet response or remission criteria at Week 10 will continue into the maintenance Study and receive filgotinib and/or placebo for 48 weeks
Drug: filgotinib tablet administered orally once daily,
Other Names
GS-6034
GLPG0634,
Drug: placebo to match filgotinib tablet administered orally once daily
Intervention
Induction Study
Experimental filgotinib dose A
filgotinib dose A and placebo to match filgotinib dose B
for 10 weeks
Drug filgotinib
Tablet administered orally once daily,
Other Names
GS-6034
GLPG0634,
Drug placebo to match filgotinib,
Tablet(s) administered orally once daily
Intervention
Induction Study
Experimental filgotinib dose B
filgotinib dose B and placebo to match filgotinib dose A
for 10 weeks
Drug: filgotinib tablet administered orally once daily,
Other Names:
GS-6034
GLPG0634,
Drug: placebo to match filgotinib tablet administered orally once daily
Comparator Agent
Induction Study
Placebo,
placebo to match filgotinib dose A and placebo to match filgotinib dose B for 10 weeks
Drug: placebo to match filgotinib tablet(s) administered orally once daily
• Males or non-pregnant, non-lactating females, ages 18 to 75 years,
inclusive based on the date of the screening visit
• Documented diagnosis of CD with a minimum disease duration of 3
months with involvement of the ileum and/or colon at a minimum, as
determined by histopathology and endoscopic assessment
• Moderately to severely active CD
• Previously demonstrated an inadequate clinical response, loss of response
to, or intolerance to at least 1 of the following agents: corticosteroids,
immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or
vedolizumab
ExclusionCriteria
Details
• Current complications of CD such as symptomatic strictures, severe rectal/
anal stenosis, short bowel syndrome, etc.
• Presence of ulcerative colitis, indeterminate colitis, ischemic colitis,
fulminant colitis, or toxic mega-colon
• Active tuberculosis (TB) or history of latent TB that has not been treated
• Use of any prohibited concomitant medications as described in the study
protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Induction Study: Proportion of Participants Achieving Clinical Remission by Crohns Disease Activity Index (CDAI) at
Week 10
Week 10
Induction Study: Proportion of Participants Achieving Both Clinical Remission by PRO2 and endoscopic response at
Week 10 (Composite Endpoint)
Week 10
Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845
Week 4 postdose and Week 10 predose
Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58
Week 58
Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2 at Weeks 10 and 58
Week 10 & Week 58
Maintenance Study: Proportion of Participants Achieving Both Clinical Remission by PRO2 and Endoscopic
Response at Week 58 (Composite Endpoint)
Week 58
Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week
58
Week 58
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845
Week 26 (predose or postdose) and Week 58 predose
Target Sample Size
Total Sample Size="1320" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohns disease in participants who are biologic naive and biologic experienced
Participants who complete the study or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long term extension study GS US 419 3896