Filgotinib in the Induction and Maintenance of Remission in Adults With
Moderately to Severely Active Ulcerative Colitis
Scientific Title of Study
Combined Phase 2b/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 Ulcerative Colitis
Hong Kong India Japan Mexico New Zealand Portugal South Africa Spain Sweden Switzerland Taiwan Ukraine United Kingdom United States of America Hungary Iceland Ireland Israel Italy Republic of Korea Romania Russian Federation Slovakia Australia Austria Belgium Bulgaria Croatia Czech Republic Germany Greece Poland Argentina Canada France Georgia Malaysia Netherlands Norway Serbia Singapore Sri Lanka
Dept. of Gastroenterology, Tagore Nagar, Civil Lines, Ludhiana PUNJAB
911614688800
ajitsood10@gmail.com
Dr Aejaz Habeeb
Deccan College of Medical Sciences,Owaisi Hospital& Reaserch Centre
Dept. of Gastroenterology, Kanchan bagh, Hyderabad ANDHRA PRADESH
914024340169
aejazhabeeb@hotmail.com
Dr Yogesh Batra
Dr. B. L. Kapur Memorial Hospital
Dr. B. L. Kapur
Memorial Hospital,
Pusa Road, New Delhi DELHI
91-1130403040
dryogeshbatra@gmail.com
Dr Subrat Kumar Acharya
Fortis Flt. Lt. Rajan Dhall Hospital
Institute of Gastroenterology & Liver Disease, Sector B,Pocket 1, Aruna Asaf
Ali Marg,Vasant Kunj, New Delhi DELHI
01142776222
subratacharya@gmail.com
Dr Gourdas Choudhuri
Fortis Memorial Research Institute
Fortis Memorial
Research
Institute,Sector - 44,
Opposite HUDA City
Centre, Gurugram,
Gurgaon HARYANA
91-01244962227
choudhuri.gour@gmail.com
Dr P Shravan Kumar
Gandhi Hospital
New Bhoiguda Road, 5th
Floor, Department of Gastroenterology,
Hyderabad ANDHRA PRADESH
914027505566
shravangastro@gmail.com
Dr Rakesh Kumar Adi
Gleneagles Global Hospitals
Gleneagles Global Hospitals, 6-1-1070/1 to 4, Lakdikapul, Opposite Dwarka Hotel- Hyderabad ANDHRA PRADESH
91-40-232444444
rakeshkumaradi@yahoo.co.in
Dr Ravindra B S
Global Hospital
Dept. of Gastroenterology, 67,Uttarahall, Main Road,
Kengeri Bangalore KARNATAKA
918030444444
drravindrabs@gmail.com
Dr Nitin Pai
Grant Medical Foundation Ruby Hall Clinic
Dept. of Gastroenterology,40 Sassoon Road, Pune MAHARASHTRA
912066455100
drnitinpai@gmail.com
Dr Vinay Kumar
GSVM Medical College
Department of Post Graduate Medicine,GSVM Medical College,Kanpur-208002 Kanpur Nagar UTTAR PRADESH
91-8008177113
dr.vinaysachan@gmail.com
Dr BD Goswami
Institute of digestive and liver disease, Dispur Hospitals Pvt Ltd
Institute of digestive and liver disease, Dispur Hospitals Pvt
Ltd, Ganeshguri, Guwahati Kamrup ASSAM
91-3612221962
bhabadev@rediffmail.com
Dr Venkateswaran Arcot Rajeshwaran
Institute of Medical Gastroenterology
4th Floor, Institute of Medical Gastroenterology, RGGGH, MMC Chennai TAMIL NADU
91-7904285567
dr.venkateswaranar@gmail.com
Dr Gopal Krishna Dhali
Institute of Post Graduate Medical Education and Research
Dept. of Gastroenterology, Ronald Ross building, 4th floor,Room No- 17, 244 AJC bose road Kolkata WEST BENGAL
913322235181
gkdhali@yahoo.co.in
Dr Atul Shah
Kaizen Hospital,
Institute of Gastroenterology and Research Centre, 132 Feet Ring Road, Near
Helmet Circle, Ahmadabad GUJARAT
917927914444
atulshah@kaizenhospital.com
Dr Ganesh Pai
Kasturba Medical College Hospital
Dept. of Gastroenterology, Manipal,
Udupi KARNATAKA
918202571201
cgpai@yahoo.co.in
Dr Vishwanath Tantry
Kasturba Medical College Hospital
Dept. of Gastroenterology, Ambedkar Circle, Mangalore Udupi KARNATAKA
918242445858
tantrybv@gmail.com
Dr Varadaraj P Gokak
KLES Dr. Prabhakar Kore Hospital & M.R.C
2nd Floor, KLES Dr. Prabhakar Kore Hospital & M.R.C,NH Service Road,Nehru Nagar,Belgaum Belgaum KARNATAKA
91-7353691777
vpgokak@gmail.com
Dr Abraham Koshy
Lakeshore Hospital & Research Centre Ltd
Lakeshore Hospital & Research Centre Ltd, NH Bypass, Nettoor, Ernakulam KERALA
91-4842772033
koshyabe@yahoo.com
Dr Meghraj Ingle
Lokmanya Tilak Municipal General Hospital
2nd floor, Dept of Gastroenterology, Lokmanya Tilak Municipal General Hospital Dr. Babasaheb Ambedkar Road, Sion,
Mumbai MAHARASHTRA
91-2224076381
drmeghraj@gmail.com
Dr Dawney Zachariah
Lourdes Hospital
1st Floor, Lourdes Hospital, Panchalam PO, Ernakulam KERALA
91-8589951229
drdawneyzachariahlh@gmail.com
Dr Sathyaprakash B S
M S Ramaiah Medical College and Hospital
Dept. of Gastroenterology,M S Ramaiah Nagar, MSRIT Post, Bangalore KARNATAKA
918023605190
satyaprakash@gmail.com
Dr Kaushal Madan
Max Smart Super Speciality Hospital
Ground floor, 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
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 MAHARASHTRA
917122434242
shrikant_mukewar@yahoo.com
Dr Devendra Desai
P D Hinduja National Hospital & Medical Research Center
2nd floor, P D Hinduja National Hospital & Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai (Suburban) MAHARASHTRA
91-9322596152
dr_ddesai@hindujahospital.com
Dr Mathew Philip
PVS Hospital
Dept. of Gastroenterology, Banerji Rd, Kaloor, Ernakulam,
Ernakulam KERALA
Induction Study;
Experimental: filgotinib dose A,
filgotinib dose A and placebo to match filgotinib dose B
for 10 weeks
Drug: filgotinib,
Tablets administered orally once daily,
Other Names:
GS-6034
GLPG0634,
Drug: placebo to match filgotinib,
Tablets 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,
Tablets administered orally once daily,
Other Names:
GS-6034
GLPG0634,
Drug: placebo to match filgotinib,
Tablets administered orally once daily
Comparator Agent
Induction Study; Placebo Comparator:
placebo to match dose A and placebo to match dose B for 10 weeks
Drug: placebo to match filgotinib,
Tablets administered orally once daily
Intervention
Maintenance Study; Experimental:
participants who meet response or remission criteria
at Week 10 will continue into maintenance study and
will receive filgotinib and or placebo for 48 weeks
Drug: filgotinib,
Tablets administered orally once daily,
Other Names:
GS-6034
GLPG0634,
Drug: placebo to match filgotinib,
Tablets administered orally once daily
Subjects must meet all of the following inclusion criteria to be eligible for participation in either the Cohort A or B Induction Study.
1) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
2) Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
3) Females of childbearing potential (as defined in Appendix 6) must have a negative pregnancy
test at screening and baseline
4) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 6
5) Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of
15 cm from the anal verge. Documentation should include endoscopic and histopathologic
evidence of UC as follows:
a) The criteria for documentation of UC based on endoscopy will be medical record
documentation of, or an ileocolonoscopy (full colonoscopy with the intubation of the
terminal ileum) report dated ≥ 6 months before enrollment, which shows features
consistent with UC, determined by the procedure performing physician
b) The criteria for documentation of UC based on histopathology will be medical record
documentation of or a histopathology report indicating features consistent with UC as
determined by the pathologist
6) A surveillance colonoscopy is required at screening in subjects with a history of UC for 8 or more years, if one was not performed in the prior 24 months
ExclusionCriteria
Details
Key Exclusion Criteria:
• Presence of Crohn’s disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
• Active tuberculosis or history of latent TB that has not been treated
• Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Induction Study: Proportion of Participants Achieving MCS Remission at Week 10
Week 10
Induction Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10
Week 10
Induction Study: Proportion of Participants Achieving Histologic Remission at Week 10
Week 10
Induction Study: Proportion of participants achieving MCS remission at Week 10
Week 10
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845
Week 4 postdose and Week 10 predose
Maintenance Study: Proportion of Participants Achieving MCS Remission at Week 58
Week 58
Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and
58
Week 10 and Week 58
Maintenance Study: Proportion of Participants Achieving 6-Month Corticosteroid-Free Remission Based on
Components of MCS at Week 58
Week 58
Maintenance Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 58
Week 58
Maintenance Study: Proportion of Participants Achieving Histologic Remission at Week 58
Week 58
Maintenance Study: Proportion of participants achieving MCS remission 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="1300" Sample Size from India="150" 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 in the induction and maintenance treatment of moderately to severely active ulcerative colitis 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 that is, Gilead Study GS-US-418-3899