Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

• Register: CTRI
• Last refreshed on: 3 April 2023
• Main ID: CTRI/2017/09/009708
• Date of registration: 11-09-2017
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences Inc
• Public title: Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
• Scientific title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
• Date of first enrolment: 15-12-2017
• Target sample size: 1000
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19650
• Study type: Interventional
• Study design: Other Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Serbia , Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States of America

Contacts

• Name: Dr Sherin Eddin
• Affiliation: Klinera Corporation India

• Name: Mr Pritesh Tailor
• Affiliation: Klinera Corporation India

Key inclusion & exclusion criteria

Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

1) Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial

2) Must have met all eligibility criteria from a Gilead-sponsored UC parent protocol

3) Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC

4) Females of childbearing potential must have a negative pregnancy test at Day 1 and must

agree to continued monthly pregnancy testing during use of filgotinib treatment

5) 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, for the duration described

6) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug


Exclusion criteria: Key Exclusion Criteria:

• Known hypersensitivity to the study drug

• Any chronic medical condition-including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse that; in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol

• Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the participants

• Use of prohibited medications as outlined in the protocol



NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Ulcerative Colitis

Intervention(s)

Intervention1: Experimental: filgotinib dose A (blinded dosing),
filgotinib dose A and placebo to match dose B for up to
144 weeks: Drug: filgotinib,
Tablets administered orally once daily,
Other Names:
â?¢ GS-6034
â?¢ GLPG0634
Drug: placebo,
Tablets administered orally once daily
Intervention2: Experimental: filgotinib dose B (blinded dosing),
filgotinib dose B and placebo to match dose A for up to
144 weeks: Drug: filgotinib,
Tablets administered orally once daily,
Other Names: â?¢ GS-6034 â?¢ GLPG0634
Drug: placebo,
Tablets administered orally once daily
Intervention3: Experimental: filgotinib dose A (open-label),
filgotinib dose A for up to 144 weeks: Drug: filgotinib,
Tablets administered orally once daily,
Other Names:
â?¢ GS-6034
â?¢ GLPG0634
Intervention4: Experimental: filgotinib dose B (open-label),
filgotinib dose B for up to 144 weeks: Drug: filgotinib,
Tablets administered orally once daily,
Other Names:
â?¢ GS-6034
â?¢ GLPG0634
Control Intervention1: Placebo Comparator: placebo (blinded dosing),
placebo for up to 144 weeks: Drug: placebo,
Tablets administered orally once daily

Primary Outcome(s)

Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory TestsTimepoint: Up to 336 weeks

Secondary Outcome(s)

Change From Baseline in Components of Mayo Clinic Score or MCSTimepoint: Baseline and up to 336 weeks

Secondary ID(s)

NCT02914535

2016-002765-58

Source(s) of Monetary Support

Gilead Sciences Inc 333 Lakeside Drive Foster City, CA 94404, USA

Ethics review

Status: Approved
Approval date: 07/06/2017
Contact:

Surat Institute of Digestive Sciences Ethics Committee, Surat Institute of Digestive Sciences, Dr.Rajiv Mehta

Status: Approved
Approval date: 14/06/2017
Contact:

SR Kalla Memorial Ethical Committee for Human Research, S.R.Kalla Memorial Gastro & General Hospital,Dr.Mukesh Kalla

Status: Approved
Approval date: 19/06/2017
Contact:

Kaizen Ethics Committee, Kaizen Hospital, Institute of Gastroenterology and Research Centre, Dr.Atul Shah

Status: Approved
Approval date: 19/06/2017
Contact:

Shree Giriraj Hospital Research Ethics Committee, Dr. Chetan Mehta

Status: Approved
Approval date: 27/06/2017
Contact:

Institutional Ethics Committee Poona Medical Research Foundation,Dr.Nitin Pai

Status: Approved
Approval date: 29/06/2017
Contact:

Ethics Committee, M S Ramaiah Medical College and Hospitals,Dr.Sathyaprakash B.S

Status: Approved
Approval date: 04/07/2017
Contact:

Ethics Committee, PVS Memorial Hospital Pvt Ltd,Dr.Mathew Philip

Status: Approved
Approval date: 19/07/2017
Contact:

Institutional Ethics Committee,Midas Multispeciality Hospital Pvt LTD,Dr.Shrikant Mukewar

Status: Approved
Approval date: 08/08/2017
Contact:

Institutional Ethics Committee, Gandhi Medical College, Dr. P. Shravan Kumar

Status: Approved
Approval date: 12/08/2017
Contact:

Institutional Ethics Committee â?? BGS Global Hospital,BGS Global Hospitals, Dr. Ravindra B.S.

Status: Approved
Approval date: 12/08/2017
Contact:

Institutional Ethics Committee, Deccan College of Medical Science, Owaisi Hospital & Research Centre, Dr. Aejaz Habeeb

Status: Approved
Approval date: 12/08/2017
Contact:

Manipal University Ethics Committee, Dr. B.Vishwanath Tantry

Status: Approved
Approval date: 25/08/2017
Contact:

IPGME&R Research Oversight Committee, Dr. Gopal Krishna Dhali

Status: Approved
Approval date: 15/09/2017
Contact:

Ethics Committee for Research , Fortis Flt. Lt. Rajan Dhall Hospital, Dr. Subrat Kumar Acharya

Status: Approved
Approval date: 24/10/2017
Contact:

Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), Dr.Vineet Ahuja

Status: Approved
Approval date: 13/11/2017
Contact:

Institutional Ethics Committee, Sterling Hospital, Dr Pankaj Jain

Status: Approved
Approval date: 13/11/2017
Contact:

Samvedna Hospital Ethics Committee, Dr. Hemant Gupta

Status: Approved
Approval date: 18/11/2017
Contact:

Institutional Ethics Committee , Dr Prasad Bhate

Status: Approved
Approval date: 24/11/2017
Contact:

Drug Trial Ethics Committee,Dayanand Medical College & Hospital, Dr. Ajit Sood

Status: Approved
Approval date: 02/12/2017
Contact:

Institutional Ethics Committee- VGM Hospital, Dr VG Mohan Prasad

Status: Approved
Approval date: 23/12/2017
Contact:

The Ethics Committee, SMS Medical College and Attached Hospital, Dhnavantri OPD Block, SMS Hospital,Dr.Sandeep Nijhawan

Status: Approved
Approval date: 11/01/2018
Contact:

Dr. B.L.Kapur Memorial Hospital Ethics Committee, Dr Yogesh Batra

Status: Approved
Approval date: 17/01/2018
Contact:

Institutional Ethics Committee â?? Clinical Studies, Apollo Hospitals, Apollo Hospitals Enterprise Limited,Dr.Ganesh Subramanian

Status: Approved
Approval date: 20/01/2018
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Institutional Ethics Committee, Apollo Gleneagles Hospitals, Dr Mahesh Kumar Goenka

Status: Approved
Approval date: 02/02/2018
Contact:

Institutional Ethics Committee, Fortis Memorial Research Institute, Dr Gourdas Choudhuri

Status: Approved
Approval date: 26/02/2018
Contact:

Committee-Human Research, Dr. Meghraj Ingle

Status: Approved
Approval date: 27/02/2018
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Institutional Ethics Committee, S. A. L. Hospital and Medical Institute, Dr Sushil Narang

Status: Approved
Approval date: 05/03/2018
Contact:

Institutional Ethics Committee, KLES Dr. Prabhakar Kore, Dr. Varadraj Gokak

Status: Approved
Approval date: 09/04/2018
Contact:

Midas multispecialty hospital institutional ethics committee, Dr Amit Agrawal

Status: Approved
Approval date: 20/04/2018
Contact:

Institutional Ethics Committee, Max Smart Super Speciality Hospital, Dr. Kaushal Madan

Status: Approved
Approval date: 23/06/2018
Contact:

Ethics Committee, Bangalore Medical College and Research Institute, Dr Parvesh Kumar Jain

Status: Approved
Approval date: 05/07/2018
Contact:

Institutional Ethics Committee, Lourdes Hospital, Dr. Dawney Zachariah

Status: Approved
Approval date: 13/08/2018
Contact:

Lakeshore Ethics Committee, Dr Abraham Koshy

Status: Approved
Approval date: 27/09/2018
Contact:

Institutional Ethics Committee, Seth GS Medical College and KEM Hospital,Dr.Deepak Kumar Gupta

Status: Approved
Approval date: 05/10/2018
Contact:

Institutional Ethics Committee, GSVM Medical College, Kanpur, Dr. Vinay Kumar

Status: Approved
Approval date: 06/10/2018
Contact:

Institutional Ethics Committee, B J Medical College & Sassoon G Hospital,Dr. Kiran Kumar Jadhav

Status: Approved
Approval date: 19/12/2018
Contact:

Institutional Ethics Committee, P D Hinduja NAtional Hospital & Medical Research Center, Dr Devendra Desai

Status: Approved
Approval date: 21/01/2019
Contact:

Ethics Committee, Dispur Hospitals Pvt. Ltd, Dr B.D Goswami

Status: Approved
Approval date: 05/02/2020
Contact:

Institutional Ethics Committee,Sunshine Hospitals, Dr. Rohan Reddy

Status: Approved
Approval date: 07/03/2020
Contact:

Manipal University Ethics Committee,Dr.Shiran Shetty

Status: Approved
Approval date: 25/03/2021
Contact:

Institutional Ethics Committee , Global Hospitals, Dr Rami Reddy

Status: Approved
Approval date: 22/06/2021
Contact:

Institutional Ethics Committee, Citizens Hospital, Dr. Abhiram Kognati

Status: Not Approved
Approval date:
Contact:

Ethics Committee, S. L Raheja, Dr Rahul Shah

Status: Not Approved
Approval date:
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Institutional Ethics Committee , Global Hospitals, Dr Ravishankar Reddy

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Center, Dr. Shine Sadashivan

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, RGGGH, MMC, Dr. Venkateswaran Arcot Rajeshwaran