Filgotinib in Long-Term Extension Study of Adults With Crohns Disease

• Register: CTRI
• Last refreshed on: 3 April 2023
• Main ID: CTRI/2017/08/009477
• Date of registration: 23-08-2017
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences Inc
• Public title: Filgotinib in Long-Term Extension Study of Adults With Crohns Disease
• Scientific title: A Long-Term Extension Study to Evaluate the Safety of filgotinib in Subjects with Crohnâ??s Disease
• Date of first enrolment: 10-12-2017
• Target sample size: 1000
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19641
• Study type: Interventional
• Study design: Other Method of generating randomization sequence:Computer generated 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: • Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial

• Must have met all eligibility criteria from a Gilead-sponsored CD parent protocol

• Females of childbearing potential must have a negative pregnancy test at Day 1

• Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method of contraception as described in the study protocol, for the duration described

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

• Must have completed all required procedures or met protocol specified

efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib

treatment study for CD
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 individual 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 study protocol

• Use of prohibited medications as outlined in the study 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- Crohnâ??s Disease

Intervention(s)

Intervention1: Filgotinib 200 mg oral tablet
Filgotinib 100 mg oral tablet: Filgotinib 200 mg oral tablet once daily
Filgotinib 100 mg oral tablet once daily
Intervention2: Experimental: filgotinib dose A (blinded dosing),
filgotinib dose A and placebo to match filgotinib dose B
for up to 144 weeks: Drug: filgotinib,
Tablet administered orally once daily,
Other Names:
â?¢ GS-6034
â?¢ GLPG0634,
Drug: placebo,
Tablets administered orally once daily
Intervention3: Experimental: filgotinib dose B (blinded dosing)
filgotinib dose B and placebo to match filgotinib 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
Intervention4: 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
Intervention5: 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-to-match (PTM) filgotinib 200 mg oral tablet
PTM filgotinib 100 mg oral tablet: Placebo-to-match (PTM) filgotinib 200 mg oral tablet once daily
PTM filgotinib 100 mg oral tablet once daily
Control Intervention2: 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 the Percentage of Participants Experiencing Adverse Events and

Abnormal Clinical Laboratory TestsTimepoint: Up to 432 weeks

Secondary Outcome(s)

Change from Baseline in Crohns Disease Activity Index (CDAI) ScoresTimepoint: Baseline and up to 432 weeks

Change from Baseline in PRO2 Scores

PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency.Timepoint: Baseline and up to 432 weeks

Secondary ID(s)

NCT02914600

2016-002763-34

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Klinera Corporation India

Ethics review

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

Surat Institute of Digestive Sciences Ethics Committee, 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: 21/11/2017
Contact:

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

Status: Approved
Approval date: 18/12/2017
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Institutional Ethics Committee- VGM Hospital, Dr VG Mohan Prasad

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
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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

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Approval date: 02/02/2018
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Institutional Ethics Committee, Fortis Memorial Research Institute, Dr Gourdas Choudhuri

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Approval date: 26/02/2018
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Institutional Ethics Committee-Human Research, Dr. Meghraj Ingle

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

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Approval date: 22/03/2018
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Lakeshore Ethics Committee, Dr Abraham Koshy

Status: Approved
Approval date: 06/04/2018
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Institutional Ethics Committee , Global Hospitals, Dr Ravishankar Reddy

Status: Approved
Approval date: 09/04/2018
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Midas multispecialty hospital institutional ethics committee, Dr Amit Agrawal

Status: Approved
Approval date: 20/04/2018
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Institutional Ethics Committee, Max Smart Super Speciality Hospital, Dr. Kaushal Madan

Status: Approved
Approval date: 28/06/2018
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The Ethics Committee,SMS Medical College and Attached Hospital, Dr. Sandeep Nijhawan

Status: Approved
Approval date: 05/07/2018
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Institutional Ethics Committee, Lourdes Hospital, Dr. Dawney Zachariah

Status: Approved
Approval date: 10/08/2018
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Institutional Ethics Committee, King George Medical University, Dr. Ajay Kumar

Status: Approved
Approval date: 10/09/2018
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Institutional Ethics Committee, KLES Dr. Prabhakar Kore, Dr. Varadraj Gokak

Status: Approved
Approval date: 15/09/2018
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Ethics Committee, Bangalore Medical College and Research Institute, Dr Parvesh Kumar Jain

Status: Approved
Approval date: 24/09/2018
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Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Center, Dr. Shine Sadashivan

Status: Approved
Approval date: 05/10/2018
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Institutional Ethics Committee, GSVM Medical College, Kanpur, Dr. Vinay Kumar

Status: Approved
Approval date: 06/10/2018
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Institutional Ethics Committee, B J Medical College & Sassoon G Hospital, Dr. Kiran Kumar Jadhav

Status: Approved
Approval date: 19/12/2018
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Institutional Ethics Committee, P D Hinduja NAtional Hospital & Medical Research Center, Dr Devendra Desai

Status: Approved
Approval date: 11/01/2019
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Ethics Committee, Dispur Hospitals Pvt. Ltd, Dr B.D Goswami

Status: Approved
Approval date: 12/12/2019
Contact:

Institutional Ethics Committee, Asian Institute of Gastroenterology, Dr. Rupa Banerjee

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. Shiren Shetty

Status: Approved
Approval date: 27/01/2021
Contact:

Institutional Ethics Committee, Seth GS Medical College and KEM Hospital, Dr. Aditya Kale

Status: Approved
Approval date: 10/05/2021
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:

BAPS Pramukh Swami Hospital Institutional Ethics Committee, Dr Parshottam Koradia

Status: Not Approved
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ETHICS COMMITTEE, S.P.MEDICAL COLLEGE, Dr Vinita Chodhari

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Ethics Committee,S. L Raheja Hopspital,Dr.Rahul Shah

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Gastroplus Ethics Committee, Gastroplus Digestive Disease Centre Pvt. Ltd. Dr. Ravindra Gaadhe

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

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Maharaja Agrasen Hospital Institutional Ethics Committee, Dr. Vivek Bhatia