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CTRI Number  CTRI/2023/05/052646 [Registered on: 15/05/2023] Trial Registered Prospectively
Last Modified On: 19/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study evaluating the effect of Filgotinib dose de-escalation in patients with ulcerative colitis in remission 
Scientific Title of Study   A randomized, double-blind, controlled, multi-center study to evaluate the efficacy and safety of dose de-escalation of orally administered Filgotinib in subjects with ulcerative colitis in clinical remission. 
Trial Acronym  CAPYBARA 
Secondary IDs if Any  
Secondary ID  Identifier 
2022-000719-30  EudraCT 
GLPG0634-CL-341 version 1.0 dated 04-Apr-2022  Protocol Number 
NCT05479058  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Aparna Parikh 
Designation  Executive Director, Therapeutic Expertise & Country Consultant for India 
Affiliation  Pharmaceutical Research Associates India Private Limited 
Address  Pharmaceutical Research Associates India Private Limited, Level 2, B- wing, Times Square, Andheri - Kurla Road, Andheri (East), Mumbai, Maharashtra, India

Mumbai
MAHARASHTRA
400059
India 
Phone  914449032707  
Fax  912266089696  
Email  Aparna.Parikh@iconplc.com  
 
Details of Contact Person
Public Query  
Name  Dr Aparna Parikh 
Designation  Executive Director, Therapeutic Expertise & Country Consultant for India 
Affiliation  Pharmaceutical Research Associates India Private Limited  
Address  Pharmaceutical Research Associates India Private Limited, Level 2, B- wing, Times Square, Andheri - Kurla Road, Andheri (East), Mumbai, Maharashtra, India

Mumbai
MAHARASHTRA
400059
India 
Phone  914449032707  
Fax  912266089696  
Email  Aparna.Parikh@iconplc.com  
 
Source of Monetary or Material Support  
Galapagos NV, Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium 
 
Primary Sponsor  
Name  Galapagos NV 
Address  Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Pharmaceutical Research Associates India Private Limited  Level 2, B- wing, Times Square, Andheri - Kurla Road, Andheri (East), Mumbai – 400059 Maharashtra, India 
 
Countries of Recruitment     Belgium
Czech Republic
France
Germany
Hungary
India
Italy
Poland
Republic of Korea
South Africa
Spain
Switzerland
Taiwan
United Kingdom
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Y Rami Reddy  Gleneagles Global Hospitals  6-1-1070/1 to 4, Lakdi-ka-pul, Hyderabad
Hyderabad
TELANGANA 		 9815192032

yrrpgi@gmail.com 
Dr Nitin Vikas Pai  Grant Medical Foundation, Ruby Hall Clinic  40, Sasoon road, Pune – 411001, Maharashtra, India
Pune
MAHARASHTRA 		 9822008682
02066455628
drnitinpai@gmail.com 
Dr B Vishwanath Tantry  Kasturba Medical College and Hospital  Department of Gastroenterology, Dr. B. R. Ambedkar Circle, Mangalore – 575001
Udupi
KARNATAKA 		 08242444590

tantrybv@gmail.com 
Dr Meghraj Ananda Ingle  Lokmanya Tilak Municipal Medical College & General Hospital Sion  Gastroenterology Department, 1st Floor, Room no. 2, College Building, Dr. Babasaheb Ambedkar Road, Sion, Mumbai – 400022
Mumbai
MAHARASHTRA 		 9320979659
02224076100
drmeghraj@gmail.com 
Dr Avinash Balekuduru  M S Ramaiah Medical College and Hospitals  Department of Gastroenterology, M S Ramaiah Medical College and Hospitals, M S Ramaiah Nagar, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA 		 08040503199
08023601983
contact@msrmh.com 
Dr Mukewar Shrikant Vasantrao  Midas Multispecialty Hospital Pvt Ltd  Midas Heights 07, Central Bazar Road, Ramdaspeth, Nagpur – 440010
Nagpur
MAHARASHTRA 		 917122434242
917122442536
shrikant_mukewar@yahoo.com 
Dr Mohd Aejaz Habeeb  Owaisi Hospital & Research Center  Department of Gastroenterology and Hepatology, Deccan College of Medical Sciences, Kanchanbagh, Hyderabad – 500058
Hyderabad
TELANGANA 		 8328481966

aejazhabeeb@hotmail.com 
Dr Sandeep Nijhawan  S.M.S Super Specialty Hospital  Department of Gastroenterology, Vivekananda Marg, C-Scheme, Jaipur – 302004
Jaipur
RAJASTHAN 		 9887870552

dhananjaynephro@gmail.com 
Dr Hemant Kumar Gupta  Samvedna Hospital  B27/88G, New Colony, Ravidrapuri Varanasi-221005
Varanasi
UTTAR PRADESH 		 05422276890
05422276890
hemantg26@yahoo.com 
Dr Mehta Chetan Nalin  Shree Giriraj Multispecialty Hospital   27 Navjyot Park Corner , 150 feet ring road , Rajkot-360005 ,Gujarat , India
Rajkot
GUJARAT 		 9825077472

mehtacn@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee, M S Ramaiah Medical College And Hospitals  Not Applicable 
Ethics Committee, Poona Medical Research Foundation  Not Applicable 
Ethics Committee, S.M.S. Medical College and Attached Hospitals  Not Applicable 
Institutional Ethics Committee for Human Research, Lokmanya Tilak Municipal Medical College (IEC-HR-LTMMC)  Not Applicable 
Institutional Ethics Committee, Deccan College of Medical Sciences and Allied Deccan College Of Medical Sciences Allied Hospitals  Approved 
Institutional Ethics Committee, Gleneagles Global Hospitals  Not Applicable 
Institutional Ethics Committee, Midas Multispecialty Hospital Pvt Ltd  Not Applicable 
MAHE Ethics Committee, Manipal Academy of Higher Education,  Not Applicable 
Samvedna Hospital Ethics Committee  Not Applicable 
Shree Giriraj Hospital Research Ethics Committee  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K515||Left sided colitis, (2) ICD-10 Condition: K518||Other ulcerative colitis, (3) ICD-10 Condition: K513||Ulcerative (chronic) rectosigmoiditis, (4) ICD-10 Condition: K51||Ulcerative colitis, (5) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Filgotinib 100mg  One 100mg tablet per day. Blinded treatment duration as per the study design using blinded IP kits is 48 weeks As per the Protocol, Subjects will receive blinded treatment until the primary analysis time point (i.e. after the last subject completed their Week 48 postbaseline visit or has completed their Week 12 post reescalation visit, or after the last follow-up of subjects discontinuing prior to Week 48, whichever comes last), with the exception of subjects with ES-confirmed UC flare who will be switched to open-label 200 mg filgotinib. Hence, there is a chance that subjects who are in blinded treatment phase for more than 48 weeks because of the study design (subjects can only switch to open label once ALL global subjects complete 48 weeks, so some subjects earlier enrolled can be in blinded phase for more than 48 weeks). Subjects who experience an ES-confirmed UC flare during treatment will be reescalated to open-label 200mg Filgotinib q.d. for at least 12 weeks, while maintaining the blind for the treatment at randomization. We assume that 50% of the Indian Subjects i.e., 10 randomized subjects may experience the flare and will be re-escalated to the 200mg Filgotinib open label during the blinded treatment: Treatment duration is 52 weeks Total duration of open label treatment is 92 weeks 
Intervention  Filgotinib 200mg  One 200mg tablet per day. Blinded treatment duration as per the study design using blinded IP kits is 48 weeks As per the Protocol, Subjects will receive blinded treatment until the primary analysis time point (i.e. after the last subject completed their Week 48 postbaseline visit or has completed their Week 12 post reescalation visit, or after the last follow-up of subjects discontinuing prior to Week 48, whichever comes last), with the exception of subjects with ES-confirmed UC flare who will be switched to open-label 200 mg filgotinib. Hence, there is a chance that subjects who are in blinded treatment phase for more than 48 weeks because of the study design (subjects can only switch to open label once ALL global subjects complete 48 weeks, so some subjects earlier enrolled can be in blinded phase for more than 48 weeks). Subjects who experience an ES-confirmed UC flare during treatment will be reescalated to open-label 200mg Filgotinib q.d. for at least 12 weeks, while maintaining the blind for the treatment at randomization. We assume that 50% of the Indian Subjects i.e., 10 randomized subjects may experience the flare and will be re-escalated to the 200mg Filgotinib open label during the blinded treatment: Treatment duration is 52 weeks Total duration of open label treatment is 92 weeks 
Comparator Agent  Placebo to Match Filgotinib  One Placebo tablet per day. Blinded treatment duration as per the study design using blinded IP kits is 48 weeks As per the Protocol, Subjects will receive blinded treatment until the primary analysis time point (i.e. after the last subject completed their Week 48 postbaseline visit or has completed their Week 12 post reescalation visit, or after the last follow-up of subjects discontinuing prior to Week 48, whichever comes last), with the exception of subjects with ES-confirmed UC flare who will be switched to open-label 200 mg filgotinib. Hence, there is a chance that subjects who are in blinded treatment phase for more than 48 weeks because of the study design (subjects can only switch to open label once ALL global subjects complete 48 weeks, so some subjects earlier enrolled can be in blinded phase for more than 48 weeks). Subjects who experience an ES-confirmed UC flare during treatment will be reescalated to open-label 200mg Filgotinib q.d. for at least 12 weeks, while maintaining the blind for the treatment at randomization. We assume that 50% of the Indian Subjects i.e., 10 randomized subjects may experience the flare and will be re-escalated to the 200mg Filgotinib open label during the blinded treatment: Treatment duration is 52 weeks Total duration of open label treatment is 92 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Subjects must be participating in the SELECTION-LTE study, currently on 200 mg Filgotinib q.d. and fulfill the following conditions:
a) pMCS remission1 over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study prior to and including screening of the present study
b) free of corticosteroids for at least 12 weeks prior to and including baseline
c) FCP less than or equals to 250 microgram per gram at last observation
d) sigmoidoscopy ES of 0 or 1 (local score) at screening.
2) Female subjects of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must agree to continued monthly urine dipstick pregnancy testing during Filgotinib treatment.
3) Male subjects and female subjects of childbearing potential must agree to use highly effective contraception measures as defined in the protocol.
4) Willing to refrain from live attenuated vaccines during the study and for 12 weeks after the last dose of Filgotinib in the study.
 
 
ExclusionCriteria 
Details  1) Any chronic medical condition (including but not limited to, cardiac or pulmonary disease, alcohol, or drug abuse) that, in the opinion of the investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol.
2) Subject has a known hypersensitivity to Filgotinib ingredients or history of a significant allergic reaction to Filgotinib ingredients as determined by the investigator.
3) Female subject who is pregnant or breastfeeding, or intending to become pregnant or breastfeed, and or or plans to undergo egg donation or egg harvesting for the purpose of current or future fertilization, during the study and until the end of the study.
4) Male subject unwilling to refrain from sperm donation for at least 90 days after the last dose of investigational product.
5) Subject is unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
6) Subject has a positive QuantiFERON® tuberculosis test at screening or subject has 2 indeterminate QuantiFERON® TB test results who require IP treatment interruption.
7) History of malignancy except for subjects who have been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
8) Subject meets discontinuation criteria of the SELECTION-LTE study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48   Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48  
 
Secondary Outcome  
Outcome  TimePoints 
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare   Baseline (Day 1) up to 216 weeks 
Time to ES-Confirmed UC Flare  Baseline (Day 1) up to 216 weeks 
Change From Baseline in C-Reactive Protein (CRP) up to Week 48   Baseline, up to Week 48 
Change From Baseline in Fecal Calprotectin (FCP) up to Week 48   Baseline, up to Week 48 
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48   Baseline, Week 48 
6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation   Baseline up to 216 weeks 
 
Target Sample Size   Total Sample Size="80"
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 3 
Date of First Enrollment (India)   23/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/08/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Participants who are in clinical remission on 200 mg Filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GLPG0634-CL-307, GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of Filgotinib in participants in stable clinical remission on 200 mg Filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d. 
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