| CTRI Number |
CTRI/2020/01/022642 [Registered on: 07/01/2020] Trial Registered Prospectively |
| Last Modified On: |
22/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis
|
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Scientific Title of Study
|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| APD334-301 Amendment 4 dated 22-DEC-2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Suneela Thatte |
| Designation |
Head India Local Solutions Director Early Clinical Development |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
IQVIA RDS (India) Private Limited
Natraj by Rustomjee 6th Floor 194 MV Road Near Western Express Highway Metro Station
Andheri East Mumbai 400069
Mumbai
MAHARASHTRA
400069
India |
| Phone |
912266774242 |
| Fax |
|
| Email |
suneela.thatte@quintiles.com |
|
Details of Contact Person
Public Query
|
| Name |
Suneela Thatte |
| Designation |
Head India Local Solutions Director Early Clinical Development |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
IQVIA RDS (India) Private Limited
Natraj by Rustomjee 6th Floor 194 MV Road Near Western Express Highway Metro Station
Andheri East Mumbai 400069
Mumbai
MAHARASHTRA
400069
India |
| Phone |
912266774242 |
| Fax |
|
| Email |
suneela.thatte@quintiles.com |
|
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Source of Monetary or Material Support
|
| Arena Pharmaceuticals, Inc.
6154 Nancy Ridge Drive, San Diego,
CA 92121, USA
|
|
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Primary Sponsor
|
| Name |
Arena Pharmaceuticals Inc |
| Address |
6154 Nancy Ridge Drive, San Diego,
CA 92121, USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| IQVIA RDSIndia Pvt Ltd |
2nd Floor, Etamin Block, Prestige Technology Park II
Sarjapur-Marathahalli Outer Ring Road,
Bangalore-560103
Karnataka
|
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Countries of Recruitment
|
Latvia
Lebanon
Lithuania
Argentina
Australia
Austria
Belarus
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Egypt
Estonia
France
Georgia
Germany
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Serbia
Slovakia
South Africa
Spain
Switzerland
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America
Republic of Moldova |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Ahuja |
All India Institute of Medical Sciences |
Gastroenterology department Sri Aurobindo Marg Ansari Nagar Ansari Nagar East New Delhi Delhi 110029
New Delhi
DELHI |
9810707170
vineet.aiims@gmail.com |
| Dr Rupa Banerjee |
Asian Institute of Gastroenterology |
IBD center 6th floor H No 6 3 661 Somajiguda Hyderabad Telangana 500082
Hyderabad
TELANGANA |
914023378888
dr_rupa_banerjee@hotmail.com |
| Dr G N Ramesh |
Aster DM Healthcare Ltd |
Gastroenterology department Aster Medcity Aster DM Healthcare Ltd Kuttisahib Road Near Kothad bridge South Chittoor PO Cheranallor Kochi 682027
Thiruvananthapuram
KERALA |
04846699999
drganesh.ramesh@asterhospital.com |
| Dr Gourdas Choudhuri |
Fortis Memorial Research Institute |
Gastroenterology Clinical Research Room, 2nd floor Sec-44 Opp-Huda City Centre Metro Station Gurgaon 122002
Gurgaon
HARYANA |
01244962200
gourdas.choudhuri@fortishealthcare.com |
| Dr Sudhir Gupta |
Government Medical College |
Gastroenterology department, 3rd FloorHanuman Nagar Ajni Road Medical Chowk Ajni Nagpur Maharashtra 440003 India
Nagpur
MAHARASHTRA |
07122744671
sudhirjgupta@gmail.com |
| Dr Nitin Pai |
Grant Medical Foundation Ruby Hall Clinic |
Gastroenterology Ground floor 1 Survey No 40 B S Dhole Patil Road, Sasoon Road Pune 411001
Pune
MAHARASHTRA |
02066455582
drnitinpai@gmail.com |
| DrVinay Kumar |
GSVM medical College |
Post Graduate Department of Medicine Ground floor Swaroop Nagar Kanpur 208002
Kanpur Nagar
UTTAR PRADESH |
05122535483
dr.vinayschan@gmail.com |
| Dr Shrikant Mukewar |
Midas multispecialty Hospital |
Gastroenterology 4th floor Midas Heights 7 Central Bazar Road Ramdaspeth Nagpur 440010.
Nagpur
MAHARASHTRA |
07122430511
shrikant_mukewar@yahoo.com |
| Dr Saumin P Shah |
Nirmal Hospital Pvt Ltd |
Gastroenterology Clinical Research Department, 5th Floor Nirmal Hospital Pvt Ltd., Ring Road, Surat – 395002.
Surat
GUJARAT |
02612333999
dr.sauminpshah@gmail.com |
| DrMukesh Kalla |
SR Kalla Memorial Gastro & General Hospital |
Clinical Research 1st Floor 78 79 Dhuleshwar Garden S P Marg Behind HSBC Bank C Scheme Jaipur Rajasthan 302001
Jaipur
RAJASTHAN |
01412378001
drmkalla@rediffmail.com |
| Dr Rajiv Mehta |
Surat Institute of Digestive Sciences |
Gastroenterology Department Vijay Nagar Gate No-3 Besides Nirman Bhavan Opposite Gandhi College Majura Gate Ring Road Surat 395002
Surat
GUJARAT |
912612800000
rmgastro@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
Submittted/Under Review |
| Ethics Committee GSVM medical College Swaroop Nagar Kanpur 208002 |
Submittted/Under Review |
| Institutional Ethics Committee Asian Institute of Gastroenterology 6 3 661 Somajiguda Hyderabad Hyderabad Telangana |
Submittted/Under Review |
| Institutional Ethics Committee Fortis Memorial Research Institute Sec 44 Opp Huda City Centre Metro Station Gurgaon 122002 |
Approved |
| Institutional Ethics Committee GMCNagpur |
Submittted/Under Review |
| Institutional Ethics Committee Heights 7 Central Bazar Road Ramdaspeth Nagpur 440010 |
Approved |
| Institutional ethics Committee Kuttisahib Road Near Kothad bridge South Chittoor PO Cheranallor Kochi 682027 |
Submittted/Under Review |
| Institutional Ethics Committee Poona Medical Research Foundation Ruby Hall Clinic Survey No 40 B S Dhole Patil Road Sasoon Road Pune 411001 |
Approved |
| Nirmal Hospital Pvt Ltd Ethics Committee Ring Road Surat 395002 |
Approved |
| SR Kalla Memorial Ethical Committee for Human Research 78 79 Dhuleshwar Garden S P Marg Behind HSBC Bank C Scheme Jaipur 302001 |
Approved |
| Surat Institute of Digestive Sciences Ethics Committee Surat Institute of Digestive Sciences Vijay Nagar Gate No-3 Besides Nirman Bhavan Opposite Gandhi College Majura Gate |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ulcerative Colitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etrasimod |
2-mg Film Coated Tablet, Oral, once daily, up to 52 weeks of treatment |
| Comparator Agent |
The placebo product is Placebo Matching tablet |
oral, once daily, up to 52 weeks of treatment. |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
Active UC confirmed by endoscopy
|
|
| ExclusionCriteria |
| Details |
Severe extensive colitis
Diagnosis of Crohns disease or indeterminate colitis or the presence or history of a fistula consistent with CD
Diagnosis of microscopic colitis ischemic colitis or infectious colitis
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub scores Time Frame Week 12 |
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub scores Time Frame Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub scores Time Frame Week 52
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub scores Time Frame Week 12
|
Proportion of participants With Clinical Remission Assessed by Mayo Component Sub scores and no Corticosteroid use for ≥ 12 Weeks Time Frame: Week 52
Proportion of Participants With Mucosal Healing Assessed by Geboes Index Scores Time Frame Week 52
Proportion of Participants With Mucosal Healing Assessed by Geboes Index Scores Time Frame Week 12
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub scores Time Frame Week 12 and Week 52
|
|
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Target Sample Size
|
Total Sample Size="372"
Sample Size from India="50"
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)
Modification(s)
|
26/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/06/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The purpose of this study is to determine whether etrasimod is a safe
and effective treatment for moderately to severely active ulcerative colitis. Eligible
subjects will be randomized to receive either etrasimod or matching placebo
once daily in a double-blind fashion for up to 52 weeks of treatment.
The duration of study
treatment is up to 52 weeks, which includes 12- and 40-Week Treatment Periods.
The 40-Week Treatment Period is expected to provide adequate time for
separation of efficacy effects between etrasimod and placebo. The 2-Week
Follow-Up visit will provide off-treatment safety information.
|