| CTRI Number |
CTRI/2023/07/054672 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohns Disease. |
|
Scientific Title of Study
|
A PHASE 3, MULTICENTER, OPEN-LABEL EXTENSION STUDY OF ORAL OZANIMOD FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE |
| Trial Acronym |
Yellowstone |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2017-004295-55 |
EudraCT |
| NCT03467958 |
ClinicalTrials.gov |
| RPC01-3204 Version6 dated 14 Jun 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO pharma India Pvt Ltd |
| Address |
PSI CRO Pharma India Pvt Ltd, 414 Shree complex, 73, St Johns Road, Bangalore, India- 560042
Bangalore
KARNATAKA
560042
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
radhika.Bobba@psi-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO pharma India Pvt Ltd |
| Address |
PSI CRO Pharma India Pvt Ltd, 414 Shree complex, 73, St Johns Road, Bangalore, India- 560042
Bangalore
KARNATAKA
560042
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
radhika.Bobba@psi-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO pharma India Pvt Ltd |
| Address |
PSI CRO Pharma India Pvt Ltd, 414 Shree complex, 73, St Johns Road, Bangalore, India- 560042
Bangalore
KARNATAKA
560042
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
radhika.Bobba@psi-cro.com |
|
|
Source of Monetary or Material Support
|
| Celgene International II SÃ rl, Route de Perreux 1, 2017 Boudry, Switzerland |
|
|
Primary Sponsor
|
| Name |
PSI CRO Pharma India Pvt Ltd |
| Address |
414 Shree complex, 73, St Johns Road, Bangalore, India- 560042 |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Belarus
Bosnia and Herzegovina
Bulgaria
Canada
Chile
Croatia
Czech Republic
France
Germany
India
Ireland
Israel
Italy
Latvia
Mexico
Poland
Romania
Saudi Arabia
Switzerland
Turkey
Ukraine
United Kingdom
United States of America
Belgium
Spain
Colombia
Georgia
Greece
Hong Kong
Hungary
Netherlands
Portugal
Republic of Korea
Russian Federation
Serbia
Slovakia
Slovenia
Taiwan
Republic of Moldova |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Ahuja |
All India Institute of Medical Sciences |
Ansari Nagar East, Gautam Nagar, Delhi, 110029, India
New Delhi
DELHI |
9810707170
vineet.aiims@gmail.com |
| Dr Vineet Ahuja |
All India Institute of Medical Sciences, New Delhi |
Ansari Nagar East, Gautam Nagar, Delhi, 110029, India
New Delhi
DELHI |
9810707170
vineet.aiims@gmail.com |
| Dr Shine Sadasivan |
Amrita Institute of Medical Sciences |
AIMS (P.O.), Kochi, Kerala, 682041, India
Ernakulam
KERALA |
9497556339
drshinesivan21@gmail.com |
| Dr Rupa Banerjee |
Asian Institute of Gastroenterology |
No 136, Plot No 2/3/4/5, Survey 1, MindSpace Road, Gachibowli, Hyderabad, Telangana - 50003
Hyderabad
TELANGANA |
9849287530
rupabanerjee.aig@gmail.com |
| Dr Ajit Sood |
Dayanand Medical College & Hospital |
Tagore Nagar, Civil Lines, Ludhiana-141001, Punjab, India
Ludhiana
PUNJAB |
9815400718
ajitsood10@gmail.com |
| Dr Gourdas Choudhuri |
Fortis Memorial Research Institute |
Sector 44, Opposite Huda City Centre, Gurgaon, Haryana, 122002, India
Gurgaon
HARYANA |
9650643222
choudhuri.gour@gmail.com |
| Dr Siddharth Srivastava |
G.B Pant Institute of Post Graduate Medical Education and Research |
Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat New Delhi, Delhi 110002 India
New Delhi
DELHI |
9718599215
docsiddharth1@gmail.com |
| Dr Varadraj P Gokak |
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre |
NH Service Road, Basava Circle, Chikodi, Nehru Nagar, Belgaum, Karnataka, 590010, India
Belgaum
KARNATAKA |
7353691777
vpgokak@gmail.com |
| Dr Sandeep Nijhawan |
SMS Medical College and Attached Hospitals |
Jaipur 1st Floor Dhanvantri OPD block SMS Hospital JLN Marg Jaipur-302004
Jaipur
RAJASTHAN |
9887870552
draagarwal16@gmail.com |
| Dr Mukesh Kalla |
SR Kalla Memorial Gastro & General Hospital |
78-79 Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C- Scheme, Jaipur, Rajasthan, 302001 India
Jaipur
RAJASTHAN |
9829050622
drmkalla@rediff.com |
| Dr Murugesh M |
Sri Ramakrishna Hospital |
No.395, Sarojini Naidu Road, Balasundaram Layout, B.K.R Nagar, Coimbatore, Tamil Nadu 641044, India
Coimbatore
TAMIL NADU |
7736020004
departmentstartup@gmail.com |
| Dr Rajiv Manhar Mehta |
Surat Institute of Digestive Sciences |
Vijay Nagar Gate No-3, Besides Nirman Bhavan, Opposite Gandhi College, Surat-395002, Gujarat, India.
Surat
GUJARAT |
9879863510
rmgastro@yahoo.com |
| Dr Kiran Kumar Peddi |
Yashoda Hospital |
Raj Bhavan Road, Somajiguda, Hyderabad, Telangana - 500082
Hyderabad
TELANGANA |
9966596459
kirankpeddi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee |
Approved |
| Ethics Committee |
Approved |
| IEC, Fortis Memorial Research Institute |
Approved |
| Institute Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Amrita Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee MAMC Maulana Azad Medical College |
Approved |
| Institutional Ethics Committee, KLE University |
Submittted/Under Review |
| SR Kalla Memorial Ethical Committee For Human Research |
Approved |
| Sri Ramakrishna Hospital Ethical Committee |
Approved |
| Surat Institute of digestive sciences EC |
Approved |
| Yashoda Academy of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K509||Crohns disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ozanimod |
Ozanimod 0.92 mg/day
(Equivalent to ozanimod HCl 1 mg) From Day 1 to week234. A total duration 234 weeks. OD |
| Comparator Agent |
Placebo |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are not in clinical response and/or clinical remission after completing 12 weeks in the Induction Study RPC01-3201,
2. Subjects who experience relapse in the Maintenance Study RPC01-3203, subjects who complete the Maintenance Study RPC01-3203.
3. Female subjects of child bearing potential. Must agree to practice a highly effective method of contraception throughout the study until completion.
|
|
| ExclusionCriteria |
| Details |
1. Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
2. Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
3. Is receiving treatment with any of the following drugs or interventions within the CYP2C8 inhibitors, inducers and Monoamine oxidase inhibitors Other protocol-defined inclusion/exclusion criteria apply. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of Subjects with a CDAI score of less than 150 |
Subjects will be evaluated Annually for Up to 234 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50% |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with average daily abdominal pain score ≤ 1 point, & average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of 150 |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with CDAI reduction from baseline of ≥ 70 points |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Change from baseline in CDAI |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of 150 & SES-CD decrease from baseline of ≥ 50% |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with CDAI score of 150 & SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with average daily abdominal pain score ≤ 1 point & average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with SES-CD ≤ 4 points & a SES-CD decrease ≥ 2 points |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with a CDAI score 150 in participants off corticosteroids |
Subjects will be evaluated Annually for Up to 234 Weeks. |
| Proportion of participants with a Crohns Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% |
Subjects will be evaluated Annually for Up to 234 Weeks. |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "854"
Final Enrollment numbers achieved (India)="8" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2023 |
| Date of Study Completion (India) |
26/10/2024 |
| Date of First Enrollment (Global) |
14/11/2018 |
| Date of Study Completion (Global) |
31/10/2024 |
|
Estimated Duration of Trial
|
Years="6"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Phase 3, open-label, multicenter extension study to evaluate safety and explore the long-term efficacy of ozanimod in subjects with moderately to severely active CD. It is anticipated that approximately 1200 subjects who have participated in a prior study of ozanimod for CD will be eligible to participate in this study if they meet the eligibility criteria and have not met the discontinuation criteria as outlined in the prior studies (RPC01-3201, RPC01-3203). |