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CTRI Number  CTRI/2024/06/069046 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 29/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A study to assess the long-term safety and tolerability of itepekimab in patients with chronic obstructive pulmonary disease (COPD) 
Scientific Title of Study   A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in patients with chronic obstructive pulmonary disease (COPD) who participated in either EFC16750 or EFC16819 clinical studies 
Trial Acronym  Aerify 4 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
134401 IND  Other 
2023-508085-15  EudraCT 
LTS18133 Protocol amendment 01, version 1 dated 29 Mar 2024  Protocol Number 
 
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 Godhuli Chatterjee 
Designation  Senior Medical Advisor 
Affiliation  Sanofi Healthcare India Private Limited 
Address  Sanofi House, L&T Business Park, Saki-Vihar Road, Powai

Mumbai
MAHARASHTRA
400072
India 
Phone  9930151289  
Fax    
Email  godhuli.chatterjee@sanofi.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Amit Verma 
Designation  Clinical Project Leader 
Affiliation  Sanofi Healthcare India Private Limited 
Address  Sanofi House, L&T Business Park, Saki-Vihar Road, Powai

Mumbai
MAHARASHTRA
400072
India 
Phone  7897180085  
Fax    
Email  amit.verma2@sanofi.com  
 
Source of Monetary or Material Support  
Sanofi Healthcare India Pvt. Ltd, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai Mumbai:400072 
 
Primary Sponsor  
Name  Sanofi Healthcare India Pvt Limited 
Address  Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai Mumbai:400072 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
Bulgaria
Canada
Chile
China
Estonia
France
Georgia
Germany
Greece
Hungary
India
Israel
Italy
Japan
Poland
Portugal
Republic of Korea
Romania
South Africa
Turkey
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Katiyar  Apollo Specialty Hospital Pvt Ltd  Room No. B-14, Basement of Apollo Specialty Hospital Pvt Ltd, 14/138, Chunni Ganj, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH 		 9889888080

skkatiyarin@gmail.com 
Dr Sharad Tikkiwal  Asthma Bhawan  Research Division, Basement of Asthma Bhawan, R-3, Sector-6, Vidhyadhar Nagar, Jaipur-302039
Jaipur
RAJASTHAN 		 9828027022

sharadtikkiwal@gmail.com 
Dr Vivek Gupta  Criticare Hospital and Research Institute  4th Floor, Dhanshree Complex, Near Hotel Hardeo, Sitabuldi, Nagpur– 440012
Nagpur
MAHARASHTRA 		 9373115548

vivekurvashi@yahoo.com 
Dr Kozhi Parambathu Suraj  Institute of Chest Diseases, Government Medical College, Kozhikode  Room No.10, 1st Floor Department of Pulmonary Medicine, Institute of Chest Disease,Kozhikode, Kerala - 673008
Kozhikode
KERALA 		 9447445135

drsurajkp@yahoo.com 
Dr Rajkumar Nikalje  Lifepoint Multispecialty Hospital  3rd Floor, Lifepoint Research Unit, 145/1, Mumbai Bangalore highway, Near Hotel Sayaji, Wakad, Pune-411057
Pune
MAHARASHTRA 		 9028560535

rajnikalje80@gmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  B-11, Clinical Research Department,Central Spine, Agrasen Aspatal Marg, Sector -7 Vidyadhar Nagar, Jaipur-302039
Jaipur
RAJASTHAN 		 9414414834

Doctormanishjain2@gmail.com 
Dr Vinit Niranjane  Orange City Hospital & Research Institute  1st Floor, Shyam Building, 19, Pandey Layout, Veer Sawarkar Square, Nagpur-440015
Nagpur
MAHARASHTRA 		 9923701980

vinit.niranjane@gmail.com 
Dr Sahajal Dhooria  Post Graduate Institute of Medical Education and Research (PGIMER)  Level 2, Dept of Pulmonary Medicine, Nehru Hospital Building, Sector-12, Chandigarh-160012
Chandigarh
CHANDIGARH 		 9530661388

sahajal@gmail.com 
Dr Gautam Moharil  Respira Chest and Critical Care  5th Floor, Plot No 5, Shree radhey Health Heights, Central Bazar Road, Ramdaspeth, Nagpur 440010
Nagpur
MAHARASHTRA 		 9975396515

gautam.moharil@gmail.com 
Dr Gautam Moharil  Respira Chest and Critical Care, Nagpur  5th Floor, Plot no. 5, Shree Radhey Health Heights, Central Bazar Road, Ramdaspeth, Nagpur-44001
Nagpur
MAHARASHTRA 		 9975396515

gautam.moharil@gmail.com 
Dr Akash Balki  Shree Hospital and Critical Care center  3rd Floor, 799, Om Nagar Opp. Tajshree Building Sakkardara Square Nagpur-440009
Nagpur
MAHARASHTRA 		 9890812215

akashbalki49@gmail.com 
Dr Abhinandan Mutha  Siddhi Hospital  Ground Floor, Clinical Research Room, C/O, Dr Mutha Hospital, P-67, MIDC, Satpur, Behind ITI, Near PF Office, Trimbak Road,Satpur, Nashik 422007
Nashik
MAHARASHTRA 		 9850767069

abhimutha@gmail.com 
Dr Venkata Nagarjuna Maturu  Yashoda Hospital  Clinical Research dept, 1st Floor, Hitech City, Hyderabad, Telangana.500084
Hyderabad
TELANGANA 		 9100935638

arjunjipmer@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Apollo Specialty Hospital Kanpur Ethics Committee  Approved 
Criticare Hospital Ethics Committee, Nagpur  Approved 
IEC Maharaja Agrasen Hospital, Jaipur  Approved 
IEC_Rughwani Childcare centre and Hospital, Nagpur  Approved 
Institutional Ethics Committee Asthma Bhawan  Approved 
Institutional Ethics Committee, GMC,Kozhikode, Kerala  Approved 
Institutional Ethics Committee, PGIMER, Chandogarh  Approved 
Institutional Ethics Committee, Yashoda Hospital, Secunderabad-  Approved 
lnstitutional Ethics Committee- Rhughwani Child Care center and Hospital, Nagpur  Approved 
LPR Ethics Committee, Lifepoint Multispeciality Hospital, Pune  Approved 
Orange City Hospital & Institutional Ethics Committee  Approved 
Shree Hospital Ethics Committee,Nagpur  Approved 
Siddhi Hospital Institutional Ethics Committee (SHIEC}  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Itepekimab  Dose formulation: prefilled syringe Unit dose strength(s) 150 mg/mL Route of Administration: SC injection Total duration - 52 weeks 
Comparator Agent  Placebo matching itepekimab  Administered as a single SC injection of matching placebo to itepekimab Q2W Total duration - 52 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  - 01. Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an EoT visit occurred no later than 3 days before the enrolment visit of this study.
- 02- signed ICF
- 03- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
--a) Male participants: No contraceptive measures required for this study
--b) Female participants: Contraceptive use by WOCBP should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies.
--- Not a WOCBP as defined in appendix 4 of protocol or
--- A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the intervention period and for at least 20 weeks after the last dose of study intervention.
- 04-  
 
ExclusionCriteria 
Details  -01- Pregnancy during parent study.
-02- Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin.
-03- Any opportunistic infection during the parent study, such as TB or other infections whose nature or course may suggest an immunocompromised status.
-04- Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study.
-05- Serum ALT more than 3 x upper limit of normal (ULN) and total bilirubin more than 2 x ULN during the parent study.
-06- Serum ALT more than 5 x ULN if baseline ALT less than equal to 2 x ULN or ALT more than 8 x ULN if baseline ALT more than 2 x ULN during the parent study.
-07- Any other situation that led to a permanent premature IMP discontinuation in parent trials
-08- Individuals accommodated in an institution because of regulatory or legal order, prisoners or participants who are legally institutionalized.
-09- Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. Any other clinically significant change in the participants medical condition that may affect the participants safety as a result of participation in this extension study in the judgment of the Investigator. In case of doubt, please liaise with the sponsor 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate the long-term safety and tolerability of itepekimab in participants with moderate-to-severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)  Week 0, and Week 72 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the PK profile of itepekimab in participants with moderate-to-severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)  Week 0, week 24, week 52 and Week 72 
Evaluate immunogenicity to itepekimab in participants with moderate-to-severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)  Week 0, week 24, week 52 and Week 72 
Evaluate the long-term efficacy of itepekimab through various endpoints in participants with moderate-to-severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)  Week 0 to Week 52 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="80" 
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)   17/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 parallel, double-blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments.

The primary purpose of this study is to evaluate safety and tolerability of both itepekimab 300 mg SC Q2W or itepekimab 300 mg SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. 
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