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CTRI Number  CTRI/2024/01/061384 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 23/07/2026
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 clinical trial to assess the efficacy, safety and tolerability of subcutaneous SAR443765 (an investigational study drug) in patients with moderate to severe asthma 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of subcutaneous SAR443765 in adult participants with moderate to severe asthma 
Trial Acronym  AIRCULES Study 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
DRI16762, PA3, Version number 1, 24-Jun-2025  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 J Dinesh Kumar 
Designation  Medical Advisor 
Affiliation  Sanofi Healthcare India Private Limited  
Address  Sanofi House, L&T Business Park, Saki-Vihar Road, Powai

Mumbai
MAHARASHTRA
400072
India 
Phone  919790753835  
Fax    
Email  DineshKumar.Jeyaprakash@sanofi.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Laxman Deshmukh 
Designation  Clinical Project Leader 
Affiliation  Sanofi Healthcare India Private Limited 
Address  Sanofi House, L&T Business Park, Saki-Vihar Road, Powai, Mumbai, India. Postal Code: 400072
Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai Mumbai
Mumbai
MAHARASHTRA
400072
India 
Phone  09730652540  
Fax    
Email  laxman.deshmukh@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. Ltd 
Address  Sanofi Healthcare India Pvt. Ltd, 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
Belgium
Chile
Czech Republic
India
Israel
Netherlands
Poland
Republic of Korea
Romania
South Africa
Spain
Turkey
United States of America
Brazil
China
Japan
Mexico
Bulgaria
Hungary  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Katiyar  Apollo Specialty Hospital Pvt. Ltd  14/138, Chunni Ganj, Kanpur-208001
Kanpur Nagar
UTTAR PRADESH 		 9889888080

skkatiyarin@gmail.com 
Dr Suraj Kozhi Parambathu  Government Medical College  Institute of Chest Diseases, Government Medical College, Kozhikode Department of Pulmonary Medicine, Institute of Chest Disease, Government Medical College-Kozhikode,
Kozhikode
KERALA 		 9447445135

drsurajkp@yahoo.com 
Dr Srikanth Krishnamoorthy  Hindusthan Hospital  Hindusthan Hospital, 522/3,523/3 Nava India Road, Udaiyampalayam, Coimbatore-641028
Coimbatore
TAMIL NADU 		 9894257706

drsrikanthcbe@gmail.com 
Dr Rajkumar Nikalje  Lifepoint Multispecialty Hospital  145/1, Mumbai Bangalore highway, Near Hotel Sayaji, Wakad, Pune-411057
Pune
MAHARASHTRA 		 9028560535

rajnikalje80@gmail.com 
Dr Bhanu Pratap Singh  Midland Healthcare & Research Center  B-55 & C-42, Mandir Marg, Mahanagar Extension, Lucknow-226 006
Lucknow
UTTAR PRADESH 		 9415011669

bps2159@yahoo.com 
Dr Balki Akash Lataru  Shree Hospital & Critical Care Centre  799, Om Nagar, Opp. Tajshree Building, Sakkardara sq, Nagpur-440009
Nagpur
MAHARASHTRA 		 9890812215

akashbalki49@gmail.com 
Dr Nitesh Gupta  Vardhaman Mahavir Medical College and Safdarjung Hospital  Room No. 638, Dept. of Pulmonary, Critical Care & Sleep Medicine, 6th Floor, Super Specialty Block (SSB), Safdarjung Hospital, Ansari Nagar, New Delhi- 110 029
New Delhi
DELHI 		 9873096364

niteshgupta2107@gmail.com 
Dr Venkata Nagarjuna Maturu  Yashoda Hospitals  Yashoda Healthcare Services Pvt Ltd,Hitech City, Cyber Towers to JNTU Road,Hyderabad-500 084
Hyderabad
TELANGANA 		 9100935638

arjunjipmer@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Apollo Speciality Hospital Kanpur Ethics Committee, Apollo Specialty Hospital Pvt. Ltd., Kanpur  Approved 
IEC for Midland and Research Centre Midland Healthcare And Research Center,  Approved 
Institutional Ethics Committee Govt Medical College Kozhikode 4th Floor, Golden Jubilee Annex Institute of Maternal and Child Health Kozhikode  Approved 
Institutional Ethics Committee VMMC and SJH, VMMC And SAFDARJUNG HOSPITAL  Approved 
Institutional Ethics Committee, Yashoda Academy of Medical Education and Research(IEC-YAMER), Secunderabad  Approved 
Institutional Human Ethics Committee, Hindusthan Hospital,  Approved 
Lifepoint Research- Ethics Committee  Approved 
Shree Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Dose formulation: Solution for injection in vial Unit dose strength(s): 0 mg/2 mL Intervention description: One dose of placebo every 4 weeks for placebo arm and one dose of placebo every 8 weeks for arms SAR443765 60 mg and 300 mg alternating with SAR443765 every 4 weeks. Route of Administration: Subcutaneous injection Treatment duration: 48 weeks  
Intervention  SAR443765  Dose formulation: Solution for injection in vial Unit dose strength(s): 165 mg/1.1 mL Intervention description: One dose of SAR443765 60 mg and 300 mg every 4 weeks and one dose of SAR443765 60 mg and 300 mg every 8 weeks. Route of Administration: Subcutaneous injection Treatment duration: 48 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
2. Physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA definition Step 4 and 5.
3. Participants with existing treatment with moderate-to-high doses of ICS therapy (≥500 μg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 μg/day of fluticasone propionate or clinically comparable (1) in combination with at least 1 but no more than 2 additional controller medications (eg, LABA, LTRA, LAMA, methylxanthines) for at least 3 months with a stable dose ≥1 month prior to Visit 1.
4. ≥1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate-to-high doses of ICS therapy (≥500 μg of fluticasone propionate daily or comparable ICS dosage), and defined as:
- Treatment with systemic corticosteroids (oral or parenteral) for ≥3 days for worsening asthma; in case of a stable maintenance regimen of OCS, at least a doubling of the dose for 3 or more days, OR
- Hospitalization or emergency medical care visit for worsening asthma, requiring systemic corticosteroids.
5. Participants with pre-BD FEV1 of 40% to 80% (inclusive) of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1).
6. ACQ-5 score >1.5 at Screening (Visit 1).
7. Participants with reversibility of at least 12% and 200 mL in FEV1 after administration of up to 8 puffs (800 μg) of albuterol/salbutamol or levalbuterol/levosalbutamol at Screening (Visit 1), or a documented history within 5 years prior to Visit 1 of either positive reversibility testing meeting these criteria or a positive bronchoprovocation test with methacholine, mannitol, histamine, or acetylcholine (per local guidelines for use).
8. If on chronic OCS treatment for the maintenance treatment of asthma, up to a maximum of 15mg prednisone or equivalent daily or 30 mg every other day is allowed, must be on stable dose for ≥1 month prior to Screening (Visit 1).
9. Body mass index (BMI) within the range 18.5 to 40 kg/m2 (inclusive).
10. All 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 Male participants with partners of childbearing potential are eligible to participate if they agree to the following during the study intervention period and until 5 months after the last administration of study intervention or the early termination visit:
• Refrain from donating or cryopreserving sperm PLUS, either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR - Must agree to use contraception/barrier when having sexual intercourse with a WOCBP wh 
 
ExclusionCriteria 
Details  1. Chronic obstructive or other significant lung diseases (eg, COPD [chronic obstructive pulmonary disease], idiopathic pulmonary fibrosis, etc.) which may impair lung function, or another diagnosed pulmonary or systemic disease.
2. Current smoker or former smoker with cessation within 6 months of Screening (Visit 1) or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
3. Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening Visit 1 (counting from the date of completion of treatment for asthma exacerbation).
4. Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
5. Confirmed, symptomatic coronavirus disease 2019 (COVID-19) infection at Screening (Visit 1) or during the screening period; such participants may be re-screened 4 weeks after resolution of symptoms. 6.
6. History of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening (Visit 1); participants who have had a COVID-19 infection prior to Screening who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
7. Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
8. Active/chronic helminthic infection
9. Evidence of acute or chronic infection requiring systemic treatment with antibacterials, antivirals, antifungals, antiparasitics, antimycobacterials, or antiprotozoals within 2 weeks before Visit 1 or during the screening period, significant viral infections within 2 weeks before Visit 1 or during the screening period that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment).
10. For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
11. Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1). Note: TB testing is mandatory to rule out active/latent TB and should be performed, assessed, and documented according to local guidelines. If no local guidelines are available or are not able to be performed at the site, a blood sample for QuantiFERON testing should be sent to the central laboratory. Participants with confirmed positive TB test are excluded from the study unless all of the following conditions are met:
a. have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection, AND
b. have obtained consultation with a specialist to rule out or treat active TB infection, AND
c. for whom review and approval from Sponsor have been granted are eligible.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Annualized rate of asthma exacerbation events over a period of 48 weeks, SAR443765 compared to placebo  48 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in pre-BD FEV1 at Week 48
-Serum SAR443765 concentrations measured throughout the study
- Ant-drug antibodies (ADA) against SAR443765 up to end-of-study.
- Incidence of participants with TEAEs, including local reactions, AESIs and SAEs throughout the study. 		 48 week 
 
Target Sample Size   Total Sample Size="630"
Sample Size from India="45" 
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 2 
Date of First Enrollment (India)   27/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/03/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="2"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 5-arm study for treatment of moderate to severe asthma.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SAR443765 in moderate to severe asthma.

Study details include:

·       The study duration (per participant) will be up to approximately 56 weeks for participants not transitioning into LTS study and will be up to approximately 52 weeks for participants transitioning into LTS study.

·       The randomized treatment duration will be up to approximately 48 weeks.

·       The scheduled number of visits will be 16.

Approximately 630 participants will be randomized to investigational intervention. During this period, participants will continue to take their controller medication(s) used during the screening period and will use an eDiary to record daily use of all controller medications (including any ICS, LABA, LAMA, LTRA, OCS, and methylxanthines). The dose and regimen should not be changed, except for the OCS, for which the dose could be changed per Investigator medical judgement. 
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