Dose Ranging Study of SAR443765 Compared With Placebo-control in Adult Participants With Moderate to Severe Asthma (AIRCULES)

April 11, 2024 updated by: Sanofi

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

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC SAR443765 in adult participants aged 18 to 80 years, (inclusive) with moderate to severe asthma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

630

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free number for US and Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1414AIF
        • Recruiting
        • Investigational Site Number : 0320004
      • San Miguel de Tucuman, Argentina, T4000IAI
        • Recruiting
        • Investigational Site Number : 0320008
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1425BEN
        • Recruiting
        • Investigational Site Number : 0320001
  • Chile
    • Los Ríos
      • Valdivia, Los Ríos, Chile, 5110683
        • Recruiting
        • Investigational Site Number : 1520010
    • Maule
      • Talca, Maule, Chile
        • Recruiting
        • Investigational Site Number : 1520001
    • Reg Metropolitana De Santiago
      • Santiago, Reg Metropolitana De Santiago, Chile, 7580206
        • Recruiting
        • Investigational Site Number : 1520009
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500587
        • Recruiting
        • Investigational Site Number : 1520006
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500692
        • Recruiting
        • Investigational Site Number : 1520005
      • Santiago, Reg Metropolitana De Santiago, Chile, 7750000
        • Recruiting
        • Investigational Site Number : 1520002
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500698
        • Recruiting
        • Investigational Site Number : 1520004
    • Valparaíso
      • Quillota, Valparaíso, Chile, 2260877
        • Recruiting
        • Investigational Site Number : 1520008
      • Viña del Mar, Valparaíso, Chile, 2520598
        • Recruiting
        • Investigational Site Number : 1520011
  • Israel
      • Haifa, Israel, 31048
        • Recruiting
        • Investigational Site Number : 3760001
      • Jerusalem, Israel, 91031
        • Recruiting
        • Investigational Site Number : 3760003
      • Jerusalem, Israel, 91120
        • Recruiting
        • Investigational Site Number : 3760002
      • Ramat Gan, Israel, 5266202
        • Recruiting
        • Investigational Site Number : 3760009
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Investigational Site Number : 3760007
  • Japan
      • Higashiohmi-shi, Japan, 527-8505
        • Recruiting
        • Investigational Site Number : 3920003
    • Kagawa
      • Sakaide-shi, Kagawa, Japan, 762-8550
        • Recruiting
        • Investigational Site Number : 3920002
    • Kyoto
      • Joyo-shi, Kyoto, Japan, 610-0113
        • Recruiting
        • Investigational Site Number : 3920006
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Recruiting
        • Investigational Site Number : 3920011
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Recruiting
        • Investigational Site Number : 3920005
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Investigational Site Number : 4100005
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 05030
        • Recruiting
        • Investigational Site Number : 4100004
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03080
        • Recruiting
        • Investigational Site Number : 4100002
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 138-878
        • Recruiting
        • Investigational Site Number : 4100006
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 120-752
        • Recruiting
        • Investigational Site Number : 4100001
  • Turkey
      • Bursa, Turkey, 16059
        • Recruiting
        • Investigational Site Number : 7920006
      • Istanbul, Turkey, 34303
        • Recruiting
        • Investigational Site Number : 7920002
      • Kayseri, Turkey, 38039
        • Recruiting
        • Investigational Site Number : 7920007
      • Kocaeli, Turkey, 41100
        • Recruiting
        • Investigational Site Number : 7920005
      • Mersin, Turkey, 33070
        • Recruiting
        • Investigational Site Number : 7920001
  • United States
    • Colorado
      • Denver, Colorado, United States, 80219
        • Recruiting
        • Allianz Research Institute Colorado Site Number : 8400026
    • Florida
      • Miami, Florida, United States, 33145
        • Recruiting
        • Clintex Research Group Inc. Site Number : 8400048
      • Miami, Florida, United States, 33186
        • Recruiting
        • New Access Research & Medical Center Site Number : 8400043
      • Miami, Florida, United States, 33186
        • Recruiting
        • Innovations Biotech Site Number : 8400040
      • Miami, Florida, United States, 33184
        • Recruiting
        • High Quality Research Site Number : 8400039
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Deluxe Health Center Site Number : 8400045
      • New Port Richey, Florida, United States, 34653
        • Recruiting
        • Advanced Research Institute, Inc. Site Number : 8400044
      • Pembroke Pines, Florida, United States, 33023
        • Recruiting
        • Pines Care Research Center LLC Site Number : 8400057
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Midwest Clinical Research LLC Site Number : 8400006
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Tryon Medical Research Site Number : 8400029
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Clinical Research of Gastonia Site Number : 8400013
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Recruiting
        • OK Clinical Research, LLC Site Number : 8400021
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Recruiting
        • Allergy and Clinical Immunology Associates Site Number : 8400007
    • Texas
      • Boerne, Texas, United States, 78006
        • Recruiting
        • TTS Research Site Number : 8400010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5
  • Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
  • At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
  • ACQ-5 score more than 1.5 at Screening (Visit 1)

Exclusion Criteria:

  • Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.
  • Current smoker or former smoker with cessation within 6 months of Screening or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
  • 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
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
  • 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).
  • Participants with active tuberculosis (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
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAR443765 Dose1 interval 1
Participants will receive Dose 1 of SAR443765 (subcutaneous injection) according to established dosing interval 1
Drug: SAR443765
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: SAR443765 Dose 1 interval 2
Participants will receive Dose 1 of SAR443765 (subcutaneous injection) according to established dosing interval 2
Drug: SAR443765
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: SAR443765 Dose 2 interval 1
Participants will receive Dose 2 of SAR443765 (subcutaneous injection) according to established dosing interval 1
Drug: SAR443765
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: SAR443765 Dose 2 interval 2
Participants will receive Dose 2 of SAR443765 (subcutaneous injection) according to established dosing interval 2
Drug: SAR443765
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Placebo Comparator: Placebo
Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2
Drug: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized rate of asthma exacerbation events
Time Frame: From baseline to week 48
From baseline to week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pre-bronchodilator (BD) FEV1
Time Frame: From baseline to week 48
From baseline to week 48
Change from baseline in post-BD FEV1
Time Frame: From baseline to week 48
From baseline to week 48
The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)
Time Frame: From baseline to week 48
From baseline to week 48
Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score
Time Frame: From baseline to week 48
ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control
From baseline to week 48
Change from baseline in ACQ-5 score
Time Frame: From baseline to week 48
From baseline to week 48
Change from baseline in FeNO
Time Frame: From baseline to week 48
From baseline to week 48
Time to first asthma exacerbation
Time Frame: From baseline to week 48
From baseline to week 48
Annualized rate of loss of asthma control events (LOAC) events
Time Frame: From baseline to week 48
From baseline to week 48
Time to first LOAC event
Time Frame: From baseline to week 48
From baseline to week 48
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit
Time Frame: From baseline to week 48
From baseline to week 48
Average number of inhalations per day of short-acting beta 2-agoinst (SABA) or Low dose ICS/formoterol for symptom relief
Time Frame: From baseline to week 48
From baseline to week 48
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores
Time Frame: From baseline to week 48
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
From baseline to week 48
Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores
Time Frame: From baseline to week 48
From baseline to week 48
Change from baseline in ACQ scores
Time Frame: From baseline to week 48
From baseline to week 48
Serum SAR443765 concentrations
Time Frame: From baseline to week 48
From baseline to week 48
Anti-drug antibodies (ADA) against SAR443765
Time Frame: From baseline to week 48
From baseline to week 48
Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)
Time Frame: From baseline to week 48
From baseline to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinial Science & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI16762
  • U1111-1280-5514 (Other Identifier: WHO)
  • 2023-503712-33 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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