臨床研究等提出・公開システム

A randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to assess the efficacy, safety, and tolerability of subcutaneous lunsekimig (SAR443765) in adult participants with moderate-to-severe asthma

Dose ranging study of lunsekimig (SAR443765) compared with placebo-control in adult participants with moderate to severe asthma
(AIRCULES)

Obara Kentaro

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

clinical-trials-jp@sanofi.com

Clinical Study Unit

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

+81-3-6301-3670

clinical-trials-jp@sanofi.com

Not Recruiting

Feb. 05, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- A physician-diagnosed moderate-to-severe asthma for >=12 months based on Global Initiative for Asthma (GINA) guidelines Steps 4 and 5.
- Participants with existing treatment with moderate-to-high doses of inhaled corticosteroid (ICS) therapy in combination with at least 1 but no more than 2 additional controller medications for 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.
- Asthma control questionnaire (ACQ) -5 score more than 1.5 at Screening (Visit 1).

Participants are excluded from the study if any of the following criteria apply:
- Chronic obstructive or other lung diseases (eg, chronic obstructive pulmonary disease [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 oral corticosteroid (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-Guerin (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.

Both

Asthma

Drug: Lunsekimig
Pharmaceutical form: solution for injection, Route of administration: subcutaneous
Drug: Placebo
Pharmaceutical form: solution for injection, Route of administration: subcutaneous

Arm description
- Experimental: Lunsekimig Dose 1 interval 1
Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1
- Experimental: Lunsekimig Dose 1 interval 2
Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2
- Experimental: Lunsekimig Dose 2 interval 1
Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1
- Experimental: Lunsekimig Dose 2 interval 2
Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2
- Placebo Comparator: Placebo
Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2

1. Annualized rate of asthma exacerbation events
[Time frame: From baseline to week 48]

1. Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
[Time frame: From baseline to week 48]
2. Change from baseline in post-BD FEV1
[Time frame: From baseline to week 48]
3. The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)
[Time frame: From baseline to week 48]
4. 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.
5. Change from baseline in ACQ-5 score
[Time frame: From baseline to week 48]
6. Change from baseline in fraction of exhaled nitric oxide (FeNO)
[Time frame: From baseline to week 48]
7. Time to first asthma exacerbation
[Time frame: From baseline to week 48]
8. Annualized rate of loss asthma exacerbations requiring hospitalization or emergency room or urgent care visit
[Time frame: From baseline to week 48]
9. Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief
[Time frame: From baseline to week 48]
10. 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.
11. Proportion of participants with >=4-point improvement in SGRQ score
[Time frame for evaluation: From baseline to week 48]
12. Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores
[Time frame: From baseline to week 48]
13. Proportion of participants with >=0.5-point improvement in AQLQ(S)+12 domain and total scores
[Time frame for evaluation: From baseline to week 48]
14. Change from baseline in ACQ scores
[Time frame: From baseline to week 48]
15. Proportion of participants with >=0.5-point reduction in ACQ-6 and ACQ-7 score
[Time frame for evaluation: From baseline to week 48]
16. Serum lunsekimig concentrations
[Time frame: From baseline to week 52]
17. Anti-drug antibodies (ADA) against lunsekimig
[Time frame: From baseline to week 52]
18. Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events
[Time frame: From baseline to week 52]

+81-3-5712-5087

Nov. 15, 2023

Yes

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

United States/Argentina/Brazil/Canada/Chile/China/India/Israel/Republic of Korea/Mexico/South Africa/Turkey/United Kingdom