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

JRCT ID: jRCT2031230533

Registered date:25/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 05/02/2024
• Target sample size: 630
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

Drug: SAR443765
Pharmaceutical form: solution for injection, Route of administration: subcutaneous
Drug: Placebo
Pharmaceutical form: solution for injection, Route of administration: subcutaneous

Arm description
- Experimental: SAR443765 Dose 1 interval 1
Participants will receive Dose 1 of SAR443765 (subcutaneous injection) according to established dosing interval 1
- Experimental: SAR443765 Dose 1 interval 2
Participants will receive Dose 1 of SAR443765 (subcutaneous injection) according to established dosing interval 2
- Experimental: SAR443765 Dose 2 interval 1
Participants will receive Dose 2 of SAR443765 (subcutaneous injection) according to established dosing interval 1
- Experimental: SAR443765 Dose 2 interval 2
Participants will receive Dose 2 of SAR443765 (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

Outcome(s)

Primary Outcome

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

Secondary Outcome

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 of asthma control events (LOAC) events
[Time frame: From baseline to week 48]
9. Time to first LOAC event
[Time frame: From baseline to week 48]
10. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit
[Time frame: From baseline to week 48]
11. Average number of inhalations per day of short-acting beta 2-agonist (SABA) or Low dose ICS/formoterol for symptom relief
[Time frame: From baseline to week 48]
12. 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.
13. Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ[S]) scores
[Time frame: From baseline to week 48]
14. Change from baseline in ACQ scores
[Time frame: From baseline to week 48]
15. Serum SAR443765 concentrations
[Time frame: From baseline to week 48]
16. Anti-drug antibodies (ADA) against SAR443765
[Time frame: From baseline to week 48]
17. 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 48]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

- 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).

Exclude criteria

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.

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT06102005,023-503712-33