CTRI/2024/01/061384招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 630
- 试验地点
- 8
- 主要终点
- Annualized rate of asthma exacerbation events over a period of 48 weeks, SAR443765 compared to placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
- •Physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA definition Step 4 and
- •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
- •â‰¥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.
- •Participants with pre-BD FEV1 of 40% to 80% (inclusive) of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1).
- •ACQ-5 score >1.5 at Screening (Visit 1).
- •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).
- •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).
- •Body mass index (BMI) within the range 18.5 to 40 kg/m2 (inclusive).
- •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.
排除标准
- •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.
- •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.
- •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).
- •Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
- •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.
- •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.
- •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.
- •Active/chronic helminthic infection
- •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).
- •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.
结局指标
主要结局
Annualized rate of asthma exacerbation events over a period of 48 weeks, SAR443765 compared to placebo
时间窗: 48 weeks
次要结局
- Change from baseline in pre-BD FEV1 at Week 48(-Serum SAR443765 concentrations measured throughout the study)
研究者
研究点 (8)
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