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Phase II Trial of RC1416 Injection in Asthma

Not Yet RecruitingPhase 2

Sponsor: Nanjing RegeneCore Biotech Co., Ltd.

Conditions: Moderate to Severe Asthma

Interventions: RC1416, RC1416 Placebo

Countries: China

This study is a phase II study of RC1416 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of RC1416 in subjects with severe uncontrolled asthma.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female aged 18 and 75 years.
* Diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of the 2024 GINA guidelines.
* Have received medium-to-high dose ICS therapy for at least 3 consecutive months prior to screening, and maintained a stable treatment regimen and dose for ≥1 month prior to baseline.
* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) measurement ≤80% of the predicted normal value at both the screening and baseline visits.
* Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5 at both the screening and baseline visits.
* Must have experienced ≥1 severe asthma exacerbation event within the 12 months prior to screening.
* Positive bronchodilator reversibility test.

Exclusion Criteria:

* Individuals with a known history of allergy to the investigational product or its excipients.
* Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function .
* Experienced a severe asthma exacerbation event from within 1 month prior to screening until before dosing.
* Used systemic corticosteroids within 1 month prior to screening.
* Had a pulmonary or other site infection requiring intravenous antibiotics, antifungals, or antivirals from within 1 month prior to screening until before dosing.
* Used traditional Chinese medicine with anti-asthmatic effects within 1 month prior to screening.
* Underwent major surgery within 8 weeks prior to screening or plans to undergo major surgery during the study period.
* With a history of malignancy within the past 5 years .
* Active or incompletely treated tuberculosis
* Used biologic/systemic immunosuppressant/immunomodulators within 12 weeks or 5 half-lives prior to screening.
* Diagnosed active parasitic infection; suspected parasitic infection or high risk of infection.
* Abnormal 12-lead electrocardiogram (ECG) at screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Locations (45)

Suzhou, Anhui, China
Beijing, Beijing Municipality, China
Lanzhou, Gansu, China
Qingyuan, Guangdong, China
Liuzhou, Guangxi, China
Shijiazhuang, Hebei, China
Tangshan, Hebei, China
Xingtai, Hebei, China
Zhangjiakou, Hebei, China
Daqing, Heilongjiang, China
Harbin, Heilongjiang, China
Qiqihar, Heilongjiang, China
Anyang, Henan, China
Kaifeng, Henan, China
Sanmenxia, Henan, China
Xinxiang, Henan, China
Yichang, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Xuzhou, Jiangsu, China
Yangzhou, Jiangsu, China
Ganzhou, Jiangxi, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Jilin City, Jilin, China
Tonghua, Jilin, China
Shenyang, Liaoning, China
Yinchuan, Ningxia, China
Xi'an, Shaanxi, China
Heze, Shandong, China
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