Phase II Trial of RC1416 Injection in Asthma

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Asthma

In brief

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.

Key facts

Study ID

NCT07403487

Run by

Nanjing RegeneCore Biotech Co., Ltd.

People needed

195

Starts

2026-03-10

Expected to finish

2028-02-28

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Wanbei Coal-Electricity Group General Hospital — Suzhou, Anhui, China
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China
• Gansu Provincial People's Hospital — Lanzhou, Gansu, China
• Qingyuan People's Hospital — Qingyuan, Guangdong, China
• Liuzhou Workers' Hospital — Liuzhou, Guangxi, China
• The Third Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• The Affiliated Hospital of North China University of Science and Technology — Tangshan, Hebei, China
• Xingtai People's Hospital — Xingtai, Hebei, China
• The First Affiliated Hospital of Hebei North University — Zhangjiakou, Hebei, China
• Daqing Oilfield General Hospital — Daqing, Heilongjiang, China
• The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine — Harbin, Heilongjiang, China
• The Third Affiliated Hospital of Qiqihar Medical University — Qiqihar, Heilongjiang, China
• Anyang People's Hospital — Anyang, Henan, China
• The First Affiliated Hospital of Henan University — Kaifeng, Henan, China
• Sanmenxia Central Hospital — Sanmenxia, Henan, China
• Xinxiang First People's Hospital — Xinxiang, Henan, China
• Yichang Central People's Hospital — Yichang, Hubei, China
• Hunan Provincial People's Hospital — Changsha, Hunan, China
• Nanjing Jiangning Hospital — Nanjing, Jiangsu, China
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
• Yangzhou First People's Hospital — Yangzhou, Jiangsu, China
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• The First Hospital of Jilin University — Changchun, Jilin, China
• Jilin Central Hospital — Jilin City, Jilin, China

Full record on ClinicalTrials.gov

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