Recruiting
Phase II Trial of RC1416 Injection in Asthma
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.
ClinicalTrials.gov IDNCT07403487
PhasePHASE2
Enrollment195
SponsorNanjing RegeneCore Biotech Co., Ltd.
Age18 Years
SexALL
Conditions studied
Moderate to Severe Asthma
About this study
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.
Interventions
- Drug: RC1416 — There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
- Drug: RC1416 Placebo — Each subjects will receive the placebo by subcutaneous injection
Primary outcomes
- Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1) (During 32 weeks)
Eligibility information
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 week 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
Study locations
- Anqiing Municipal Hospital, Anqing, Anhui 246004 China
- Wanbei Coal-Electricity Group General Hospital, Suzhou, Anhui 234000 China
- China-Japan Friendship Hospital, Beijing, Beijing Municipality 100029 China
- The Affiliated Yongchuan Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality 402160 China
- Gansu Provincial People's Hospital, Lanzhou, Gansu 730000 China
- The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei 050051 China
- The Affiliated Hospital of North China University of Science and Technology, Tangshan, Hebei 063000 China
- Xingtai People's Hospital, Xingtai, Hebei 054001 China
- The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei 075000 China
- Daqing Oilfield General Hospital, Daqing, Heilongjiang 163001 China
Showing 10 of 44 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.