Phase II Trial of RC1416 Injection in Asthma
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of RC1416 Injection in Adult Patients With Moderate to Severe Asthma
1 other identifier
interventional
195
1 country
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
March 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
September 10, 2026
September 1, 2026
1.6 years
January 27, 2026
September 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)
Mean change from baseline in Pre-BD forced expiratory volume in 1 Second (FEV1)
During 32 weeks
Secondary Outcomes (15)
Severe asthma exacerbation
During 32 weeks
Pre-BD FEV1
During 32 weeks
Morning and evening peak expiratory flow (PEF)
During 32 weeks
forced vital capacity (FVC)
During 32 weeks
Forced mid-expiratory flow (FEF25-75%) before bronchodilator (BD)
During 32 weeks
- +10 more secondary outcomes
Study Arms (2)
RC1416
EXPERIMENTALRC1416 Placebo
PLACEBO COMPARATORInterventions
There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
Eligibility Criteria
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
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
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150001, China
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, 161000, China
Anyang People's Hospital
Anyang, Henan, 455000, China
The First Affiliated Hospital of Henan University
Kaifeng, Henan, 475000, China
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000, China
Xinxiang First People's Hospital
Xinxiang, Henan, 453000, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
Huhhot First Hospital
Hohhot, Inner Mongolia, 010020, China
The Affiliated Hospital of Inner Mongolia
Hohhot, Inner Mongolia, 010030, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
Xuzhou Mining Group General Hospital
Xuzhou, Jiangsu, 221006, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Jilin Central Hospital
Jilin City, Jilin, 132011, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110031, China
Ningxia Hui Autonomous Region People's Hospital
Yinchuan, Ningxia, 750002, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710100, China
Heze Municipal Hospital
Heze, Shandong, 274031, China
Qilu Second Hospital of Shandong University
Jinan, Shandong, 250022, China
The Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Zibo Central Hospital
Zibo, Shandong, 255036, China
Shanghai Pulmonary Hospital (Tongji University Affiliated Shanghai Pulmonary Hospital)
Shanghai, Shanghai Municipality, 200433, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000, China
Chengdu Third People's Hospital
Chengdu, Sichuan, 610031, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130, China
Mianyang Central Hospital
Mianyang, Sichuan, 621000, China
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2026
First Posted
February 11, 2026
Study Start
March 10, 2026
Primary Completion (Estimated)
October 25, 2027
Study Completion (Estimated)
February 28, 2028
Last Updated
September 10, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share