Under construction – not a live service
Sign in
Taking people in ChinaPhase 2

Tests RC1416 injection in adults with moderate to severe asthma

Tests RC1416 injection against placebo in adults with moderate to severe asthma.

Plain-language title generated from the registry record
Registry title: Phase II Trial of RC1416 Injection in Asthma

Key facts

Where
Anqing, Anyang, Beijing, Changchun, Chengdu, Chongqing, Daqing, Hangzhou, Harbin, Heze, Hohhot, Jilin City, Jinan, Jining, Kaifeng, Lanzhou, Mianyang, Nanchang, Nanjing, Ningbo, Qingdao, Qiqihar, Sanmenxia, Shanghai, Shenyang, Shijiazhuang, Suzhou, Tangshan, Wenzhou, Xi'an, Xingtai, Xinxiang, Xuzhou, Yantai, Yichang, Yinchuan, Yuncheng, Zhangjiakou, and Zibo, ChinaSee the 44 sites
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT07403487, who can take part

Where in China

  • Anqiing Municipal HospitalAnqing, ChinaNot yet recruiting
  • Anyang People's HospitalAnyang, ChinaTaking people
  • China-Japan Friendship HospitalBeijing, ChinaTaking people
  • The First Hospital of Jilin UniversityChangchun, ChinaTaking people
  • Chengdu Fifth People's HospitalChengdu, ChinaTaking people
  • Chengdu Third People's HospitalChengdu, ChinaTaking people
  • The Affiliated Yongchuan Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
  • Daqing Oilfield General HospitalDaqing, ChinaTaking people
  • Affiliated Hangzhou First People's HospitalHangzhou, ChinaTaking people
  • The Second Affiliated Hospital of Heilongjiang University of Chinese MedicineHarbin, ChinaTaking people
  • Heze Municipal HospitalHeze, ChinaTaking people
  • Huhhot First HospitalHohhot, ChinaNot yet recruiting
  • The Affiliated Hospital of Inner MongoliaHohhot, ChinaNot yet recruiting
  • Jilin Central HospitalJilin City, ChinaTaking people
  • Qilu Second Hospital of Shandong UniversityJinan, ChinaTaking people
  • The Affiliated Hospital of Jining Medical UniversityJining, ChinaTaking people
  • The First Affiliated Hospital of Henan UniversityKaifeng, ChinaTaking people
  • Gansu Provincial People's HospitalLanzhou, ChinaTaking people
  • Mianyang Central HospitalMianyang, ChinaTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
  • Nanjing Jiangning HospitalNanjing, ChinaTaking people
  • The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
  • QingDao Municipal HospitalQingdao, ChinaTaking people
  • The Third Affiliated Hospital of Qiqihar Medical UniversityQiqihar, ChinaTaking people
  • Sanmenxia Central HospitalSanmenxia, ChinaTaking people
  • Shanghai Pulmonary Hospital (Tongji University Affiliated Shanghai Pulmonary Hospital)Shanghai, ChinaTaking people
  • Shengjing Hospital Of China Medical UniversityShenyang, ChinaTaking people
  • The Fourth Affiliated Hospital of China Medical UniversityShenyang, ChinaTaking people
  • The Third Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
  • Wanbei Coal-Electricity Group General HospitalSuzhou, ChinaTaking people
  • The Affiliated Hospital of North China University of Science and TechnologyTangshan, ChinaTaking people
  • The Second Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
  • Xi'an International Medical Center HospitalXi'an, ChinaTaking people
  • Xingtai People's HospitalXingtai, ChinaTaking people
  • Xinxiang First People's HospitalXinxiang, ChinaTaking people
  • The affiliated hospital of xuzhou medical universityXuzhou, ChinaTaking people
  • Xuzhou Central HospitalXuzhou, ChinaTaking people
  • Xuzhou Mining Group General HospitalXuzhou, ChinaTaking people
  • Yantai Yuhuangding HospitalYantai, ChinaTaking people
  • Yichang Central People's HospitalYichang, ChinaTaking people
  • Ningxia Hui Autonomous Region People's HospitalYinchuan, ChinaTaking people
  • Yuncheng Central HospitalYuncheng, ChinaTaking people
  • The First Affiliated Hospital of Hebei North UniversityZhangjiakou, ChinaTaking people
  • Zibo Central hospitalZibo, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Nanjing RegeneCore Biotech Co., Ltd.
Trial code
NCT07403487
Record updated
10 September 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Individuals with a known history of allergy to the investigational product or its excipients; 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; Used biologic/systemic immunosuppressant/immunomodulators within 12 weeks or 5 half-lives prior to screening; Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function ; With a history of malignancy within the past 5 years ; Active or incompletely treated tuberculosis; 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.

ClinicalTrials.gov NCT07403487