RC1416 shots for moderate to severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II interventional study evaluating the safety and efficacy of RC1416, a bispecific nanobody, in adults with moderate to severe asthma that remains uncontrolled despite inhaled corticosteroid therapy. Participants are enrolled into three groups to assess different dosing or regimens, including RC1416 and placebo. The trial measures respiratory function, symptom control, and safety over a defined period. Eligible adults have documented asthma, a reduced FEV1, frequent symptoms, and a history of recent severe exacerbations. Exclusions include known allergy to RC1416 or related components and coexisting lung diseases such as COPD.

Why it matters

Who can join: the full rules

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

Where it's running

• Wanbei Coal-Electricity Group General Hospital
  Suzhou, Anhui, China Recruiting
• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• The Affiliated Yongchuan Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Gansu Provincial People's Hospital
  Lanzhou, Gansu, China Recruiting
• The Third Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• The Affiliated Hospital of North China University of Science and Technology
  Tangshan, Hebei, China Recruiting

Study contacts

• Study coordinator: Guo Qian
• Email: guoqian@regenecore.com
• Phone: +86-025-58608860

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.