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Not yet recruiting NCT07403487

Phase II Trial of RC1416 Injection in Asthma

Phase II Interventional Moderate to Severe Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RC1416, RC1416 Placebo.
Who it may be relevant to
Registry conditions: Moderate to Severe Asthma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

RC1416 is a bispecific homodimer nanobody .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 195 severe uncontrolled asthma subjects will be enrolled in three groups to access the efficacy and safety of RC1416.

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 outcome measures

  • Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1) [Time frame: During 32 weeks]
Secondary outcome measures (12)
  • Severe asthma exacerbation [Time frame: During 32 weeks]
  • Pre-BD FEV1 [Time frame: During 32 weeks]
  • Morning and evening peak expiratory flow (PEF) [Time frame: During 32 weeks]
  • forced vital capacity (FVC) [Time frame: During 32 weeks]
  • Forced mid-expiratory flow (FEF25-75%) before bronchodilator (BD) [Time frame: During 32 weeks]
  • Asthma loss of control (LOAC) [Time frame: During 32 weeks]
  • Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit [Time frame: During 32 weeks]
  • Asthma Control Questionnaire-6 (ACQ-6) score [Time frame: During 32 weeks]
  • Asthma Quality of Life Questionnaire (AQLQ-S) score [Time frame: During 32 weeks]
  • weekly Asthma Symptom Diary (ASD) score [Time frame: During 32 weeks]
  • Rescue medication [Time frame: During 32 weeks]
  • Adverse Events [Time frame: During 32 weeks]

Eligibility criteria

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 45 centers
  • Wanbei Coal-Electricity Group General Hospital — Suzhou
  • China-Japan Friendship Hospital — Beijing
  • Gansu Provincial People's Hospital — Lanzhou
  • Qingyuan People's Hospital — Qingyuan
  • Liuzhou Workers' Hospital — Liuzhou
  • The Third Hospital of Hebei Medical University — Shijiazhuang
  • The Affiliated Hospital of North China University of Science and Technology — Tangshan
  • Xingtai People's Hospital — Xingtai
  • … and 37 more centers

Identifiers

NCT: NCT07403487 · RJK-RC1416-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗