Phase II Trial of RC1416 Injection in Asthma
ConditionModerate to Severe Asthma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing RegeneCore Biotech Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RC1416
- RC1416 Placebo
Treatment groups
195 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov