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Phase II Trial of RC1416 Injection in Asthma

ConditionModerate to Severe Asthma
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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 week prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RC1416

    Drug

    There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.

  • RC1416 Placebo

    Drug

    Each subjects will receive the placebo by subcutaneous injection

Treatment groups

195 Participants
are divided into 2 treatment groups
Group A: RC1416Experimental treatment 1 intervention
Group B: RC1416 PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)

Time frame
During 32 weeks

Secondary outcomes

1

Severe asthma exacerbation

Severe asthma exacerbation events, Time to the first asthma exacerbation

Time frame
During 32 weeks
2

Pre-BD FEV1

Time frame
During 32 weeks
3

Morning and evening peak expiratory flow (PEF)

Mean change from baseline of absolute value and percentage

Time frame
During 32 weeks
4

forced vital capacity (FVC)

Mean change from baseline of absolute value and percentage

Time frame
During 32 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing RegeneCore Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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