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Phase II Study of RC1416 Injection in COPD

ConditionModerate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorNanjing RegeneCore Biotech Co., Ltd.

About this trial

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.

Body Mass Index (BMI) ≥ 16 kg/m².

Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a history of COPD for ≥ 12 months at screening.

Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) < 0.7, and post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted value at screening.

Disqualifiers

A current diagnosis of asthma or a history of asthma.

Presence of other significant pulmonary diseases except COPD as judged by the Investigator.

History of malignancy .

A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to signing the informed consent form.

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

180 Participants
are divided into 2 treatment groups
Group A: RC1416 InjectionExperimental treatment 1 intervention
Group B: Placebo ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

moderate or severe COPD exacerbations (AECOPD) and forced expiratory volume in 1 Second (FEV1)

Evaluate the annualized rate of AECOPD and the change in FEV1 from baseline

Time frame
During 52 weeks

Secondary outcomes

1

The safety and tolerability

Adverse events, laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examinations.

Time frame
During 52 weeks
2

pharmacokinetic

Css, DF, Tmax.

Time frame
During 52 weeks
3

immunogenicity

ADA positivity rate and titer, and NAb positivity rate.

Time frame
During 52 weeks
4

biomarkers predictive of the efficacy

FeNO, total IgE, eosinophil count, and TARC levels.

Time frame
During 52 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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