A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma

Recruiting Phase 3 Interventional Study
Moderate to Severe Asthma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
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About This Trial
This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma. The study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Understand the study and voluntarily sign the informed consent form. 2. Age ≥18 and ≤80 years old, male or female, weight ≥40 kg. 3. The subject has been diagnosed with asthma for at least 1 year. 4. Pre-bronchodilator FEV1 measured ≤80% of the normal predicted value. 5. A po…
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Clinical Trials Information Group officer

031169085587

ctr-contact@cspc.cn

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