Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection (NCT07519499) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection
75 participantsStarted 2026-04-01
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, two-stage design, Phase II clinical study. This study is divided into two stages. Stage 1 (Phase IIa) has a dosing duration of 24 weeks (treatment period of 28 weeks) and aims to preliminarily evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD. Stage 2 (Phase IIb) has a dosing duration of 48 weeks (treatment period of 52 weeks) and aims to further evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD.
Who can participate
Age range40 Years β 80 Years
SexALL
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Inclusion criteria
β. The trial participant is able to understand the procedures and methods of this study, is willing to sign the ICF and strictly adhere to the clinical study protocol to complete this study, and can independently complete study-related questionnaires;
β. The trial participant must be aged 40-80 years (inclusive) at the time of signing the ICF, can be either male or female;
β. The trial participant has a BMI β₯16.0 kg/m2;
β. Trial participants diagnosed with COPD for β₯12 months (diagnosed according to GOLD 2024) and meeting the following criteria:
β. Whole blood EOS count β₯150/ΞΌL during the screening period;
β. Female trial participants of childbearing potential and their male partners, and male trial participants and their female partners, must agree to use an effective method of contraception during the study and for 6 months after the last dose of investigational drug, and have no plans for childbirth, sperm donation, or ovum donation (see Appendix 1: Contraceptive Measures, Definition of Childbearing Potential, and Contraception Requirements for details).
Exclusion criteria
β. Presence of any respiratory disorder other than COPD, including:
β. AECOPD (including mild, moderate, and severe; for definitions of moderate and severe AECOPD, see Inclusion Criterion 4, item 3) and/or respiratory tract infection within 4 weeks prior to screening and before randomization;
β. Signs and/or symptoms of cor pulmonale and/or right ventricular failure;
β. Currently receiving or planning to start long-term oxygen therapy (\>15 hours of oxygen per day) or mechanical ventilation during the study;
β. Participation or planned participation in an intensive COPD rehabilitation program within 4 weeks prior to screening (trial participants in the maintenance phase of a rehabilitation program may be considered for enrollment);
β. Planned pulmonary resection or lung volume reduction surgery, or a history of such surgery;
β. Presence of any Grade β₯2 (NCI-CTCAE version 6.0) lipid profile abnormalities (the influence of physiological factors such as diet should be excluded);