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 range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. The trial participant must be aged 40-80 years (inclusive) at the time of signing the ICF, can be either male or female;
. The trial participant has a BMI ≥16.0 kg/m2;
. Trial participants diagnosed with COPD for ≥12 months (diagnosed according to GOLD 2024) and meeting the following criteria:
. Whole blood EOS count ≥150/μL during the screening period;
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Presence of any respiratory disorder other than COPD, including:
. 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;
. Signs and/or symptoms of cor pulmonale and/or right ventricular failure;
. Hypercapnia requiring the use of BiPAP;
. Currently receiving or planning to start long-term oxygen therapy (\>15 hours of oxygen per day) or mechanical ventilation during the study;
. 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);
. Planned pulmonary resection or lung volume reduction surgery, or a history of such surgery;
. Presence of any Grade ≥2 (NCI-CTCAE version 6.0) lipid profile abnormalities (the influence of physiological factors such as diet should be excluded);