Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection

NCT07519499 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: XKH001-04-II
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• Primary Outcome1

  Causal relationship to the investigational product of TEAEs

  Week 36

• Primary Outcome2

  Change from baseline in post-bronchodilator FEV1 (mL) at Week 28

  Week 28

Secondary Outcomes (14)

• Secondary Outcome1

  Weeks 2, 4, 8, 12, 16, 20, 24, and 32;

• Secondary Outcome2

  Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32

• Secondary Outcome3

  Week 28

• Secondary Outcome4

  Week 28

• Secondary Outcome5

  Weeks 4, 8, 12, 16, 20, 24, 28, and 32

Study Arms (3)

XKH001 300mg

ACTIVE COMPARATOR

XKH001 Injection 300 mg once every four weeks \[Q4W\]

Drug: XKH001Injection; Drug: Placebo

XKH001 600mg

ACTIVE COMPARATOR

XKH001 Injection 600 mg once every four weeks \[Q4W\]

Drug: XKH001Injection

Placebo group

PLACEBO COMPARATOR

Placebo once every four weeks \[Q4W\]

Drug: Placebo

Interventions

XKH001Injection DRUG

XKH001, developed by Zhejiang Kanova Biopharmaceutical Co., Ltd., is a recombinant anti-IL-25 humanized IgG1 monoclonal antibody (mAb) composed of two identical light chains and two identical heavy chains linked by disulfide bonds. Each light chain consists of 215 amino acids, and each heavy chain consists of 455 amino acids, for a total of 1340 amino acids. XKH001 has a total of 16 pairs of disulfide bonds, including 4 pairs of intra-light chain disulfide bonds, 8 pairs of intra-heavy chain disulfide bonds, 2 pairs of light-heavy interchain disulfide bonds, and 2 pairs of heavy-heavy interchain disulfide bonds. XKH001 has an N-glycosylation site at N305 of the heavy chain, with G0F oligosaccharide being the major form of N-glycosylation.

Also known as: XKH001

XKH001 300mg; XKH001 600mg

Placebo DRUG

Placebo

Placebo group; XKH001 300mg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Current smoker or ex-smoker with a smoking history of ≥10 pack-years (1 pack-year is calculated as: \[average number of cigarettes smoked per day × number of years\]/20; e.g., 1 pack-year = smoking 20 cigarettes per day for 1 year, or smoking 10 cigarettes per day for 2 years.); Moderate to severe airflow limitation (post-bronchodilator FEV1/FVC \<70%, post-bronchodilator FEV1 measurement ≥30% and \<80% of predicted value);
• Documented high risk of exacerbations, defined as ≥2 moderate or ≥1 severe exacerbations in the year prior to screening: A moderate exacerbation is defined as an AECOPD requiring the use of systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics (however, the use of antibiotics alone does not qualify as a moderate exacerbation unless it is documented that the antibiotic use was necessary to treat worsening COPD symptoms); one of the two required moderate exacerbations must have required systemic corticosteroids; a severe exacerbation is defined as an AECOPD requiring hospitalization or observation in an emergency room/urgent care facility for \>24 hours;
• Received inhaled background maintenance therapy \[triple therapy (ICS + LABA + LAMA) or dual therapy (LABA + LAMA or ICS + LABA)\] for ≥3 months before randomization, with a stable dose for at least 1 month before signing the ICF and during the screening period;
• 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).

You may not qualify if:

• Trial participants with any of the following cannot be enrolled in this study:
• Presence of any respiratory disorder other than COPD, including:
• Current diagnosis of asthma or a history of asthma according to the GINA or other recognized guidelines;
• Diagnosis of alpha-1 antitrypsin deficiency;
• Other concomitant active or clinically significant respiratory disorders that would significantly affect the study: such as active pulmonary tuberculosis, lung cancer (including suspected malignant pulmonary nodule \[Category 4\]), bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung disease, cystic fibrosis, obliterative bronchiolitis, pulmonary arterial hypertension, etc.;
• 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);
• Concomitant autoimmune disease requiring systemic immunosuppressant therapy (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis);
• Known or suspected history of an immunosuppressive disease, including a history of invasive opportunistic infections (e.g., TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved/subsided; or, in the investigator's judgment, a history of abnormally frequent, recurrent, or prolonged infections;
• Confirmed active infection parasitic; suspected infection parasitic or high risk of infection, unless clinical assessment and (if necessary) laboratory assessment have ruled out active infection before randomization;
• Confirmed acute or chronic infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitic, or antiprotozoals within 4 weeks prior to screening or during the screening period;

Sponsors & Collaborators

• Zhejiang Kanova Biopharmaceutical Co., LTD: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ting Yang

  China-Japan Friendship Hospital

  STUDY CHAIR

Central Study Contacts

Ting Yang

CONTACT

13651380809; dryangting@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible trial participants from screening (a total of 75 participants, including 45 with a whole blood EOS count ≥300/μL and 30 with an EOS count \<300/μL) will enter the 28-week Treatment Period (dosing with investigational drug or placebo once every 4 weeks for a total of 7 doses), and their eligibility for enrollment will be reconfirmed before randomization. On Day 1, participants will be randomized in a 1:1:1 ratio to two dose groups of the investigational drug XKH001 Injection (300 mg once every four weeks \[Q4W\] or 600 mg Q4W) or placebo group, with 25 participants in each group, stratified by whole-blood EOS count (≥300/μL vs. \<300/μL) during the screening. During the treatment period, trial participants will undergo corresponding efficacy and safety assessments at specified time points (including before each dose administration). Sampling for laboratory tests must be completed before administration.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share