NCT07054736

Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable.

Detailed description

This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable. With the disease severity assessed at the baseline visit-IGA: 3 points (moderate) vs. 4 points (severe) used as the stratification factors, a central randomization system will be used to randomly assign the patients to 3 dose groups of the study drug XKH001 (100 mg quaque 4 weeks , 300 mg quaque 4 weeks , 600 mg quaque 4 weeks ) and the placebo group in a 1:1:1:1 ratio, with 30 patients in each group. This study aims to evaluate the safety, efficacy, PK and PD characteristics, and immunogenicity of XKH001 in adult patients with moderate-to-severe Atopic Dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	XKH001 Injection	100 mg quaque 4 weeks dose group: Subjects will receive 1 mL (1 vial) of XKH001 injection (100 mg) and 5 mL (5 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times. 300 mg quaque 4 weeks dose group: Subjects will receive 3 mL (3 vials) of XKH001 injection (300 mg) and 3 mL (3 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times. 600 mg quaque 4 weeks dose group: Subjects will receive 6 mL (6 vials) of XKH001 injection (600 mg) subcutaneously each time, once every 4 weeks, for a total of 5 times.
DRUG	XKH001 Placebo Injection	Subjects will receive 6 mL (6 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times.

Timeline

• Start date: 2025-08-31
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study