At a glance
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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
In Brief
A Phase 2 clinical trial evaluating XKH001 Injection and XKH001 Placebo Injection for Atopic Dermatitis. Not yet recruiting, targeting 120 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
Subjects will receive 6 mL (6 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times.