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

Sponsor
Zhejiang Kanova Biopharmaceutical Co., LTD
Study ID
NCT07054736
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • XKH001 Injection — DRUG
    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.
  • XKH001 Placebo Injection — DRUG
    Subjects will receive 6 mL (6 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times.

Study Details

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.

Key Dates

First listed
Jul 8, 2025
Start date
Aug 31, 2025
Status verified
Jun 2025
Primary completion
Oct 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 100mg
    100mg,quaque 4 weeks
  • Active Comparator: 300mg
    300mg,quaque 4 weeks
  • Active Comparator: 600mg
    600mg,quaque 4 weeks
  • Placebo Comparator: Placebo
    Placebo,quaque 4 weeks

Primary Outcome Measure

Primary Objective1 [ Time Frame: Week16 ]

Central Contacts

Find similar trials

Nationwide
Atopic dermatitis / eczema trialsDermatology trialsRheumatology trialsAutoimmune disease trials

Related Studies