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

NCT07054736 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: XKH001-01-II
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Primary Objective1

  Proportion of subjects with an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) and a reduction of ≥2 points from baseline to Week 16.

  Week16

• Primary Objective2

  Proportion of subjects with Treatment Emergent Serious Adverse Events (TESAEs) from baseline to Week 16

  Week16

Secondary Outcomes (6)

• Secondary Objective1

  Week16

• Secondary Objective2

  Week16

• Secondary Objective3

  Week4

• Secondary Objective4

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

• Secondary Objective5

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

Other Outcomes (1)

• Exploratory Objective

  Week16

Study Arms (4)

100mg

ACTIVE COMPARATOR

100mg,quaque 4 weeks

Drug: XKH001 Injection; Drug: XKH001 Placebo Injection

300mg

ACTIVE COMPARATOR

300mg,quaque 4 weeks

Drug: XKH001 Injection; Drug: XKH001 Placebo Injection

600mg

ACTIVE COMPARATOR

600mg,quaque 4 weeks

Drug: XKH001 Injection; Drug: XKH001 Placebo Injection

Placebo

PLACEBO COMPARATOR

Placebo,quaque 4 weeks

Drug: XKH001 Placebo Injection

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.

100mg; 300mg; 600mg

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.

100mg; 300mg; 600mg; Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all the following criteria to be eligible for participation in this study:
• Both males and females, aged 18 to 65 years (inclusive) on the day of signing the informed consent;
• Diagnosed with Atopic dermatitis according to the American Academy of Dermatology consensus criteria (2014) and with a history of disease for at least 6 months prior to signing the informed consent;
• At the screening and baseline visits, the severity of Atopic dermatitis is classified as moderate to severe, that is, the following 4 conditions are met simultaneously; Eczema Area and Severity Index (EASI) score ≥ 16 points; Investigator's Global Assessment (IGA) score ≥ 3 points; Percent Body Surface Area (BSA) ≥10%; Weekly mean of daily Peak Pruritus Numerical Rating Scale (NRS) score ≥ 4 points;
• If the investigator determines that topical drug therapy used within 6 months prior to signing the informed consent was insufficiently effective or unsuitable, at least one of the following conditions must be met:
• Received ≥ 4 weeks of medium/potent topical corticosteroids (TCSs) or ≥ 2 weeks of super potent TCSs (combined with the longest treatment course recommended in the drug instructions, whichever is shorter) ± topical calcineurin inhibitors (TCIs), but did not achieve and maintain remission or a lower disease activity state (equivalent to IGA = 0 to 2); Received systemic corticosteroids (SCSs) and other systemic treatments for AD is also considered an insufficient response to topical drug therapy; Not suitable for topical drug therapy (e.g., intolerance or contraindications);
• Application of a stable dose of basic, mild, inactive ingredient-free topical emollients (moisturizers) twice daily for at least 7 consecutive days before the first dose and throughout the study.
• Subjects of childbearing potential and their partners must voluntarily use effective contraceptive methods during the study and continue for 6 months after the final dose; Note: Women of childbearing potential are those who have not undergone sterilization and either have not yet experienced menopause, have experienced menopause for less than 1 year, or have been menopausal for 1 year or more but have pathological conditions affecting menopause. Such women are considered to have potential fertility.
• Subjects must voluntarily sign the informed consent before any study-related procedures begin, be able to communicate effectively with the investigator, and understand and agree to adhere strictly to the protocol requirements.

You may not qualify if:

• Subjects who meet any of the following criteria should not be enrolled in this study:
• Previous treatment with biological agents for Atopic dermatitis (e.g., dupilumab, tralokinumab), XKH001, or drugs with the same target (including investigational products);
• Allergen-specific immunization therapy for Atopic dermatitis within 6 months prior to the first dose;
• Systemic drug therapy for Atopic dermatitis within 4 weeks prior to the first dose:
• Systemic corticosteroids (SCS); Immunosuppressants/immunomodulators (e.g., cyclosporin, mycophenolate mofetil, interferon-γ (IFN-γ), Janus kinase (JAK) inhibitors, azathioprine, methotrexate); Traditional Chinese medicine (including modern Chinese medicine preparations) for Atopic dermatitis treatment;
• Ultraviolet for Atopic dermatitis (including but not limited to narrow-band ultraviolet B (NB-UVB) and medium-to-high dose UVA1) within 4 weeks prior to the first dose;
• Treatment with prescription emollients or emollients containing active ingedients (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products) initiated during the screening period (if such emollients are used prior to signing the informed consent, they can be continued at a stable dose);
• ≥3 times of bleach bath therapy for Atopic dermatitis in any week within 4 weeks prior to the first dose;
• The following topical drug therapy for Atopic dermatitis within 2 weeks prior to the first dose:
• TCS or TCI; Other topical drugs: including but not limited to topical phosphodiesterase 4 (PDE-4) inhibitors (e.g., Crisaborole), JAK inhibitors (e.g., Ruxolitinib), traditional Chinese medicine (including modern Chinese medicine preparations);
• Treatment with other biological agents within 5 half-lives (if known) or 16 weeks (whichever is longer) prior to the first dose;
• Known or suspected history of immunosuppressive diseases, including history of invasive opportunistic infections (such as tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved/subsided; or abnormally frequent, recurrent, or prolonged infections as determined by the investigator (Note: Confirmed/suspected active or therapy naive latent TB must be excluded);
• Chronic active or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to the first dose; or superficial skin infection within 1 week prior to the first dose (Note: Subjects can be re-screened after the infection has resolved);
• Uncontrolled chronic diseases requiring extensive use of SCS, such as uncontrolled severe asthma (defined as ACQ-5 score ≥1.5 or history of ≥ 2 SCS use or hospitalization \> 24 hours for asthmatic attack in the 12 months prior to signing the informed consent);
• Laboratory test abnormal within 7 days prior to the first dose:

Sponsors & Collaborators

• Zhejiang Kanova Biopharmaceutical Co., LTD: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jianzhong Zhang, Dr

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianzhong Zhang, Dr

CONTACT

010-88325471; rmzjz@126.com

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: July 8, 2025
• Study Start: August 31, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)