Moderate to severe atopic dermatitis
Conditions
Interventions
XKH-001 treating group:The first subcutaneous injection (600mg) was administered, followed by a dose every 4 weeks for a total of 5 doses.
Sponsors
Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Both males and females are eligible, aged 18 to 65 years (inclusive) on the day of signing the informed consent. 2. Diagnosed with atopic dermatitis (AD) according to the 2014 consensus criteria of the American Academy of Dermatology (AAD), with a disease duration of at least 6 months prior to signing the informed consent. 3. At the screening visit and baseline visit, the severity of AD is moderate to severe, defined as meeting all of the following 4 criteria simultaneously: Eczema Area and Severity Index (EASI) score >= 16, Investigator’s Global Assessment (IGA) score >= 3, Body Surface Area (BSA) percentage affected by lesions >= 10%, and weekly average of daily peak pruritus Numerical Rating Scale (NRS) score >= 4.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with biologics for AD (e.g., dupilumab, tralokinumab), XKH001, or medicine targeting the same target (including investigational medicinal products). 2. Received allergen-specific immunotherapy for AD within 6 months prior to the first dose; received the following systemic medications for AD within 4 weeks prior to the first dose: systemic corticosteroids (SCS), immunosuppressants/immunomodulators (e.g., cyclosporine, mycophenolate mofetil, interferon-? (IFN-?), Janus kinase (JAK) inhibitors, azathioprine, methotrexate), and traditional Chinese medicines for AD (including modern Chinese medicinal preparations). 3. Received ultraviolet therapy for AD within 4 weeks prior to the first dose (including but not limited to narrow-band ultraviolet B (NB-UVB) and medium-to-high dose UVA1); initiated treatment with prescription emollients or emollients containing active ingredients (e.g., ceramides, hyaluronic acid, urea, or filaggrin breakdown products) during the screening period (such emollients may be continued at a stable dose if already initiated prior to signing informed consent). 4. Received **=3 bleach baths** per week for AD within any one week during the 4 weeks prior to the first dose. 5. Received the following topical medications for AD within 2 weeks prior to the first dose: TCS or TCI; other topical agents including but not limited to topical phosphodiesterase 4 (PDE-4) inhibitors (e.g., crisaborole), JAK inhibitors (e.g., ruxolitinib), and traditional Chinese medicines (including modern Chinese medicinal preparations); Received other biologic agents within 5 elimination half-lives (if known) or 16 weeks prior to the first dose, whichever is longer; Received treatment with an investigational medicinal product (XKH001 or drugs targeting the same target, see Exclusion Criterion 1) or a medical device within 8 weeks or 5 elimination half-lives prior to the first dose, whichever is longer (if applicable). 6. History of known or suspected immunosuppressive disorders, including a history of invasive opportunistic infections (e.g., tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved/regressed; or, in the investigator’s judgment, abnormally frequent, recurrent, or prolonged infections (Note: confirmed/suspected active or untreated latent TB must be excluded). 7. Had a chronic active or acute infection within 2 weeks prior to the first dose requiring systemic therapy with antibiotics, antiviral agents, antiparasitic agents, antiprotozoal agents, or antifungal agents; or had a superficial skin infection within 1 week prior to the first dose (Note: Re-screening may be performed once after the infection has resolved). 8. Comorbid uncontrolled chronic disease requiring high-dose SCS, such as uncontrolled severe asthma (defined as an ACQ-5 score >= 1.5 or a history of >= 2 asthma exacerbations requiring systemic corticosteroids or hospitalization for > 24 hours within 12 months prior to signing informed consent). 9. Laboratory abnormalities listed below present within 7 days prior to the first dose: Hemoglobin (Hb) 3 × upper limit of normal (ULN); Total bilirubin (TBIL) > 1.5 × ULN (> 3 × ULN for subjects with Gilbert's syndrome); Creatinine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI);Single-cell RNA sequencing of immune cells in peripheral blood and skin lesion tissues;Fine phenotypic characterization of mononuclear cells in peripheral blood; | — |
Countries
China
Contacts
Public ContactLiming Wu
Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Outcome results
None listed