Evaluation of the Efficacy and Safety of Oral LW402 Tablets for the Treatment of Patients With Moderate-to-Severe Atopic Dermatitis

Shanghai Longwood Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Moderate to Severe Atopic Dermatitis

Treatments: Drug: LW402; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07370909

LW402-III-02

Details and patient eligibility

About

This Phase 3, double-blind (sponsor-open), multicenter, placebo-controlled study aims to evaluate the efficacy and safety of oral LW402 tablets in patients with moderate to severe atopic dermatitis.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects voluntarily provided informed consent and agreed to participate in the study.

• Gender: no restrictions; Age: 18 to 75 years inclusive (as of the date of signing the informed consent form).

• At screening, subjects met the Hanifin-Rajka diagnostic criteria for atopic dermatitis (AD) (Appendix 4) and had a documented AD history of ≥1 year prior to screening.

• At screening and baseline visits, subjects were required to have moderate-to-severe atopic dermatitis (AD) with all three of the following criteria satisfied:

  • Total AD lesion area ≥ 10% of body surface area (BSA)
  • Investigator's Global Assessment (IGA) score ≥ 3
  • Eczema Area and Severity Index (EASI) score ≥ 16

Exclusion criteria

• Subjects with a documented history of hypersensitivity to Janus kinase (JAK) inhibitors.
• Subjects with current or a history of autoimmune diseases other than atopic dermatitis (AD) (e.g., systemic lupus erythematosus [SLE], inflammatory bowel disease [IBD], Felty's syndrome, scleroderma, inflammatory myopathy, other connective tissue diseases, overlap syndrome) or other skin conditions that may interfere with AD assessment (e.g., contact dermatitis, psoriasis).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 3 patient groups, including a placebo group

LW402 100 mg, PO BID

Experimental group

Treatment:

Drug: LW402

LW402 150 mg, PO BID

Experimental group

Treatment:

Drug: LW402

LW402 placebo tablets,PO.BID

Placebo Comparator group

Treatment:

Drug: Placebo