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

NCT07370909 | Not Yet Recruiting Phase 3

• 1 other identifier: LW402-III-02
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moderate to Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects achieving ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline at Week 16 (EASI 75)

  Week 16

• Proportion of subjects achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with a ≥2-point reduction from baseline at Week 16

  Week 16

Study Arms (3)

LW402 100 mg, PO BID

EXPERIMENTAL

Drug: LW402

LW402 150 mg, PO BID

EXPERIMENTAL

Drug: LW402

LW402 placebo tablets,PO.BID

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LW402 DRUG

LW402 tablets

LW402 100 mg, PO BID; LW402 150 mg, PO BID

Placebo DRUG

LW402 placebo tablets

LW402 placebo tablets,PO.BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tigermed Consulting Co., Ltd: collaborator
• Shanghai Longwood Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

Study Officials

• Janzhong Zhang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Chen

CONTACT

+86-21-63634910; barbara@lwbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (1)