A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis.

NCT06277245 | Completed Phase 3

• 1 other identifier: LK001303
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable). The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Eczema Area and Severity Index (EASI-75) at Week 16

  EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease .

  Baseline and Week 16

• Investigator's Global Assessment (IGA) score of 0/1 at Week 16

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

  Baseline and Week 16

Secondary Outcomes (4)

• Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16

  Baseline and Week 16

• Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at all visits other than Week 16.

  Baseline to week 52 other than Week 16.

• Change from Baseline in Eczema Area and Severity Index at all visits.

  Baseline to week 52

• Eczema Area and Severity Index (EASI 75) at all visits other than Week 16

  Baseline to week 52 other than Week 16

Study Arms (4)

LNK01001 12 mg

EXPERIMENTAL

o Period 1: Participants receive LNK01001 12 mg twice daily for 16 weeks. Period 2: Participants will continue on LNK01001 12 mg twice daily from Week 16 to Week 52.

Drug: LNK01001

LNK01001 24 mg

EXPERIMENTAL

o Period 1: Participants receive LNK01001 24 mg twice daily for 16 weeks. Period 2: Participants will continue on LNK01001 24 mg twice daily from Week 16 to Week 52.

Drug: LNK01001

Placebo / LNK01001 12 mg

PLACEBO COMPARATOR

o Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 12 mg twice daily from Week 16 to Week 52.

Drug: LNK01001; Drug: Placebo

Placebo / LNK01001 24mg

PLACEBO COMPARATOR

o Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 24 mg twice daily from Week 16 to Week 52.

Drug: LNK01001; Drug: Placebo

Interventions

LNK01001 DRUG

Capsule; Oral

LNK01001 12 mg; LNK01001 24 mg; Placebo / LNK01001 12 mg; Placebo / LNK01001 24mg

Placebo DRUG

Capsule; Oral

Placebo / LNK01001 12 mg; Placebo / LNK01001 24mg

Eligibility Criteria

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

You may qualify if:

• Participants must be at least ≥18 and ≤75 years of age.
• The subject has a diagnosis of atopic dermatitis for at least 1 year.
• Meets the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4.
• Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit.

You may not qualify if:

• Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product unable or unwilling to discontinue current atopic dermatitis treatments before the study.
• Requirement of prohibited medications during the study.
• Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
• History of malignancy or current diagnosis of malignancy before screening visit.
• In the opinion of the investigator or sponsor, any uncontrolled clinically significant laboratory abnormality that would affect the interpretation of study data or the subject's participation in the study uncontrolled diabetes, hypertension, kidney disease, liver disease, or severe heart disease.

Sponsors & Collaborators

• Lynk Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Dermatological Hospital of Southern Medical University

Guangzhou, 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

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

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: February 2, 2024
• First Posted: February 26, 2024
• Study Start: February 6, 2024
• Primary Completion: April 18, 2025
• Study Completion: January 12, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)