A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis

Lynk Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: LNK01001 Dose A; Drug: LNK01001 Dose B; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06085521

LK001202

Details and patient eligibility

About

Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 dose A or LNK01001 dose B or matching placebo for 12 weeks.

Full description

The study was to include a 12-week double-blind treatment period. Participants who met eligibility criteria were to be randomized in a 1:1:1 ratio to one of the three treatment groups.

Group 1:LNK01001 dose A (Day 1 to Week 12) Group 2:LNK01001 dose B (Day 1 to Week 12) Group 3: Matching placebo (Day 1 to Week 12)

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participants between ≥ 18 and ≤75 years of age.
• subjects meet Hanifin and Rajka criteria.
• subjects meet moderate to severe AD criteria.
• inadequate response to topical treatment or systemic treatment for AD within 6 months before screening.

Exclusion criteria

• current use of topical treatment for AD within 2 weeks before baseline visit.
• prior exposure to Janus Kinase (JAK) inhibitor.
• prior exposure to phototherapy, tanning bed, or any other light emitting device treatment within 4 weeks before baseline visit.
• Prior exposure to any Biologic treatment including Dupilumab, Omalizumab within 3 months before baseline visit.
• Any significant clinical and laboratory abnormalities, as determined by the Investigator, may affect the safety of the subjects, including but not limited to:WBC<3×10e9/L, neutrophil<1.2×10e9/L, platelet<100×10e9/L, hemoglobin<85 g/L; Aspartate aminotransferase or alanine aminotransferase>1.5×ULN, or total bilirubin>1.5×ULN; Serum creatinine>1.2×ULN.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

LNK01001 Dose A

Experimental group

Description:

Participants will receive LNK01001capsule Dose A BID orally for 12 weeks.

Treatment:

Drug: LNK01001 Dose A

LNK01001 Dose B

Experimental group

Description:

Participants will receive LNK01001capsule Dose B BID orally for 12 weeks.

Treatment:

Drug: LNK01001 Dose B

placebo

Placebo Comparator group

Description:

Participants will receive a Placebo capsule BID orally for 12 weeks.

Treatment:

Drug: placebo