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

L

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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