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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-26

Study Completion Date

2023-06-14

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LNK01001 Dose A

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

Group Type EXPERIMENTAL

LNK01001 Dose A

Intervention Type DRUG

Capsules taken orally

LNK01001 Dose B

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

Group Type EXPERIMENTAL

LNK01001 Dose B

Intervention Type DRUG

Capsules taken orally

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Capsules taken orally

Interventions

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LNK01001 Dose A

Capsules taken orally

Intervention Type DRUG

LNK01001 Dose B

Capsules taken orally

Intervention Type DRUG

placebo

Capsules taken orally

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No