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

NCT06085521 | Completed Phase 2

• 1 other identifier: LK001202
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score

  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.

  week 12

Secondary Outcomes (11)

• Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75)

  Week 4,8,12

• Percentage of Participants Achieving an Investigator Global Assessment (IGA) response

  Week 4,8,12

• Percent Change from Baseline in EASI Score

  Week 4,8

• Percentage of Participants Achieving a Reduction of ≥ 3 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS)

  Week 4,8,12

• Change From Baseline in Worst Pruritus Numerical Rating Scale(NRS) Score

  Week 4,8,12

Study Arms (3)

LNK01001 Dose A

EXPERIMENTAL

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

Drug: LNK01001 Dose A

LNK01001 Dose B

EXPERIMENTAL

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

Drug: LNK01001 Dose B

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

LNK01001 Dose A DRUG

Capsules taken orally

LNK01001 Dose A

LNK01001 Dose B DRUG

Capsules taken orally

LNK01001 Dose B

placebo DRUG

Capsules taken orally

placebo

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lynk Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Jianzhong Zhang

Beijing, 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: January 26, 2022
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

CN (1)