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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profiles of TLL-018 in Patients With Moderate-to-Severe Atopic Dermatitis

NCT07784816 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-08-25

No results posted yet for this study

Summary

This is an operationally seamless Phase II/III, multicenter, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe atopic dermatitis (AD). The Phase II stage aims to preliminarily evaluate the efficacy of TLL-018 and identify the dose and sample size for the subsequent Phase III stage, which is designed to confirm the efficacy of TLL-018.

The primary outcome measures are the proportion of participants achieving EASI-75 (≥75% improvement in Eczema Area and Severity Index from baseline) at week 16, and the proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with a ≥2-point reduction from baseline at week 16.

Conditions

  • Atopic Dermatitis (AD)

Interventions

DRUG

TLL-018 tablets

TLL-018 tablets taken orally 10 mg (1 tablet) twice daily

DRUG

TLL-018 tablets

TLL-018 tablets taken orally 20 mg (2 tablets) twice daily

DRUG

TLL-018 tablets

TLL-018 tablets taken orally 30 mg (3 tablets) twice daily

DRUG

Placebo

Placebo taken orally twice daily

Sponsors & Collaborators

  • Hangzhou Highlightll Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784816 on ClinicalTrials.gov