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NOT YET RECRUITING
NCT07784816
PHASE2/PHASE3

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

Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Official title: A Phase II/III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profiles of TLL-018 in Patients With Moderate-to-Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2026-08-31

Completion Date

2029-09-30

Last Updated

2026-08-25

Healthy Volunteers

No

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

Locations (1)

Peking University People's Hospital

Beijing, China