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.
The trial participant understands and voluntarily signs the informed consent form (ICF), and has the willingness and ability to complete the scheduled follow-up visits, treatment plans, laboratory tests, and other trial procedures required by the protocol.
Male or female trial participants aged ≥18 and ≤75 years at the time of signing the ICF.
Have a history of atopic dermatitis for at least 1 year at screening, and meet the Hanifin-Rajka diagnostic criteria.
At screening and randomization, meet the criteria for moderate-to-severe atopic dermatitis as assessed by the investigator, with all of the following 4 conditions met simultaneously: Eczema Area and Severity Index (EASI) ≥16; Investigator's Global Assessment (IGA) ≥3; Body Surface Area (BSA) affected by atopic dermatitis ≥10%; Weekly average of Worst Itch Numeric Rating Scale (WI-NRS) ≥4.
Inability to swallow investigational product, refractory nausea/vomiting, malabsorption, external biliary diversion; history of gastrointestinal perforation (excluding perforation secondary to appendicitis or mechanical trauma); gastrointestinal disorders impairing drug absorption or other malabsorption conditions.
Concurrent active inflammatory skin diseases that may confound efficacy assessment.
Current or prior lymphoproliferative disorders, or suggestive signs/symptoms including lymphadenopathy or splenomegaly.
History of malignancy prior to screening, except for treated-and-cured non-melanoma skin cancer/basal-cell carcinoma, cervical carcinoma in-situ, or breast ductal carcinoma in-situ.
Parallel
TLL-018 tablets
DrugTLL-018 tablets taken orally 10 mg (1 tablet) twice daily
TLL-018 tablets
DrugTLL-018 tablets taken orally 20 mg (2 tablets) twice daily
TLL-018 tablets
DrugTLL-018 tablets taken orally 30 mg (3 tablets) twice daily
Placebo
DrugPlacebo taken orally twice daily
Proportion of trial participants achieving at least 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) at Week 16
The Eczema Area and Severity Index (EASI) is a validated, physician-assessed tool used to measure the extent and severity of atopic dermatitis (eczema). The total score ranges from 0 to 72, with higher scores indicating more severe disease.
Proportion of trial participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with a reduction of ≥ 2 points at Week 16
The Investigator's Global Assessment (IGA) is a physician-reported, static measure used to rate the overall severity of atopic dermatitis at a given time point. It typically uses a 5-point scale from 0 to 4: 0 = Clear, 4 = Severe.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
