NCT06396026

A Study of Efficacy and Safety of TLL-018 in CSU Participants

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria With Inadequate Controll to Second Generation H1-antihistamines

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (estimated)
• Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) With Inadequate Controll to Second Generation H1-antihistamines.

Detailed description

This is a randomized, double-blind, single-dummy, placebo-parallel-group, phase 3 study to assess the safety and efficacy of TLL-018 in Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) participants who had an Inadequate Controll to Second Generation H1-antihistamines.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	TLL-018 tablets	Oral TLL-018 tablets taken orally 1 pieces BlD for 52 weeks
DRUG	Placebo tablets	Oral Placebo tablets taken orally 1 pieces BlD for 12 weeks and then Oral TLL-018 tablets taken orally 1 pieces BlD for 40 weeks.

Timeline

• Start date: 2024-12-24
• Primary completion: 2026-03-30
• Completion: 2027-12-30
• First posted: 2024-05-02
• Last updated: 2024-12-27

Locations

1 site across 1 country: China