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

NCT06396026 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hangzhou Highlightll Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-12-24
Primary Completion
2026-03-30
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06396026 on ClinicalTrials.gov