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A Phase Ib/IIa Study Assessing the Rapid Onset Characteristics of TLL-018 for Moderate-to-Severe CSU With Inadequate Response to Second-Generation H1 Antihistamines

NCT07665996 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-07-01

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines.

The main objectives are:

To evaluate the rapid onset characteristics of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.

To evaluate the safety profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.

To evaluate the pharmacokinetic (PK) profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.

Participants will be randomly allocated at a 1:1:1 ratio to receive TLL-018 10 mg, TLL-018 20 mg, or placebo orally after meals.

Conditions

  • Chronic Spontaneous Urticaria (CSU)

Interventions

DRUG

TLL-018

Participants will receive TLL-018 10 mg (1 tablet) and placebo (1 tablet) orally after meals, with a dosing interval of 12 hours (±15 minutes)

DRUG

TLL-018

Participants will receive TLL-018 20 mg (2 tablets) orally after meals, with a dosing interval of 12 hours (±15 minutes)

DRUG

Placebo

Participants will receive placebo (2 tablets) orally after meals, with a dosing interval of 12 hours (±15 minutes)

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
2026-07-15
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT07665996 on ClinicalTrials.gov