FindTrial
Sign In

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients with Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524006-14-00
Enrollment
30
Registered
2026-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Spontaneous Urticaria

Brief summary

Change from baseline in UAS7 at Week12

Detailed description

1. Proportion of participants achieving complete control (UAS7=0) at Week 12, 2. Proportion of participants achieving well-controlled urticaria (UAS7≤6) at Week 12, 3. Cumulative number of weeks with an AAS7=0 response between baseline and Week 12, 4. Change from baseline in DLQI score at Week 12, 5. Safety endpoints will be included but not be limited to: - Occurrence of treatment emergent adverse events during the study; - Occurrence of treatment emergent serious adverse events during the study

Interventions

DRUGSubcutaneous injection of with no active ingredient contained

Sponsors

Yuhan Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in UAS7 at Week12—

Secondary

MeasureTime frame
1. Proportion of participants achieving complete control (UAS7=0) at Week 12, 2. Proportion of participants achieving well-controlled urticaria (UAS7≤6) at Week 12, 3. Cumulative number of weeks with an AAS7=0 response between baseline and Week 12, 4. Change from baseline in DLQI score at Week 12, 5. Safety endpoints will be included but not be limited to: - Occurrence of treatment emergent adverse events during the study; - Occurrence of treatment emergent serious adverse events during the study—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 28, 2026