Trials / Completed
CompletedNCT06228560
Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment
Multi-center,Randomized,Double-blind Phase II Study to Evaluate the Efficacy and Safety of LP-003 in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 202 (actual)
- Sponsor
- Longbio Pharma · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is a Phase II, multicenter, randomized, double-blind study to evaluatethe efficacy and safety of LP-003 administered subcutaneously as an add-on therapy for the treatment of adult patients aged 18-75 who have been diagnosed with refractory CSU and who remain symptomatic despitestandard-dose H1 antihistamine treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | LP-003 | Liquid in vial |
| BIOLOGICAL | Placebo | Liquid in vial |
| BIOLOGICAL | Omalizumab | Liquid in vial |
Timeline
- Start date
- 2024-01-26
- Primary completion
- 2025-04-17
- Completion
- 2025-11-14
- First posted
- 2024-01-29
- Last updated
- 2025-12-12
Locations
20 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06228560. Inclusion in this directory is not an endorsement.