Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Sponsor
Longbio Pharma
Study ID
NCT06228560
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LP-003 — BIOLOGICAL
    Liquid in vial
  • Placebo — BIOLOGICAL
    Liquid in vial
  • Omalizumab — BIOLOGICAL
    Liquid in vial

Study Details

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.

Key Dates

First listed
Jan 29, 2024
Start date
Jan 26, 2024
Status verified
Dec 2025
Primary completion
Apr 17, 2025
Completion
Nov 14, 2025

Study Design

Enrollment
202 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LP-003 group 1
    Participants received LP-003 subcutaneously during the 24-week treatment period
  • Experimental: LP-003 group 2
    Participants received LP-003 subcutaneously during the 24-week treatment period
  • Experimental: LP-003 group 3
    Participants received LP-003 subcutaneously during the 24-week treatment period
  • Active Comparator: Omalizumab
    Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24-week treatment period
  • Placebo Comparator: Placebo
    Participants received placebo subcutaneously every 4 weeks during the 24-week treatment period

Primary Outcome Measure

The proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 12 [ Time Frame: Week 12 ]

Related Studies