Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients

Sponsor
Longbio Pharma
Study ID
NCT07342803
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • LP-003 Injection — BIOLOGICAL
    s.c. injection, Q12W
  • Omalizumab — BIOLOGICAL
    s.c. injection, Q4W
  • Placebo — BIOLOGICAL
    s.c. injection, Q4W

Study Details

This is a multicenter, randomized, masked, active and placebo controlled, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-003 injection in adult patients with moderate to severe persistent allergic asthma.

Key Dates

Start date
Jan 25, 2025
Status verified
Oct 2025
Primary completion
Dec 28, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LP-003 150 mg group
    Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks.
  • Experimental: LP-003 300 mg group
    Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks.
  • Experimental: LP-003 450 mg group
    Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks.
  • Active Comparator: Omalizumab group
    Participants received subcutaneous injection of Omalizumab every 4 weeks; the dose was determined by baseline IgE level and body weight, with a maximum dose 600 mg.
  • Placebo Comparator: Placebo group
    Participants received subcutaneous injection of Placebo every 4 weeks.

Primary Outcome Measure

Mean number of asthma exacerbations per subject [ Time Frame: During the 24-week treatment period ]

Central Contacts

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