Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study ID
NCT04944602
Phase
PHASE3
Status
Unknown

Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

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

Interventions

Study Details

• This study is a multicenter, randomized, double-blind, parallel-group, positive-controlled phase III study to evaluate the therapeutic equivalence of SYN008 versus omalizumab for injection (Xolair®) in the treatment of CSU patients who remain symptomatic despite antihistamine treatment.

Key Dates

Start date
Jul 31, 2021
Status verified
Jun 2021
Primary completion
Mar 31, 2023
Completion
Jun 30, 2023

Study Design

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

Arms

  • Experimental: SYN008
    patients received a dose of SYN008 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
  • Active Comparator: Omalizumab
    patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)

Primary Outcome Measure

The change from baseline in the Weekly Itch Severity Score (ISS7) at week 12 [ Time Frame: week 12 ]

Central Contacts

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