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: Recruiting
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged 18 to 75 years at the screening period.

• Presence of wheals with itching for ≥ 6 weeks prior to randomization. At the screening visit, subjects had taken double or more than the approved dose, or a combination of two or more H1 antihistamines for the treatment of chronic spontaneous urticaria for at least 2 weeks. Within the 7 days preceding randomization, the Urticaria Activity Score 7 (UAS7) was ≥16 (range 0-42), Itch Severity Score 7 (ISS7) was ≥8 (range 0-21), at least one UAS (range 0-6) was ≥4 on any screening visit day, and there must be a current record of medication use.

• Subjects must not miss more than one diary record (morning or night) within 7 days prior to randomization (day 1), and are willing and able to complete daily symptom electronic diary records during the study period;

• Male participants and their partners or female participants must agree to take one or more non pharmacological contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) during the trial period and within 6 months after the end of the trial and have no plans for sperm or egg donation.

• Agree to participate in this clinical trial and voluntarily sign an informed consent form.

Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Affiliated Hospital of China Medical University
RECRUITING
Beijing
The First Hospital of Peking University
RECRUITING
Beijing
The Second XiangYa Hospital of Central South University
RECRUITING
Changsha
The First Affiliated Hospital of PLA Army Medical University
RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Dermatology Hospital of Southern Medical University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Hospital of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Nanjing
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai Skin Disease Hospital
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
the Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
Contact Information
Primary
Hongzhou Yang
yanghz@longbio.com
021-58372390
Time Frame
Start Date: 2024-01-25
Estimated Completion Date: 2025-01-30
Participants
Target number of participants: 200
Treatments
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
Sponsors
Leads: Longbio Pharma

This content was sourced from clinicaltrials.gov

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