Status:
RECRUITING
Interleukin-2 for Refractory Chronic Spontaneous Urticaria
Lead Sponsor:
Second Xiangya Hospital of Central South University
Collaborating Sponsors:
Xiangya Hospital of Central South University
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Chronic Spontaneous Uriticaria
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to learn if human interleukin-2 (IL-2) works to treat moderate to severe chronic spontaneous urticaria in adults who remain symptomatic despite oral antihistamine tr...
Detailed Description
Background: Urticaria is a common disorder characterized by localized edema due to dilation and increased permeability of small blood vessels in the skin and mucous membranes. The primary clinical ma...
Eligibility Criteria
Inclusion
- Gender: Not limited; Age: at least 18 years old and less than 75 years old;
- Diagnosed with chronic spontaneous urticaria (CSU) (including patients overlapped with chronic inducible urticaria) according to the 2021 EAACI/GA²LEN/EDF/AAAAI guidelines;
- Disease course of CSU for at least 12 weeks;
- The patient has been treated with second-generation antihistamines (one or more types, up to 4 tablets per day) every day for 2 weeks or more but still experiences significant symptoms of wheals and/or itching, with a UAS7 score ≥16 or a UCT score \<12;
- UAS7 ≥16 on the date prior to randomization (according to complete daily symptom log data recorded in the past 7 days before randomization);
- Willing and able to complete daily symptom logs throughout the entire study period;
- The patient voluntarily consents to participate in this research project and has signed the informed consent.
Exclusion
- Pregnant or breastfeeding women, or women planning to conceive within 6 months;
- Has used corticosteroids, immunosuppressants, leukotriene receptor antagonists, H2 receptor antagonists, intravenous immunoglobulin (IVIG) therapy, and/or undergone plasma exchange in the past 4 weeks;
- Has received omalizumab or other biologic treatments in the past 12 weeks;
- Has previously undergone interleukin-2 treatment;
- Has a history of anaphylactic shock;
- Plans or anticipates the use of any prohibited drugs or treatments during the screening and/or treatment periods;
- Currently has active or recurrent severe infections, such as active tuberculosis;
- Has a congenital or acquired immunodeficiency disorder;
- Has a history of drug or alcohol abuse, mental disorders, or poor compliance, making them unable to adhere to treatment;
- Currently enrolled in another clinical trial;
- Is an employee of the clinical research facility or directly involved in the study, or is an immediate family member of such an individual;
- Any other reason that makes participation in this trial inappropriate.
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06924762
Start Date
March 19 2025
End Date
May 31 2026
Last Update
April 11 2025
Active Locations (1)
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1
the Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000