Actively Recruiting
Interleukin-2 for Refractory Chronic Spontaneous Urticaria
Led by Second Xiangya Hospital of Central South University · Updated on 2025-04-11
124
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
Sponsors
S
Second Xiangya Hospital of Central South University
Lead Sponsor
X
Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 treatment (refractory CSU). It will also learn about the safety of IL-2. The main questions it aims to answer are: Does IL-2 alleviate the symptoms of urticaria in patients? What medical problems do participants have when given IL-2? Researchers will compare IL-2 to a placebo (a look-alike and smell-like substance that contains no IL-2) to see if IL-2 works to treat refractory, moderate to severe CSU. Participants will: Receive IL-2 or a placebo intramuscular injections for 3 rounds at Week 0, 4 and 8, in which each round includes one injection daily for seven consecutive days. Visit the clinic for checkups and tests at Week 2, 4, 8, 12 and 24. Keep a diary of their symptoms and the number of tablets of oral antihistamines.
CONDITIONS
Official Title
Interleukin-2 for Refractory Chronic Spontaneous Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of any gender aged 18 years or older and less than 75 years old
- Diagnosed with chronic spontaneous urticaria (CSU) based on 2021 EAACI/GA²LEN/EDF/AAAAI guidelines
- CSU symptoms lasting for at least 12 weeks
- Treated with second-generation antihistamines daily for 2 or more weeks but still experiencing significant wheals and/or itching
- Urticaria Activity Score over 7 days (UAS7) of 16 or higher prior to randomization
- Willing and able to maintain daily symptom logs throughout the study
- Provided informed consent voluntarily
You will not qualify if you...
- Pregnant or breastfeeding women, or planning to conceive within 6 months
- Used corticosteroids, immunosuppressants, leukotriene receptor antagonists, H2 receptor antagonists, intravenous immunoglobulin (IVIG) therapy, or plasma exchange in the past 4 weeks
- Received omalizumab or other biologic treatments in the past 12 weeks
- Previously treated with interleukin-2
- History of anaphylactic shock
- Plans to use prohibited drugs or treatments during screening or treatment
- Active or recurrent severe infections such as active tuberculosis
- Congenital or acquired immunodeficiency disorders
- History of drug or alcohol abuse, mental disorders, or poor treatment compliance
- Currently enrolled in another clinical trial
- Employed by the clinical research facility, involved in the study, or immediate family member of such individuals
- Any other reasons making participation inappropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
the Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
H
Hai Long, M.D. Ph.D.
CONTACT
G
Guishao Tang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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