💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Gender: Not limited; Age: at least 18 years old and less than 75 years old;
2. Diagnosed with chronic spontaneous urticaria (CSU) (including patients overlapped with chronic inducible urticaria) according to the 2021 EAACI/GA²LEN/EDF/AAAAI guidelines;
3. Disease course of CSU for at least 12 weeks;
4. 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;
5. UAS7 ≥16 on the date prior to randomization (according to complete daily symptom log data recorded in the past 7 days before randomization);
6. Willing and able to complete daily symptom logs throughout the entire study period;
7. The patient voluntarily consents to participate in this research project and has signed the informed consent.
Exclusion Criteria:
* 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.
💊
What it tests
- Placebo intramuscular injection
- Human interleukin-2 (I) intramuscular injection
the Second Xiangya Hospital of Central South University
Changsha, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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