Interleukin-2 for Refractory Chronic Spontaneous Urticaria
Efficacy and Safety of Interleukin-2 Treatment in Moderate to Severe Chronic Spontaneous Urticaria With Poor Control by Antihistamines: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Second Xiangya Hospital of Central South University
124 participants
Mar 19, 2025
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria7
- 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 Criteria12
- 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.
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Interventions
On the basis of background treatment, intramuscular injection of placebo was added.
On the basis of background treatment, intramuscular injection of human interleukin-2 (I) will be added.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06924762