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.
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;
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;
Second Xiangya Hospital of Central South University
Lead sponsor
Xiangya Hospital of Central South University
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
Tongji Hospital
Collaborator
West China Hospital
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
The First People's Hospital of Changde City
Collaborator
The Third People's Hospital of Hangzhou
Collaborator