Interleukin-2 for Refractory Chronic Spontaneous Urticaria

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.

NCT Number	NCT06924762
Lead Sponsor	Second Xiangya Hospital of Central South University Collaborators: Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, West China Hospital, First Affiliated Hospital of Guangxi Medical University, Fujian Medical University Union Hospital, Second Affiliated Hospital of Guangzhou Medical University, The First People's Hospital of Changde City, The Third People's Hospital of Hangzhou
Conditions	Chronic Spontaneous Uriticaria
Enrollment	124 participants
Start Date	2025-03-19
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-11