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;
Parallel
Placebo intramuscular injection
DrugOn the basis of background treatment, intramuscular injection of placebo was added.
Human interleukin-2 (I) intramuscular injection
DrugOn the basis of background treatment, intramuscular injection of human interleukin-2 (I) will be added.
Change from Baseline in the Urticaria Activity Score of 7 Days（UAS7）at 12 Weeks
This rating requires patients to record the number of wheals and the severity of itching once a day. The sum of each day's UAS score in the past seven consecutive days is UAS7.
Proportion of patients who achieve the treatment target at 2, 4, 8, 12 and 24 weeks, respectively
According to the Expert Consensus on Treat⁃To⁃Target in Chronic Spontaneous Urticaria (2023), published in Chinese Journal of Dermatology, we count the proportion of CSU patients who achieve treatment targets at 2, 4, 8, 12 and 24 weeks post IL-2 or placebo intervention. As stated in Table 1 in the Expert Consensus mentioned above, a CSU patient achieves the treatment target when he meets the following criteria: (1) at 2 weeks post-intervention: UAS7 ≤6, or UAS7 decreased by ≥11 from baseline, or chronic urticaria quality of life questionnaire (CU-Q2oL) score increased by ≥8 from baseline; (2) at 4 weeks or 8 weeks: urticaria control test (UCT) score ≥12, or UAS7 ≤6, or UAS7 decreased by ≥11 from baseline, or CU-Q2oL increased by ≥8 from baseline; (3) at 12 weeks: UCT ≥12, or UAS7 ≤6, or CU-Q2oL increased by ≥19 from baseline; (4) at 24 weeks: UCT =16, or UAS7 =0, or CU-Q2oL increased by ≥19 from baseline.
The change from baseline in UAS7 at 2 weeks and 24 weeks, respectively
This rating requires patients to record the number of wheals and the severity of itching once a day. The sum of the wheal score (range 0-3 points; 0 points refer to no wheals in the day, 1 point refers to ≤ 20 wheals, 2 points refer to 20-50 wheals, and 3 points refer to ≥ 50 wheals in the day) and itching score (range 0-3 points; 0 points=none, 1 point=mild itching, 2 points=moderate itching, 3 points=severe itching) is the UAS score for the day. The sum of scores for seven consecutive days is UAS7.
Change from baseline in HSS7 score at 2, 12 and 24 weeks, respectively
This rating requires patients to record the number of wheals once daily. The sum of each day's wheal score (range 0-3 points; 0 points refer to no wheals in the day, 1 point refers to ≤ 20 wheals, 2 points refer to 20-50 wheals, and 3 points refer to ≥ 50 wheals in the day) in the past seven consecutive days is HSS7.
Change from baseline in ISS7 score at 2, 12 and 24 weeks, respectively
This rating requires patients to record the severity of itching once a day. The sum of the itching scores (range 0-3 points; 0 points=none, 1 point=mild itching, 2 points=moderate itching, 3 points=severe itching) in the past seven consecutive days is ISS7.
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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
