Using interleukin-2 to treat chronic spontaneous urticaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of human interleukin-2 (IL-2) in treating adults with moderate to severe chronic spontaneous urticaria (CSU) who have not responded adequately to oral antihistamines. Participants will receive either IL-2 or a placebo through intramuscular injections over three rounds, with follow-up visits to monitor symptoms and side effects. The study will compare the outcomes of those receiving IL-2 against those receiving the placebo to determine if IL-2 can alleviate urticaria symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• the Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Hai Long, MD, PhD — Second Xiangya Hospital of Central South University
• Study coordinator: Hai Long, M.D. Ph.D.
• Email: Dr.hailong@csu.edu.cn
• Phone: 86+18229743206

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.