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RECRUITING

NCT06924762

PHASE2/PHASE3

Interleukin-2 for Refractory Chronic Spontaneous Urticaria

Sponsor: Second Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-03-19

Completion Date

2026-05-31

Last Updated

2025-04-11

Healthy Volunteers

Conditions

Chronic Spontaneous Uriticaria

Interventions

DRUG

Placebo intramuscular injection

On the basis of background treatment, intramuscular injection of placebo was added.

DRUG

Human interleukin-2 (I) intramuscular injection

On the basis of background treatment, intramuscular injection of human interleukin-2 (I) will be added.

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.

Locations (1)

the Second Xiangya Hospital of Central South University

Changsha, Hunan, China