NCT06924762 Interleukin-2 for Refractory Chronic Spontaneous Urticaria
| NCT ID | NCT06924762 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Chronic Spontaneous Uriticaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 124 participants in total. It began in 2025-03-19 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Hai Long, MD, PhD
PRINCIPAL INVESTIGATOR
Second Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT06924762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Chronic Spontaneous Uriticaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06924762 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06924762 currently recruiting?
Yes, NCT06924762 is actively recruiting participants. Contact the research team at Dr.hailong@csu.edu.cn for enrollment information.
Where is the NCT06924762 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06924762 clinical trial?
NCT06924762 is sponsored by Second Xiangya Hospital of Central South University. The principal investigator is Hai Long, MD, PhD at Second Xiangya Hospital of Central South University. The trial plans to enroll 124 participants.