Using interleukin-2 to treat chronic spontaneous urticaria
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
This study is testing if a new treatment using interleukin-2 can help adults with moderate to severe chronic hives who haven't found relief from regular allergy medicines.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | omalizumab |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06924762 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with chronic spontaneous urticaria who have been symptomatic despite treatment with second-generation antihistamines.
Not a fit: Patients who are pregnant, breastfeeding, or planning to become pregnant, as well as those who do not meet the eligibility criteria, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from chronic spontaneous urticaria who do not respond to standard antihistamine therapies.
How similar studies have performed: Previous studies have indicated that interleukin-2 may be effective for some patients with refractory chronic spontaneous urticaria, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.