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New treatment option for Chronic Spontaneous Uriticaria
Official title Interleukin-2 for Refractory Chronic Spontaneous Urticaria
ClinicalTrials.gov ID: NCT06924762
What this study is testing
What is Human interleukin-2 (I) intramuscular injection?
Human interleukin-2 (I) intramuscular injection is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic spontaneous uriticaria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- 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...
- 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...
- UAS7 ≥16 on the date prior to randomization (according to complete daily symptom log data recorded in the past 7 days before randomization);
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 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 ≥16 on the date prior to randomization (according to complete daily symptom log data recorded in the past 7 days before randomization);
- Willing and able to complete daily symptom logs throughout the entire study period;
- The patient voluntarily consents to participate in this research project and has signed the informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.