Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06924762 | Interleukin-2 for Refractory Chronic Spontaneous Urticaria | PHASE2 | RECRUITING | 124 | — | — | Mar 19, 2025 | May 31, 2026 | Apr 11, 2025 | 1 | China |
This rating requires patients to record the number of wheals and the severity of itching once a day. The sum of each day's UAS score in the past seven consecutive days is UAS7.
| Arm | Type | Description |
|---|---|---|
| Interleukin-2 treatment group | EXPERIMENTAL | The enrolled subjects will receive three cycles of interleukin-2 treatment in the first 12 weeks upon initiation of the intervention, while continuing with the same oral regimen of second-generation antihistamines as they have been receiving before initiation of the trial. In each cycle of interleukin-2 treatment, the enrolled subjects will receive an intramuscular injection of interleukin-2 at a dosage of 1 million international units, dissolved in 1.0 mL of sterile water for injection, once daily for 7 consecutive days. The three cycles of interleukin-2 treatment will be administered on Day 0\~6, Day 28\~34 and Day 56\~62, respectively. |
| Placebo group | PLACEBO_COMPARATOR | The enrolled subjects will receive three cycles of placebo injections in the first 12 weeks upon initiation of the intervention, while continuing with the same oral regimen of second-generation antihistamines as they have been receiving before initiation of the trial. In each cycle of placebo injections, the enrolled subjects will receive an intramuscular injection of placebo at a same specification as in the IL-2 treatment group, dissolved in 1.0 mL of sterile water for injection, once daily for 7 consecutive days. The three cycles of placebo injections will be administered on Day 0\~6, Day 28\~34 and Day 56\~62, respectively. |
| Name | Type | Description |
|---|---|---|
| Placebo intramuscular injection | DRUG | On the basis of background treatment, intramuscular injection of placebo was added. |
| Human interleukin-2 (I) intramuscular injection | DRUG | 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...