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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07256392 | Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria | PHASE3 | ENROLLING BY_INVITATION | 1,370 | — | — | Nov 25, 2025 | Sep 1, 2028 | Jun 3, 2026 | 34 | United States, Australia +5 |
| NCT06455202 | A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) | PHASE3 | ACTIVE NOT_RECRUITING | 976 | — | — | Jul 19, 2024 | Apr 1, 2027 | Mar 25, 2026 | 245 | United States, Australia +20 |
| NCT06445023 | A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria | PHASE3 | ACTIVE NOT_RECRUITING | 963 | — | — | Jul 11, 2024 | Apr 1, 2027 | Mar 25, 2026 | 235 | United States, Argentina +19 |
| NCT05368285 | A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria | PHASE2 | COMPLETED | 208 | — | — | May 19, 2022 | Dec 20, 2024 | Mar 26, 2025 | 56 | United States, Bulgaria +7 |
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Evaluate duration of efficacy of barzolvolimab on urticaria activity or to a treatment related adverse event.
Evaluate duration of efficacy of barzolvolimab on urticaria activity leading to initiation of either a confounding prohibited medication (Group 1 or 2) or barzolvolimab in Group 1.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
| Arm | Type | Description |
|---|---|---|
| Group 1 Observation Group | EXPERIMENTAL | Standard of care treatment (at least 2nd generation Type 1 antihistamines \[H1AH\] with or without other permitted background medications) for 52 weeks. For participants with worsening disease (UAS7 score of 16 or greater at any time between Weeks 0-24), barzolvolimab will be administered once as a 300 mg subcutaneous injection followed by 150 mg every 4 weeks for up to 52 weeks. |
| Group 2 Barzolvolimab Retreatment Group | EXPERIMENTAL | Barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks |
| barzolvolimab 150 mg | EXPERIMENTAL | barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks |
| barzolvolimab 300 mg | EXPERIMENTAL | barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks |
| Placebo then barzolvolimab 150 mg | EXPERIMENTAL | Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks. |
| Placebo then barzolvolimab 300 mg | EXPERIMENTAL | Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks. |
| barzolvolimab 75 mg then 150 mg | EXPERIMENTAL | barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks |
| barzolvolimab 75 mg then 300 mg | EXPERIMENTAL | barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks |
| Name | Type | Description |
|---|---|---|
| barzolvolimab | BIOLOGICAL | Subcutaneous Administration |
| Standard of Care | OTHER | Observational/Standard of Care |
| Matching placebo | BIOLOGICAL | Matching placebo Subcutaneous Administration |
Key Inclusion Criteria: 1. Written informed consent 2. Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13). 3. Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and...