Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
barzolvolimab · 9 trials · 8 indications
Proportion of Cold Induced Urticaria \[ColdU\] participants with complete response in Critical Temperature Threshold (CTT) or proportion of Symptomatic Dermographism \[SD\] participants with complete response in Critical Friction Threshold at Week 12. * For ColdU patients, a complete response is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a complete response test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
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.
Evaluate the clinical efficacy of 2 dose levels (150 mg and 300 mg) of barzolvolimab, compared to placebo, in adult participants with moderate to severe atopic dermatitis (AD) using the PP-NRS. The PP-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hr period.
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
Peak esophageal intraepithelial mast cell counts will be determined by counting mast cells in the most inflamed high-power field (hpf) of each of the 3 esophageal (proximal, mid, distal) levels and reported as mast cells/hpf.
Percentage of patients with a negative provocation test for Cold Inducible Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) at week 12 * For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
| Arm | Type | Description |
|---|---|---|
| barzolvolimab in patients with Cold Induced Urticaria | EXPERIMENTAL | barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
| Placebo in patients with Cold Induced Urticaria | PLACEBO_COMPARATOR | Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
| barzolvolimab in patients with Symptomatic Dermographism | EXPERIMENTAL | barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
| Placebo in patients with Symptomatic Dermographism | PLACEBO_COMPARATOR | Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
| 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 450 mg, then 150 mg Q4W | EXPERIMENTAL | 450 mg subcutaneous administration loading dose on Day 1 followed by 150 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. |
| Barzolvolimab 450 mg, then 300 mg Q4W | EXPERIMENTAL | 450 mg subcutaneous administration loading dose on Day 1 followed by 300 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. |
| Barzolvolimab (CDX-0159) | ACTIVE_COMPARATOR | 300 mg subcutaneous administration every 4 weeks through week 24 |
| Placebo then barzolvolimab (CDX-0159) 300mg | PLACEBO_COMPARATOR | Matching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24 |
| barzolvolimab 150 mg in patients with Symptomatic Dermographism | EXPERIMENTAL | barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks |
| barzolvolimab 300 mg in patients with Symptomatic Dermographism | EXPERIMENTAL | barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks |
| Placebo Comparator in patients with Symptomatic Dermographism | PLACEBO_COMPARATOR | Placebo injection subcutaneous every 4 weeks for 20 weeks |
| barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria | EXPERIMENTAL | barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks |
| barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria | EXPERIMENTAL | barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks |
| Placebo Comparator in patients with Chronic Inducible Cold Urticaria | PLACEBO_COMPARATOR | Placebo injection subcutaneous every 4 weeks for 20 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 | DRUG | Subcutaneous Administration |
| Matching Placebo | DRUG | Subcutaneous Administration |
| Standard of Care | OTHER | Observational/Standard of Care |
Key Inclusion Criteria: 1. Males and females, \>/= 18 years of age. 2. Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months. 3. Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihis...