Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as barzolvolimab
CDX-0159 · 12 trials · 11 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®
Safety and tolerability of multiple dose levels of CDX-0159 as determined by drug related adverse events
Safety of a single dose of CDX-0159 as determined by adverse events
| 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 |
| CDX-0159 1.5mg/kg | EXPERIMENTAL | CDX-0159 1.5mg/kg administered once |
| CDX-0159 3mg/kg | EXPERIMENTAL | CDX-0159 3.0 mg/kg administered once |
| CDX-0159 | EXPERIMENTAL | 20 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159 |
| Normal Saline | PLACEBO_COMPARATOR | Normal saline every 4-8 weeks |
| Name | Type | Description |
|---|---|---|
| Barzolvolimab | DRUG | Subcutaneous Administration |
| Matching Placebo | DRUG | Subcutaneous Administration |
| Standard of Care | OTHER | Observational/Standard of Care |
| CDX-0159 | BIOLOGICAL | administered intravenously |
| Normal saline | DRUG | administered intravenously |
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...
CDX-0159 is an investigational monoclonal antibody being developed by Celldex Therapeutics, Inc. for dermatologic conditions. It is in Phase 1 clinical development for chronic spontaneous urticaria, cold urticaria, and prurigo nodularis. It has been studied in completed Phase 1 trials.
CDX-0159 is being studied for the treatment of chronic spontaneous urticaria, cold urticaria, and prurigo nodularis. These are dermatologic conditions involving chronic hives or itchy skin nodules. It is investigational and has not been approved for any indication.
CDX-0159 is being developed by Celldex Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol CLDX. The company is the sponsor of the clinical trials evaluating CDX-0159 in dermatologic indications.
CDX-0159 is in Phase 1 clinical development. All three of its listed trials are Phase 1 studies, and all have been completed. The drug remains investigational and has not been approved by the FDA for any indication.
CDX-0159 has been evaluated in three completed Phase 1 trials: NCT04944862 in prurigo nodularis, NCT04548869 in cold contact urticaria, symptomatic dermographism, or cholinergic urticaria, and NCT04538794 in chronic spontaneous urticaria. These trials enrolled patients in the United States, Germany, and Poland.
Yes, CDX-0159 is also known as barzolvolimab. Both names refer to the same investigational monoclonal antibody developed by Celldex Therapeutics, Inc. for chronic spontaneous urticaria, cold urticaria, and prurigo nodularis.