Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDX-0159 · 5 trials · 8 indications
Safety and tolerability of multiple dose levels of CDX-0159 as determined by drug related adverse events
Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials
Safety of a single dose of CDX-0159 as determined by adverse events
Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Placebo | PLACEBO_COMPARATOR | Normal saline administered once |
| CDX-0159 | EXPERIMENTAL | Subjects will receive a single dose of CDX-0159 |
| Normal Saline | PLACEBO_COMPARATOR | Subjects will receive a single dose of normal saline |
| Name | Type | Description |
|---|---|---|
| CDX-0159 | BIOLOGICAL | administered intravenously |
| Normal saline | DRUG | administered intravenously |
Key Inclusion Criteria: 1. Males and females, 18 - 75 years old. 2. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with: 1. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening. 2....
CDX-0159 is an investigational drug being studied for chronic spontaneous urticaria, prurigo nodularis, cold urticaria, and related conditions such as symptomatic dermographism and cholinergic urticaria. It has also been evaluated in healthy subjects. All studies completed to date are Phase 1 trials.
CDX-0159 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CLDX. The company has sponsored multiple Phase 1 clinical trials of CDX-0159 across different indications.
CDX-0159 is in Phase 1 clinical development. All four clinical trials listed for CDX-0159 are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities.
CDX-0159 has completed four Phase 1 trials: NCT04538794 in chronic spontaneous urticaria, NCT04548869 in cold contact urticaria and related conditions, NCT04944862 in prurigo nodularis, and NCT05031624 in healthy subjects. These studies were conducted in the United States, Germany, and Poland.
No, CDX-0159 is not the same as barzolvolimab. CDX-0159 is the drug name used in the clinical trials provided. No alternative names for CDX-0159 have been listed in the available information.