The first patient has been dosed in Celldex Therapeutics, Inc.’s Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN).
Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell. Mast cells are believed to play an important role in amplifying chronic itch and neuroinflammation, including in PN where mast cells are associated with pruritic sensory neurons in PN lesions.
In November 2023, Celldex presented first-in-class data from its Phase 1b study in PN demonstrating that barzolvolimab and its novel mast cell depleting mechanism could play a meaningful role in breaking the stubborn scratch/itch cycle of this disease, resulting in lesion healing.
The randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of 2 dose levels of barzolvolimab compared to placebo in approximately 120 patients with moderate to severe PN who had inadequate response to prescription topical medications, or for whom topical medications are medically inadvisable (such as concerns for safety), including patients who received prior biologics. Patients will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab injections of 150 mg Q4W after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo during a 24‑week treatment phase. Participants will then enter a follow-up phase with no study treatment for an additional 16 weeks through week 40.
The primary objective of this study is to evaluate the clinical effect of barzolvolimab, compared to placebo, on itch response as measured by the proportion of participants with ≥ 4-point improvement in the worst intensity itch per a numeric rating scale (WI-NRS). Secondary objectives include but are not limited to additional measures of itch response from baseline compared to different timepoints, the assessment of skin lesions as measured by the Investigator Global Assessment (IGA), QoL outcomes and safety. The study will include approximately 50 clinical trial centers worldwide, including the United States.
PHOTO CREDIT: DermNet
