Celldex halts skin disease program after barzolvolimab fails phase 2 trial

Celldex Therapeutics announced it is discontinuing development of its anti‑KIT antibody barzolvolimab for chronic skin disorders after the drug failed to meet its primary endpoint in a phase 2 study.

The trial, which targeted prurigo nodularis, evaluated itch reduction at week 12 and did not show a statistically significant improvement versus placebo. Secondary measures also fell short, despite evidence of systemic mast cell depletion.

The company had previously advanced barzolvolimab into phase 3 trials for chronic spontaneous urticaria and cold urticaria and was testing it in atopic dermatitis and prurigo nodularis. The phase 2 failure raises concerns about an upcoming readout for an eczema indication.

Analysts noted that a change in administration from intravenous in earlier studies to subcutaneous in the phase 2 trial may have contributed to the lack of efficacy, and the setback could impact Celldex’s broader mast‑cell depletion strategy.