First Patient Enrolled in Nemolizumab Study for Chronic Itch Without Cause

Key Takeaways

• Galderma has initiated a phase II study evaluating nemolizumab in adults with CPUO.

• CPUO has no approved therapies and is linked to IL-31-mediated chronic itch.

• The trial builds on emerging data and nemolizumab’s efficacy in related dermatologic conditions.

Galderma announced the enrollment  first patient in a phase II clinical trial investigating nemolizumab for the treatment of Chronic Pruritus of Unknown Origin (CPUO), according to a press release from the manufacturer.

The trial is being conducted in the United States, with the first enrollment occurring at the site of Vlada Groysman, MD, in Birmingham, Alabama. Previously approved for atopic dermatitis (AD) and prurigo nodularis, nemolizumab has  showed efficacy in itch reduction and inflammation control across conditions where IL-31 is central to pathogenesis, according to the news release. The current double-blind, placebo-controlled trial wil evaluate the safety and efficacy of nemolizumab in CPUO, supporting future late-stage development.

“Nemolizumab has shown outstanding efficacy in prurigo nodularis—a condition that shares important clinical and mechanistic features with CPUO,” said Shawn Kwatra, MD, lead investigator, in the press release. “We’re hopeful that nemolizumab could offer meaningful relief to patients with this condition.”

Galderma’s study builds on recent mechanistic insights presented at the 2025 Society of Investigative Dermatology meeting that showed IL-31-producing CD4+ T cells in CPUO, reinforcing the rationale for IL-31-targeted therapy.

“The first patient enrollment in this study marks an important milestone in our commitment to advancing dermatology for every skin story,” said Baldo Scassellati Sforzolini, MD, PhD, Galderma’s Global Head of R&D, in the press release. “We’re hopeful this study will pave the way for a new therapeutic approach for those living with CPUO.”