Discussing New Phase 3 Data on Nemolizumab for Prurigo Nodlaris, with Sonja Ständer, MD

New phase 3 findings on the pruriginous lesion types in patients with prurigo nodularis and the efficacy of nemolizumab (Nemluvio) were presented from the OLYMPIA 1 and 2 analyses at the American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.1

To discuss these data and their significance, given nemolizumab’s recent approval, Sonja Ständer, MD, spoke with the HCPLive team in a new interview at AAD.2 Ständer—a professor of dermatology and neurodermatology and the head of the Interdisciplinary Competence Center Chronic Pruritus (KCP) at the University Hospital Münster, Germany—was asked about the OLYMPIA trials and their significance for clinicians.

“These were the phase three trials leading to approval of nemolizumab recently, and these were two independent trials with a global presentation involving like 560 patients globally,” Ständer said. “And the patients were in 2 to 1 randomization rooted in the 2 arms, either placebo or the nemolizumab. The dose given was dependent on body weight. The patients received every 4 weeks an injection of nemolizumab, and the primary endpoint was at Week 16.”

In both trials at baseline, Ständer highlighted that all participants presented with nodules, alongside papules, plaques, ulcerations, and umbilicated lesions. She and her team found that those in the nemolizumab arm of each study showed a mean reduction from baseline of 57% and 63% in their count of pruriginous lesions within representative areas. This was compared to −6% and −25% in the placebo arm of OLYMPIA 1 and 2, respectively.1

“So nemolizumab acted very quick on the itch, and this is a primary aim of the patient. They want to get rid of the itching,” Ständer explained. “This was already observed after a couple of days, and it was well-tolerated, and this is also very important in the management of the patients.”

Ständer added that by the 16-week mark, 46% and 59% of individuals in OLYMPIA 1 and 2, respectively, who were given nemolizumab attained ≥75% lesion healing.1 She was also asked about which elements of her presentation she hopes that clinicians walk away knowing, and highlighted monitoring of the disease.

“There is 1 item, taking a look at the percentage of healed lesion,” Ständer said. “We nicely could see that, independent of patients’ IGA, this item performs very well, demonstrating that you really can see a very good healing of the lesions. At Week 16, the numbers were even higher than the IGA.”

For additional information on this data, view the full interview posted above. To find out more from AAD 2025, view our latest conference coverage.

The quotes used in this description were edited for the purposes of clarity.

Ständer has reported receiving grants, personal fees, and additional compensation from Galderma, along with grants, personal fees, and additional compensation from Sanofi, Incyte, Celldex, and Amgen.

References

1. Ständer S, Legat F, Piketty C, et al. Characterization of the pruriginous lesion types in individuals with prurigo nodularis and efficacy from the randomized, placebo-controlled, Phase 3 OLYMPIA 1&2 trials. March 7, 2025. Presented at AAD 2025.

2. Galderma Receives U.S. FDA Approval for Nemluvio® (nemolizumab) for Adult Patients Living With Prurigo Nodularis. Galderma. August 13, 2024. https://www.businesswire.com/news/home/20240812791599/en/Galderma-Receives-U.S.-FDA-Approval-for-Nemluvio%C2%AE-nemolizumab-for-Adult-Patients-Living-With-Prurigo-Nodularis. Date accessed: March 7, 2025.