Business Wire

Galderma Phase III Data Published in the New England Journal of Medicine: Full OLYMPIA 2 Trial Results Demonstrate Nemolizumab’s Rapid Onset of Action in Prurigo Nodularis Patients


Galderma today announced that the New England Journal of Medicine has published full results from the phase III OLYMPIA 2 trial evaluating the efficacy and safety of nemolizumab monotherapy in adults with prurigo nodularis. The trial met both primary and all key secondary endpoints, demonstrating that nemolizumab-treated patients had significantly higher improvements in itch and skin lesions when compared to those receiving placebo, with a rapid and clinically meaningful response on itch, observed as early as week 4. Nemolizumab was well tolerated, and its safety profile was consistent with phase II trial results.1

This press release features multimedia. View the full release here:

“We are proud that the clinical trial results of nemolizumab in prurigo nodularis have been published in the prestigious New England Journal of Medicine for a second time, which is testament to the robustness of our scientific method and quality of evidence supporting its efficacy. We believe nemolizumab has the potential to be a rapidly effective treatment option for patients with prurigo nodularis, with improvements on itch and skin lesions observed as early as week 4.”


The phase III OLYMPIA 2 trial enrolled 274 adult patients with moderate to severe prurigo nodularis. Results demonstrated that patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically meaningful and statistically significant improvements in both primary endpoints, compared to placebo, after 16 weeks of treatment:

  • More than twice as many nemolizumab-treated patients achieved an at least four-point improvement in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS), when compared to the placebo group (56.3% vs 20.9%; p<0.0001).
  • More than three times as many nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment score, compared to the placebo group (37.7% vs 11.0%; p<0.0001).

The trial also met all key secondary endpoints confirming rapid responses on itch and sleep disturbance as early as week 4:

  • More than five times as many nemolizumab-treated patients achieved itch response when compared to the placebo group (41.0% vs 7.7%; p<0.001), as measured by a four-point or greater reduction in PP-NRS score.
  • More than eight times as many patients achieved a PP-NRS score of less than two, when compared to the placebo group (19.7% vs 2.2%; p<0.001). Results improved through to week 16 (35.0% vs 7.7%; p<0.001).
  • More than three times as many nemolizumab-treated patients demonstrated a four-point improvement in sleep disturbance, as measured by the sleep disturbance numerical rating scale, when compared to the placebo group (37.2% vs 9.9%; p<0.001). Results improved through to week 16 (51.9% vs 20.9%; p<0.001).

Nemolizumab is an investigational monoclonal antibody specifically designed to target the IL-31 receptor and inhibit IL-31 signaling. IL-31 plays a key role in multiple disease mechanisms in prurigo nodularis, including itch signaling, epidermal changes and fibrosis.3-7 This includes directly addressing the source of itch, which causes sleep disturbance and negatively impacts quality of life outcomes.4-8

“Chronic itch is by far the most burdensome symptom for patients with prurigo nodularis, and this is often poorly controlled. The fact that nemolizumab – by inhibiting IL-31 signaling – has the potential to provide a new treatment type that rapidly improves both itch and skin lesions is exciting news.”


Galderma is investigating the use of nemolizumab and has not received approval in any jurisdiction for any indication. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of itch associated with prurigo nodularis, a status reconfirmed in March 2023. Results from the phase III OLYMPIA 2 trial will be submitted to selected health authorities around the world.

To learn more about prurigo nodularis, watch this video from the New England Journal of Medicine. Media can also find more information via the prurigo nodularis media toolkit.

About prurigo nodularis
Prurigo nodularis is a debilitating chronic skin condition characterized by thick skin nodules covering large body areas and associated with intense itch (pruritus).3,9-10 Prurigo nodularis affects an estimated 72 out of every 100,000 adults aged 18 to 64 in the United States. It is more common in middle-aged women and, disproportionately, people of African descent.3,11

About nemolizumab
Nemolizumab is in clinical development for the treatment of atopic dermatitis and prurigo nodularis in many countries around the world. It was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis.

About the OLYMPIA 2 trial
OLYMPIA 2 was a randomized, double-blind, placebo-controlled phase III clinical trial designed to assess the efficacy and safety of nemolizumab monotherapy compared with placebo in patients aged at least 18 with prurigo nodularis after a 16-week treatment period. The trial also assessed the pharmacokinetics and immunogenicity of nemolizumab compared to placebo. OLYMPIA 2 included 274 patients with moderate to severe prurigo nodularis.

About Galderma
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information:


  1. Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. DOI: 10.1056/NEJMoa2301333
  2. Ständer S, et al. Trial of nemolizumab in moderate-to-severe prurigo nodularis. N Engl J Med. 2020; 382:706-716. DOI:10.1056/NEJMoa1908316
  3. Williams KA, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14(1):67-77. DOI:10.1080/17512433.2021.1852080
  4. Nemmer JM, et al. Interleukin-31 signaling bridges the gap between immune cells, the nervous system and epithelial tissues. Front Med (Lausanne). 2021;8:639097. DOI:10.3389/fmed.2021.639097
  5. Wang F, Kim BS. Itch: a paradigm of neuroimmune crosstalk. Immunity. 2020;52(5):753-766. DOI:10.1016/j.immuni.2020.04.008
  6. Zhang Q, et al. Structures and biological functions of IL-31 and IL-31 receptors. Cytokine Growth Factor Rev. 2008;19(5-6):347-356. DOI:10.1016/j.cytogfr.2008.08.003
  7. Tsoi LC, et al. Transcriptomic characterization of prurigo nodularis and the therapeutic response to nemolizumab. J Allergy Clin Immunol. 2021;S0091-6749(21)01557-8. DOI:10.1016/j.jaci.2021.10.004
  8. Gwillim EC, Nattkemper L, Yosipovitch G. Impact of itch on sleep disturbance in patients with prurigo nodularis. Acta Derm Venereol. 2021;101(3):adv00424. DOI:10.2340/00015555-3778. PMID: 33704503
  9. Elmariah S, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84(3):747-760. DOI:10.1016/j.jaad.2020.07.025
  10. Whang KA, et al. Prevalence of prurigo nodularis in the United States. J Allergy Clin Immunol Pract. 2020;8(9):3240-3241. DOI:10.1016/j.jaip.2020.05.051
  11. Huang AH, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. DOI:10.1016/j.jid.2019.07.697

To view this piece of content from, please give your consent at the top of this page.

Contact information

Christian Marcoux, M.Sc.
Chief Communications Officer
+41 76 315 26 50

Sébastien Cros
Corporate Communications Director
+41 79 529 59 85

Emil Ivanov
Head of Strategy, Investor Relations, and ESG
+41 21 642 78 12

Jessica Cohen
Investor Relations and Strategy Director
+41 21 642 76 43

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

V-Nova completes the acquisition of Parallaxter Srl, the company behind the PresenZ XR technology29.11.2023 10:00:00 CET | Press release

V-Nova, a leading provider of data compression solutions, announces the full acquisition of Parallaxter Srl, completing its prior investments in the company and incorporating it into the V-Nova group. Parallaxter are the XR experts behind the PresenZ technology and this acquisition will greatly expand V-Nova’s portfolio of IP and technologies in VR/XR and gaming, as well as further strengthen its position in the data and video compression industry. V-Nova PresenZ, a Lumiere Award winning format that combines Parallaxter's PresenZ technology and V-Nova's point-cloud compression, is set to revolutionize storytelling in VR. It offers users cinematic photorealism and 6DoF for real-time navigation in pre-rendered scenes, breaking free from static viewpoints and ensuring full immersiveness. V-Nova PresenZ is distributed at scale also to stand-alone XR devices thanks to MPEG-5 LCEVC enhanced pixel streaming. The format dovetails with standard Computer Graphics and Special FX production workfl

PUMA RE:SUEDE Pilot Project Turns Experimental Sneakers Into Compost29.11.2023 09:29:00 CET | Press release

Sports company PUMA showed that it can successfully turn an experimental version of its classic SUEDE sneaker into compost under certain tailor-made industrial conditions, as it announced the results of its two-year-long RE:SUEDE experiment. This press release features multimedia. View the full release here: Sports company PUMA showed that it can successfully turn an experimental version of its classic SUEDE sneaker into compost under certain tailor-made industrial conditions, as it announced the results of its two year-long RE:SUEDE experiment. (Photo: Business Wire) In 2021, PUMA created 500 pairs of the experimental RE:SUEDE, using Zeology tanned suede, a TPE outsole and hemp fibres. The RE:SUEDEs were worn for half a year by volunteers in Germany to test the comfort and durability of the shoes before PUMA sent them to a specially equipped industrial composting area operated by its partner Ortessa Group in the Netherlands. A

Matmut Selects Earnix to Deliver Comprehensive Modeling, Pricing, and Rating Engine29.11.2023 09:00:00 CET | Press release

Earnix, the global provider of AI-based SaaS solutions for insurers and banks, today announced that Matmut, a major mutual insurer in France, has chosen, and is now working with, Earnix as its partner. Matmut is one of France's leading property and casualty insurers, offering a range of personal and commercial insurance products. Earnix solutions address Matmut's business and IT needs by integrating easily into its tech stack, enabling rapid pricing adjustments. With Earnix, Matmut can seamlessly integrate machine learning models as part of its pricing strategy. This enables Matmut to not only build, test, and deploy rates into the market with ease, but also benefit from automation, governance, and auditability. Emeric Bellanger, Technical Director of Claims and Pricing at Matmut said, “This partnership empowers our pricing team to provide top leaders with recommended pricing changes based on simulation and the ability to implement these changes more easily." Earnix solutions enable ne

Global Healthcare Leaders Advance Sector Decarbonisation Ahead of COP2829.11.2023 08:00:00 CET | Press release

To accelerate the transition to net zero health systems, global healthcare leaders from the Sustainable Markets Initiative Health Systems Task Force are in advanced discussions with energy providers in China and India to scale renewable power across their supply chains. This is the first time that companies from across the global healthcare sector – including AstraZeneca, GSK, Novo Nordisk, Roche – have come together to pioneer such initiatives in these countries. China and India are key markets for pharmaceuticals manufacturing, estimated to account for up to 50% of materials for medicines.i This press release features multimedia. View the full release here: Air pollution over Shanghai illustrating the climate health crisis. (Photo: Business Wire) In China, the power agreements would unlock renewable energy in Jiangsu, Guangdong, Shanghai and Beijing. The agreements are set to bring around 70 megawatts (MW) of renewable power a

Capcom Reveals Dragon’s Dogma 2 Scheduled to Launch March 22, 2024!29.11.2023 02:00:00 CET | Press release

Capcom Co., Ltd. (TOKYO:9697) today announced that Dragon’s Dogma 2, the latest game in the Dragon’s Dogma series, is scheduled to be released on March 22, 2024. With the launch of Dragon’s Dogma 2, Capcom closes out a stellar year of major title releases for its 2023 fiscal year. This press release features multimedia. View the full release here: Dragon's Dogma 2 is a single player, narrative driven action-RPG and the latest title in the Dragon’s Dogma series. The game features intricately crafted, gorgeous visuals powered by Capcom’s proprietary RE ENGINE that elevate its unique gameplay experience to provide a truly immersive fantasy world sure to delight both newcomers as well as long-time fans of the series. (Graphic: Business Wire) Dragon’s Dogma 2 is the latest title in the series, and the first mainline entry since the original Dragon’s Dogma was released in 2012. The game is being developed on Capcom’s proprietary RE EN