LEO Pharma advances Anzupgo® (delgocitinib) cream to phase 3 trial in lichen sclerosus (LS)

• The phase 3 trial DELTA CARE 1 will recruit up to 652 adult patients with lichen sclerosus (LS) to investigate the efficacy and safety of delgocitinib cream compared to cream vehicle.¹
• The study initiation in LS is part of LEO Pharma’s ambition to explore Anzupgo (delgocitinib) cream in additional indications beyond Chronic Hand Eczema (CHE), investigating the potential of delgocitinib as treatment option in skin diseases with high unmet medical need. There are currently no approved treatments specifically indicated for LS in the U.S. or in Europe.
• Delgocitinib cream has been shown to inhibit the activity of all four JAKs,^2,3 making it a potential treatment option for people living with LS disease.

BALLERUP, Denmark–(BUSINESS WIRE)–NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, announced today the initiation of the phase 3 DELTA CARE 1 trial. The trial aims to evaluate the efficacy and safety of delgocitinib cream compared to cream vehicle for the treatment of adults with mild to severe lichen sclerosus (LS).¹

“By investigating the expansion of the indication for delgocitinib, LEO Pharma is taking another important step toward addressing high unmet needs in medical dermatology, while advancing our ambition to lead research in delgocitinib for dermatological diseases and supporting future growth,” said Sophie Lamle, Executive Vice President, Development, LEO Pharma. “There are currently no approved treatments in the U.S. or in Europe specifically for LS – a disease with a high burden on quality of life. We are committed to developing innovative solutions that can make a fundamental difference in their lives, and we are excited to further explore the potential of delgocitinib in this burdensome disease.”

Anzupgo is currently approved in the U.S., the EU, and several other markets for adult patients with moderate to severe chronic hand eczema (CHE)^4,5. LEO Pharma is now investigating LS and exploring additional disease areas, where delgocitinib could address significant unmet medical needs.

LS is an inflammatory skin disease that typically affects the anogenital area where it can cause itching, soreness, architectural changes and scarring, with a significant impact on the quality of life of affected patients.⁵ LS may lead to sexual and urinary dysfunction in both women and men.⁵

“Persistent itching, soreness, and the risk of permanent scarring can severely affect quality of life, particularly for women, where LS is far more prevalent,” said Jacob Thyssen, Executive Vice President, Chief Scientific Officer, LEO Pharma. “The currently no approved treatments specifically indicated for LS is leaving many patients with limited options and highlighting the need for new therapies.”

Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor shown to inhibit the activity of all four JAKs, which are involved in inflammatory signaling.^2,3 This trial will be the first to investigate the potential beneficial effects of a pan-JAK inhibitor for the treatment of LS.

The DELTA CARE 1 trial plans to recruit up to 652 adult patients with LS, beginning with the recruitment of 300 female patients to investigate the optimal dose. The selected dose will then be evaluated against cream vehicle in up to 352 additional female and male participants.¹ Participants will be recruited across 80-90 sites in the United States, Canada, the UK, Germany, Frace, Italy, Spain and Poland.

For more information on the DELTA CARE 1 trial, go to clinicaltrials.gov.

About lichen sclerosus (LS)

Lichen sclerosus (LS) is a chronic, inflammatory skin condition that can affect people of all ages and both sexes, but is far more common in women than men, with a female-to-male ratio of 3:1 to 10:1.⁷ In women, LS often appears in two age peaks – in childhood before puberty and again around or after menopause – while in men it more often develops in young adulthood or later in life after the age of 60.⁷

LS can cause white patches of skin, itching, soreness, architectural changes and scarring, leading to urinary problems, and other functional challenges. These symptoms can have a profound effect on quality of life, impacting daily activities, emotional wellbeing, and sexual health.⁷

About Anzupgo^® (delgocitinib) cream

Anzupgo^® cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.⁸

Anzupgo^® is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo^® cream is also under investigation in other markets.

Anzupgo^® (delgocitinib) cream is FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Use of Anzupgo^® in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA.⁵

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the rights.

About the DELTA CARE 1 Trial

DELTA CARE 1 is a 52-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group, multi-site trial to investigate the efficacy and safety of a twice-daily application of delgocitinib cream compared with cream vehicle in adults with lichen sclerosus (LS).¹

The trial has an adaptive design, first enrolling 300 female participants randomized to receive either cream vehicle, 8 mg/g delgocitinib cream, or 20 mg/g delgocitinib cream. After these participants reach the primary endpoint, a blinded data monitoring committee will determine the optimal dose based on pre‑specified criteria. The selected dose will then be evaluated against cream vehicle in up to 352 additional female and male participants.¹

The primary endpoint of DELTA CARE 1 is the Investigator’s Global Assessment for LS treatment success (IGA-LS TS) after 12 weeks. Treatment success is defined as an IGA-LS score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. After 12 weeks, the participants will be re-randomized to delgocitinib cream or cream vehicle for an additional 40 weeks.¹

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin.

For more information, visit www.leo-pharma.com.

References

1. ClinicalTrials.gov. National Library of Medicine (U.S.). A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants with Lichen Sclerosus (DELTA CARE 1). Identifier: NCT07335588. https://clinicaltrials.gov/study/NCT07335588
2. Tanimoto A, Ogawa Y, Oki C, et al. Pharmacological properties of JTE-052: a novel potent JAK inhibitor that suppresses various inflammatory responses in vitro and in vivo. Inflamm Res. 2015;64(1):41-51.
3. Tanimoto A, Shinozaki Y, Yamamoto Y, et al. A novel JAK inhibitor JTE-052 reduces skin inflammation and ameliorates chronic dermatitis in rodent models: Comparison with conventional therapeutic agents. Exp Dermatol. 2018;27(1):22-29.
4. European Medicines Agency. Anzupgo 20 mg/g cream: summary of product characteristics. Amsterdam: EMA; 2024 [updated 2025 Jan 22; cited 2026 Jan 20]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo
5. ANZUPGO^® (delgocitinib) cream. Prescribing Information. FDA. July 2025.
6. Kirtschig G, Kinberger M, Kreuter A, et al. EuroGuiDerm guideline: Lichen sclerosus. European Dermatology Forum. 2023;1-128. Available from: https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdv.20083
7. De Luca DA, Papara C, Vorobyev A, Staiger H, Bieber K, Thaçi D, Ludwig RJ. Lichen sclerosus: The 2023 update. Front Med. 2023;10:1106318. doi:10.3389/fmed.2023.1106318. Available from: https://www.frontiersin.org/articles/10.3389/fmed.2023.1106318/full
8. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.

MAT-90445 January 2026

Contacts

Jes Broe Frederiksen

Global Corporate Communication

+45 53 60 59 48

jebfe@leo-pharma.com

Christian Bundgaard

Global Corporate Communication

+45 53 74 88 49

chbun@leo-pharma.com