Delgocitinib Advances to Phase 3 Evaluation for Lichen Sclerosus

LEO Pharma recently announced that it has initiated a phase 3 clinical program evaluating delgocitinib cream (Anzupgo) for the treatment of lichen sclerosus (LS), marking a significant development in a disease area with substantial unmet therapeutic need. The DELTA CARE 1 trial (NCT07335588) will assess the efficacy and safety of delgocitinib cream compared with vehicle in adults with mild to severe LS.¹

LS is a chronic inflammatory dermatosis that most commonly affects the anogenital region and is associated with pruritus, soreness, architectural distortion, and progressive scarring. The disease carries a considerable quality-of-life burden and may lead to sexual and urinary dysfunction in both women and men. Despite its clinical impact, there are currently no treatments approved in the US or Europe specifically indicated for LS, with management relying largely on off-label use of high-potency topical corticosteroids.¹

Specifically, women who may develop vulvar LS are at risk of ecchymoses, resorption of the labia, narrowing of the introitus, and distortion of the vulvar architecture. If vulvar LS is left untreated, it can progress with an increased risk of vulvar squamous cell carcinoma. Although there is no cure for LS, high-potency topical corticosteroids have been considered first-line treatments.²

"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 and Chief Scientific Officer of LEO Pharma, in the news release. "The currently no approved treatments specifically indicated for LS is leaving many patients with limited options and highlighting the need for new therapies."

DELTA CARE 1 is a 52-week, randomized, double-blind, vehicle-controlled, parallel-group, multicenter phase 3 trial designed to enroll up to 652 adult participants with LS. Recruitment will span approximately 80 to 90 sites across North America and Europe, including the US, Canada, the United Kingdom, Germany, France, Italy, Spain, and Poland. The trial employs an adaptive design, beginning with the enrollment of 300 women to evaluate 2 dose strengths of delgocitinib cream—8 mg/g and 20 mg/g—against vehicle. Following assessment of the primary end point, a blinded data monitoring committee will select the optimal dose for evaluation in an additional cohort of up to 352 women and men.

The primary end point is Investigator’s Global Assessment for LS treatment success (IGA-LS TS) at week 12, defined as an IGA-LS score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline. After the initial 12-week treatment period, participants will be re-randomized to receive delgocitinib cream or vehicle for an additional 40 weeks to further characterize long-term safety and durability of response.

Delgocitinib is a topical pan–Janus kinase (JAK) inhibitor that targets all 4 JAK isoforms involved in inflammatory signaling pathways. While JAK inhibition has been extensively explored in other inflammatory dermatoses, DELTA CARE 1 represents the first phase 3 investigation of a pan-JAK inhibitor specifically for LS. The mechanistic rationale is supported by the role of JAK-STAT signaling in cutaneous inflammation and immune dysregulation.

Delgocitinib cream is approved in multiple regions, including the US and European Union, for the treatment of moderate to severe chronic hand eczema in adults who have had an inadequate response to topical corticosteroids or for whom such therapies are not advisable.³

If successful, DELTA CARE 1 could represent an important step toward establishing the first approved, nonsteroidal topical therapy specifically indicated for LS, with potential implications for long-term disease control and quality-of-life outcomes in this underserved patient population.

References

1. LEO Pharma advances Anzupgo (delgocitinib) cream to phase 3 trial in lichen sclerosus (LS). News release. LEO Pharma. January 21, 2026. Accessed January 21, 2026. https://www.leo-pharma.com/media-center/news/2026-delgocitinib-ls-trial-initiation
2. Leis M, Singh A, Li C, Ahluwalia R, Fleming P, Lynde CW. Risk of vulvar squamous cell carcinoma in lichen sclerosus and lichen planus: a systematic review. J Obstet Gynaecol Can. 2022;44:182–92. doi: 10.1016/J.JOGC.2021.09.023.
3. Anzupgo (delgocitinib) cream is now the first and only FDA-approved treatment for moderate-to-severe chronic hand eczema (CHE) in adults. News release. LEO Pharma Inc. July 23, 2025. Accessed January 21, 2025. https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults