An Observational Study Assessing the Long-term Risk of Non-Melanoma Skin Cancer (NMSC) Among New Users of OpzeluraTM (Ruxolitinib) Cream in a Vitiligo Patient Population: Post-Authorization Safety Study (PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000413
• EU PAS number:
  EUPAS1000000413
• Study ID:
  1000000413
• Official title and acronym:
  An Observational Study Assessing the Long-term Risk of Non-Melanoma Skin Cancer (NMSC) Among New Users of OpzeluraTM (Ruxolitinib) Cream in a Vitiligo Patient Population: Post-Authorization Safety Study (PASS)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United States
• Study description:
  This is a non-interventional, retrospective cohort study to evaluate the long-term risk of non-melanoma skin cancer (NMSC) among new users of Opzelura (ruxolitinib) cream in patients with vitiligo aged 12 years and older across the US, France, and Germany. Opzelura (ruxolitinib) cream is a topical formulation of ruxolitinib phosphate, an inhibitor of the janus kinase (JAK) family of protein tyrosine kinases that was recently authorized for the treatment of non-segmental vitiligo. As required by the European Medicines Agency, this study is being conducted as a post-authorization safety study (PASS) to assess the long-term risk of NMSC among new users of the Opzelura (ruxolitinib) cream for the treatment of vitiligo. The primary objective of the study is to assess the long-term risk of NMSC among patients with vitiligo treated with Opzelura (ruxolitinib) cream compared to patients with vitiligo treated with other vitiligo-related treatments. Other vitiligo-related treatments include topical calcineurin inhibitors (TCI) / topical corticosteroids (TCS) and/or phototherapy. Data is captured from two databases from US (PharMetrics Plus and US Ambulatory Electronic Medical Records [AEMR] Merged, and the Guardian Research Network [GRN] database) and two databases from the EU (German Statutory Health Insurance [SHI] and French Longitudinal Patient Data linked with French National Health Data System- Système National Des Données De Santé [SNDS]).
• Study status:
  Planned

Research institutions and networks

Institutions

Incyte Corporation

Study timelines

Date when funding contract was signed

Planned: 27/07/2023

Actual: 27/07/2023

Study start date

Planned: 18/06/2025

Data analysis start date

Planned: 11/04/2025

Date of interim report, if expected

Planned: 15/07/2025

Date of final study report

Planned: 15/07/2031

Sources of funding

More details on funding

Incyte Corporation

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)