Technical trial results

LEO Pharma posts trial results on the public registries where the study was registered.

• Structured summary results from phase 2-4 clinical trials are posted on Clinicaltrials.gov regardless of where it was conducted in accordance with the timelines set by the US legislation. The clinical trial protocol, and as applicable the statistical analysis plan, are posted for phase 2-4 clinical trials alongside the structured summary results on the ClinicalTrials.gov.
• For studies included in the EU Clinical Trial Register, structured summary results are submitted within 12 months of trial completion (6 months for pediatric studies).
• For studies included in the EU Clinical Trial information System (CTIS), a summary of the results are submitted within 12 months of trial completion (6 months for pediatric studies) and made public in accordance with the EU Clinical Trials Regulation.
• In local registries, where required.

LEO Pharma posts scientific synopses for all phase 1-4 interventional trials, approximately 1 year after the end of the trial. Scientific synopses are available for trials that have started since 1990, including trials from discontinued projects.