CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
This study will be a single center, Phase 2, open-label trial to evaluate the safety and
efficacy of 200mg CC-11050 administered twice daily taken with food for patients with
moderate to severe ENL. The study will be performed in two steps: 1) to evaluate immediate
effect in safety and efficacy of drug in 10 males with new or new recurrent episode ENL and,
if found to be safe and effective by the DSMB and 2) if allowed by the DSMB, and approved by
relevant study stakeholders, an additional 40 ENL patients will be enrolled for up to 52
weeks of treatment. A safety analysis will be conducted on all patients who have received at
least one dose of study drug, and will include the frequency of all adverse events and
laboratory abnormalities as well as frequency of dose interruptions, dose reductions and
treatment discontinuation.