NCT03807362

CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum

A Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of CC-11050 in Nepalese Patients With Erythema Nodosum Leprosum

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Leprosy Mission Nepal · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erythema Nodosum Leprosum
• Leprosy

Interventions

Type	Name	Description
DRUG	CC-11050	CC-11050 is a novel anti-inflammatory compound with potential to treat a variety of chronic inflammatory conditions.

Timeline

• Start date: 2018-01-07
• Primary completion: 2021-03-30
• Completion: 2024-12-31
• First posted: 2019-01-16
• Last updated: 2020-07-07

Locations

2 sites across 1 country: Nepal