Title
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
Phase
Phase 2Lead Sponsor
The Leprosy Mission NepalStudy Type
InterventionalStatus
RecruitingIndication/Condition
Leprosy Erythema Nodosum LeprosumIntervention/Treatment
CC-11050Study Participants
50This 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.
200mg CC-11050 will be administered twice daily as a pill taken with food (at breakfast and evening meal) for participants with moderate to severe ENL for 10 days, then up to 28 days (during Step 1) and then up to 1 year (during Step 2).
Inclusion Criteria: Study participants must satisfy the following criteria to be enrolled in the study: Must be 18 -65 years old, weight > 35kg for women and >40kg for men at the time of signing the informed consent. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. Have signs or symptoms of new or new episode ENL. In Step one, participants must be male. In Step 2, participants can be either male or female. Able to adhere to the study schedule and other protocol requirements. Exclusion Criteria: The presence of any of the following will exclude a participant from enrollment: Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study. Patients on continuous rifampicin will be excluded, however, If rifampicin is given only once a month as part of a multi-drug regimen, a minimum of 2-week washout period is required prior to administration of CC-11050 Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he were to participate in the study. Any condition that confounds the ability to interpret data from the study (ie, HIV, chronic HepB, chronic HepC or TB patients under active treatment). Resolved TB patients will not be excluded from the study. Stable and well managed patients with Diabetes and hypertension will not be excluded from the study. Use of systemic corticosteroid or immunosuppressant therapy within 7 days of study medication initiation Pregnant or nursing females.
