Status:
UNKNOWN
CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum
Lead Sponsor:
The Leprosy Mission Nepal
Conditions:
Erythema Nodosum Leprosum
Leprosy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03807362
Start Date
January 7 2018
End Date
December 31 2024
Last Update
July 7 2020
Active Locations (2)
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1
The Leprosy Mission Nepal
Kathmandu, Bagmati, Nepal, 44700
2
Anandaban Hospital
Lalitpur, Bagmati, Nepal, 44700