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CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum

NCT03807362 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-07-07

No results posted yet for this study

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

DRUG

CC-11050

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

Sponsors & Collaborators

  • The Leprosy Mission Nepal

    lead OTHER

Principal Investigators

  • Mahesh Shah, MD · The Leprosy Mission Nepal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-07
Primary Completion
2021-03-30
Completion
2024-12-31

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03807362 on ClinicalTrials.gov