CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-07

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Novel Interventions and Diagnostic Tests for Leprosy

NCT06222372

Leprosy

RECRUITING NA

Molecular Epidemiology of Leprosy - Philippines

NCT00315809

Leprosy

COMPLETED

Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus

NCT01593761

Skin Infection

COMPLETED PHASE2

A Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka

NCT04884958

Staphylococcus Aureus

UNKNOWN

Molecular and Immunological Tools for Detection of Strain Diversity, Drug Resistance and Immunological Responses

NCT00138437

Leprosy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erythema Nodosum Leprosum Leprosy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single center, open label pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CC-11050 treatment

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).

Group Type EXPERIMENTAL

CC-11050

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CC-11050

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Study participants must satisfy the following criteria to be enrolled in the study:

1. Must be 18 -65 years old, weight \> 35kg for women and \>40kg for men at the time of signing the informed consent.
2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
3. 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.
4. 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:

1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
2. 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
3. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he were to participate in the study.
4. 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.
5. Stable and well managed patients with Diabetes and hypertension will not be excluded from the study.
6. Use of systemic corticosteroid or immunosuppressant therapy within 7 days of study medication initiation
7. Pregnant or nursing females.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No