CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum

NCT03807362 | Unknown Phase 2 DMC

• 1 other identifier: Nepal CC-11050
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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. 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with moderate to severe ENL with severity changes as assessed by the ENL Severity Scale.

  Changes in ENL Severity Scale Score (Walker et al., PLoS Negl Trop Dis 11(7): e0005716, https://doi.org/10.1371/journal.pntd.0005716) as compared to baseline and any previous time points. Ten clinical categories contribute 0-3 points toward the total score of 0-30. An ENL patient with a total scale score of less than 9 is considered to have mild ENL, while scores \>9 are considered moderate to severe ENL. A minimum score of 9 is required to indicate sufficient ENL symptoms from which post-intervention reduction in score(s) can be determined meaningful improvement.

  10 days, 28 days and monthly up to 1 year of treatment

Secondary Outcomes (8)

• Number of participants with moderate to severe ENL with decreased duration of episode(s) as assessed by standard ENL episode definition.

  10 days, 28 days, monthly up to 1 year of treatment and up to 1 year followup after treatment cessation.

• Number of participants with moderate to severe ENL with decreased bacterial index (BI) as assessed by slit skin smear microscopy.

  Enrolment and after 1 year treatment.

• Number of participants with moderate to severe ENL with decreased bacterial index (BI) as assessed skin histopathology.

  Enrolment and after 1 year treatment.

• Number of patients with moderate to severe ENL with improved peripheral neuropathy as assessed by standardized monofilament and voluntary muscle tests.

  enrolment, 10 days, 28 days, biweekly (as needed), up to 1 year treatment, up to 1 year followup after treatment cessation

• Number of participants with moderate to severe ENL with improved quality of life as assessed by the World Health Organization Quality of Life tool.

  Enrolment, 28 days, monthly up to 1 year of treatment and up to 1 year followup after treatment cessation.

Study Arms (1)

CC-11050 treatment

EXPERIMENTAL

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).

Drug: CC-11050

Interventions

CC-11050 DRUG

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

CC-11050 treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Males only for Step 1 (first 10 patients for testing up to 28 days of treatment). If successful, then both males and females can enroll in the second part of the study (up to 40 patients testing up to 1 year of therapy).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Leprosy Mission Nepal: lead

Study Sites (2)

The Leprosy Mission Nepal

Kathmandu, Bagmati, 44700, Nepal

NOT YET RECRUITING

Anandaban Hospital

Lalitpur, Bagmati, 44700, Nepal

RECRUITING

MeSH Terms

Conditions

Leprosy

Interventions

CC-11050

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mahesh Shah, MD

  The Leprosy Mission Nepal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahesh Shah, MD

CONTACT

+9779841203417; drmahesh_shah@yahoo.com

Indra B Napit, MD

CONTACT

indranapit@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single center, open label pilot study

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: January 16, 2019
• Study Start: January 7, 2018
• Primary Completion: March 30, 2021
• Study Completion: December 31, 2024
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

NE (2)