Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Individuals who diagnosed with leprosy complicated by ENL
. Individuals with ENL aged 18-60 years old
. Individuals with ENL deteriorating symptoms
. Individuals with 10 or more tender, papular or nodular ENL skin lesions
. Individuals with an EESS score of at least 9
. Individuals with ENL on:
. No current anti- ENL treatment
. Prednisolone up to 30mg per day (if ACUTE) or Prednisolone 10-30mg (inclusive) per day (if RECURRENT/ CHRONIC) or equivalent alternative corticosteroid dose OR
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of individuals free from Erythema Nodosum Leprosum (ENL) flares in 24 weeks
Timeframe: During the first 24 weeks
2
Proportion of individuals free from ENL flares in 48 weeks
Timeframe: During first 48 weeks
Trial details
NCT IDNCT03775460
SponsorLondon School of Hygiene and Tropical Medicine
. Individuals who were first diagnosed with ENL more than 4 years prior to enrolment
. Individuals less than 18 years old or older than 60 years
. Individuals weighing less than 35kg
. Individuals with 9 or fewer tender, popular or nodular ENL skin lesions
. Individuals with an EESS score of 8 or less
. Women of child bearing capacity who decline to use two forms of adequate contraception and men who decline to use two forms of adequate contraception
. Pregnant or breastfeeding women
. Individuals with recurrent or chronic ENL who deteriorate on a dose of prednisolone less than 10 mg or more than 30 mg