NCT03775460 (MaPs) is a NA clinical trial of Methotrexate in Erythema Nodosum Leprosum, sponsored by London School of Hygiene and Tropical Medicine.

Who is sponsoring NCT03775460?

NCT03775460 is sponsored by London School of Hygiene and Tropical Medicine.

What drugs are being tested in NCT03775460?

Interventions in NCT03775460: Methotrexate, Placebo, Prednisolone.

What condition does NCT03775460 study?

NCT03775460 studies Erythema Nodosum Leprosum.

Is NCT03775460 still recruiting?

NCT03775460 is currently active, enrolled. Last updated 10 September 2025.

Last reviewed 2025-09-10 · How we verify

NCT03775460: MaPs

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

Active, enrolled NA Last updated 10 September 2025

What this trial tests

NA trial testing Methotrexate in Erythema Nodosum Leprosum in 550 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 January 2023

Primary endpoint
1 September 2025

1 October 2025

Quick facts

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	550
Start date	15 January 2023
Primary completion	1 September 2025
Estimated completion	1 October 2025
Sites	7 locations across Ethiopia, Indonesia, Nepal, Bangladesh, Brazil, India

Drugs / interventions tested

Methotrexate — full drug profile →
Placebo
Prednisolone — full drug profile →

Conditions studied

Erythema Nodosum Leprosum — all drugs for Erythema Nodosum Leprosum →

Sponsor

London School of Hygiene and Tropical Medicine

Who can join

Adults 18 to 60, any sex, with Erythema Nodosum Leprosum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Methotrexate and Prednisolone compared to placebo and prednisolone in the treatment of Erythema Nodosum Leprosum - an international multicentre, double-blind randomised controlled clinical trial - MaPs in ENL
de Barros B, Sultana F, Maximus N, Pai VV, et al · · 2026 · DOI 10.64898/2026.05.19.26353561

Verify or expand the search:

Other trials of Methotrexate

Trials testing the same drug.

NCT07498465 — A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant · Phase 1 · withdrawn
NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
NCT07321912 — Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma · Phase 2 · not yet recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07477691 — Immune Modulation During Palynziq® Treatment in Adults (IMPALA) · Phase 4 · not yet recruiting

Other London School of Hygiene and Tropical Medicine trials

Trials by the same sponsor.

NCT06921213 — Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis · Phase 2 · not yet recruiting
NCT06923592 — Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar · Phase 3 · recruiting
NCT06833736 — A Health App Using Recipes and Education Components to Facilitate Sustainable and Healthier Diets. · NA · completed
NCT06166498 — Parasite Clearance and Protection From Infection (PCPI) in Zambia · Phase 3 · completed
NCT06173206 — Parasite Clearance and Protection From Infection (PCPI) in Cameroon · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03775460 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine
Last refreshed: 10 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03775460.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing