NCT03402087 is a Phase 1 clinical trial of Methotrexate in Lupus, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT03402087?

NCT03402087 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT03402087?

Interventions in NCT03402087: Methotrexate, Leucovorin, BMS-986165.

What condition does NCT03402087 study?

NCT03402087 studies Lupus, Psoriatic Arthritis.

Is NCT03402087 still recruiting?

NCT03402087 is currently completed. Last updated 25 February 2020.

Last reviewed 2020-02-25 · How we verify

NCT03402087

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

A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

Completed Phase 1 Last updated 25 February 2020

What this trial tests

Phase 1 trial testing Methotrexate in Lupus in 30 participants. Completed in 25 March 2018.

Timeline

8 January 2018

Primary endpoint
20 March 2018

25 March 2018

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	8 January 2018
Primary completion	20 March 2018
Estimated completion	25 March 2018
Sites	1 location across Netherlands

Drugs / interventions tested

Methotrexate — full drug profile →
Leucovorin (leucovorin) — full drug profile →
BMS-986165 — full drug profile →

Conditions studied

Lupus — all drugs for Lupus →
Psoriatic Arthritis — all drugs for Psoriatic Arthritis →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 50, male only, with Lupus or Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.

Publications & conference data

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

Deuterium in drug discovery: progress, opportunities and challenges.
Di Martino RMC, Maxwell BD, Pirali T. · · 2023 · cited 228× · PMID 37277503 · DOI 10.1038/s41573-023-00703-8

Verify or expand the search:

Other trials of Methotrexate

Trials testing the same drug.

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Other recruiting trials for Lupus

Currently open trials in the same condition.

NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
NCT07282392 — Helping Lupus Patients Manage Fibromyalgia Symptoms Through Emotional Awareness and Expression Therapy (EAET) · NA · recruiting
NCT06839976 — CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus · Phase 1, PHASE2 · recruiting
NCT06434363 — Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Di · Phase 1, PHASE2 · recruiting
NCT06013995 — A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With D · Phase 1 · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

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 NCT03402087 (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 Bristol-Myers Squibb
Last refreshed: 25 February 2020

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/NCT03402087.

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