NCT04254627 (E/M) is a Phase 1 clinical trial of Etanercept in Gulf War Illness, sponsored by Nova Southeastern University.

Who is sponsoring NCT04254627?

NCT04254627 is sponsored by Nova Southeastern University.

What drugs are being tested in NCT04254627?

Interventions in NCT04254627: Etanercept, Mifepristone.

What condition does NCT04254627 study?

NCT04254627 studies Gulf War Illness.

Is NCT04254627 still recruiting?

NCT04254627 is currently active, enrolled. Last updated 17 February 2025.

Last reviewed 2025-02-17 · How we verify

NCT04254627: E/M

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

Tumor Necrosis Factor (TNF) and Glucocorticoid Antagonist for Gulf War Illness (GWI)-Associated Multi-symptom Disease Homeostasis Reset

Active, enrolled Phase 1 Last updated 17 February 2025

What this trial tests

Phase 1 trial testing Etanercept in Gulf War Illness in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 September 2021

Primary endpoint
1 September 2025

1 September 2025

Quick facts

Lead sponsor	Nova Southeastern University
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	24 September 2021
Primary completion	1 September 2025
Estimated completion	1 September 2025
Sites	2 locations across United States

Drugs / interventions tested

Etanercept (etanercept) — full drug profile →
Mifepristone (MIFEPRISTONE) — full drug profile →

Conditions studied

Gulf War Illness — all drugs for Gulf War Illness →

Sponsor

Nova Southeastern University

Who can join

Adults 45 to 70, male only, with Gulf War Illness. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety - incidence and severity of adverse events
Time frame: 16 weeks
Safety is assessed by the incidence and severity of adverse events, by relation to the study intervention.
Mechanistic effects on biomarker relationships
Time frame: Baseline and 24 weeks
Mechanistic effects on biomarker network dynamics are measured by the change in median summary score for network-level distance between the Gulf War Illness biomarker profile at rest and model-predicted stable (healthy) states. These summary scores have a minimum value of zero and reflect the overall difference between the multidimensional relationships of the immune, autonomic, and neuroendocrine

Sponsor's own description

Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal/joint pain. This phase I single-site, open-label two-arm study will assess the safety and mechanistic efficacy of a sequential etanercept-mifepristone intervention for Gulf War Illness. The results of this phase I study will be compared to those from an existing short-duration study to identify the optimal duration and dosage for use in a future phase II study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Gulf War Illness: Mechanisms Underlying Brain Dysfunction and Promising Therapeutic Strategies.
Dickey B, Madhu LN, Shetty AK. · · 2021 · cited 54× · PMID 33164782 · DOI 10.1016/j.pharmthera.2020.107716
Computational modeling-directed combination treatment with etanercept and mifepristone mitigates neuroinflammation in a mouse model of Gulf War Illness.
Kelly KA, Felton CM, Billig BK, Yilmaz AA, et al · · 2026 · PMID 41843558 · DOI 10.1371/journal.pone.0324577

Verify or expand the search:

Other trials of Etanercept

Trials testing the same drug.

NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis · not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT06707194 — Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis · Phase 4 · recruiting
NCT06011889 — Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome · Phase 2, PHASE3 · recruiting
NCT05281614 — Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D · EARLY_PHASE1 · completed

Other recruiting trials for Gulf War Illness

Currently open trials in the same condition.

NCT05820893 — Resistant Potato Starch to Alleviate GWI · Phase 2 · recruiting
NCT05367245 — Ca-Mg Butyrate in GWI · Phase 2 · recruiting
NCT05972291 — Mechanisms of Gulf War Illness · NA · recruiting
NCT05375812 — NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH) · recruiting
NCT05675878 — Confirmation of Diet as a Treatment for Gulf War Illness · Phase 3 · recruiting

Other Nova Southeastern University trials

Trials by the same sponsor.

NCT07298486 — Impact of Robotic Glove Use on Quality of Life, Grip Strength and Fine Motor Control in ALS · NA · enrolling by invitation
NCT07187388 — Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neu · NA · recruiting
NCT07280208 — Teach-Back Discharge Education to Improve Self-Care and Reduce 30-Day Readmissions in Heart Failure Patients · NA · completed
NCT06390137 — Anti-Inflammatory Effects Of Frequency Specific Microcurrent (FSM) In Osteoarthritic Adults · NA · completed
NCT06669442 — The Effectiveness of Guided Imagery on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder · NA · 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 NCT04254627 (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 Nova Southeastern University
Last refreshed: 17 February 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/NCT04254627.

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