NCT02739295: NeupoNET

Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis

Completed Phase 4 Last updated 26 December 2025

What this trial tests

Phase 4 trial testing recombinant granulocyte - colony stimulating factor in Stevens - Johnson Syndrome in 10 participants. Completed in 7 March 2023.

Timeline

1 July 2016

Primary endpoint
7 March 2023

7 March 2023

Quick facts

Lead sponsor	University of Liege
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	10
Start date	1 July 2016
Primary completion	7 March 2023
Estimated completion	7 March 2023
Sites	2 locations across Belgium

Drugs / interventions tested

• recombinant granulocyte - colony stimulating factor
• NaCl 0.9%

Conditions studied

• Stevens - Johnson Syndrome — all drugs for Stevens - Johnson Syndrome →

Sponsor

University of Liege

Who can join

18 and older, any sex, with Stevens - Johnson Syndrome. 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.

• Time for healing
  Time frame: From date of randomization until the date of complete healing, assessed up to 30 days.
  Time for complete cutaneous healing, considered as healing of 90% of the body surface area
• Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
  Time frame: At admission and at day 5
  Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
• Biological data: Neutrophilic count
  Time frame: Every day during the 14th first days
  Neutrophilic count

Sponsor's own description

NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial.

Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.

Publications & conference data

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

1. Systemic interventions for treatment of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS/TEN overlap syndrome.
   Jacobsen A, Olabi B, Langley A, Beecker J, et al · · 2022 · cited 56× · PMID 35274741 · DOI 10.1002/14651858.cd013130.pub2
2. Scoring Assessments in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
   Dobry AS, Himed S, Waters M, Kaffenberger BH. · · 2022 · cited 18× · PMID 35783656 · DOI 10.3389/fmed.2022.883121