Stevens - Johnson SyndromePhase 4NeupoNETNCT02739295
G-CSF in the Treatment of Toxic Epidermal Necrolysis
A Phase 4 study testing recombinant granulocyte - colony stimulating factor and NaCl 0.9% in people with Stevens - Johnson Syndrome, run by University of Liege at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stevens - Johnson Syndrome
- What is being tested?
- recombinant granulocyte - colony stimulating factor and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesBelgium
- Study dates
- Jul 2016to 7 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission
Who cannot join
- Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission
- Hypercoagulable state
- Cardiac or peripheral arterial disease
- Active malignancy
- Myelodysplastic syndrome or hematological malignancy
- Fructose intolerance
- Pregnancy
- Patient refusal
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Burn Centre of the University Hospital of Liège
Liège, 4000
IMTR Burn Centre
Loverval
About this study
Official title: Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
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.
- Conditions
- Stevens - Johnson Syndrome
- Being tested
- recombinant granulocyte - colony stimulating factor, NaCl 0.9%
- Medical subject headings
- Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant granulocyte - colony stimulating factorDrug
Also called Neupogen (Amgen)
NaCl 0.9%Drug
| Study group | Role | What they receive |
|---|---|---|
| G-CSF | Experimental | An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4. Receives: Drug: recombinant granulocyte - colony stimulating factor |
| Placebo | Placebo comparator | An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4. Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for healing
Time for complete cutaneous healing, considered as healing of 90% of the body surface area
Measured: From date of randomization until the date of complete healing, assessed up to 30 days.
Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Measured: At admission and at day 5
Biological data: Neutrophilic count
Neutrophilic count
Measured: Every day during the 14th first days
Secondary outcomes (2)
Biological data: WBC count
WBC count
Measured: 3 months after discharge
Biological data: WBC formula
WBC formula
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stevens - Johnson SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Françoise Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739295
- Sponsor's protocol ID
- L002
- Acronym
- NeupoNET
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2016
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
- ClinicalTrials.gov ID
- NCT02739295
- Acronym / sponsor ID
- NeupoNET / L002
- Conditions
- Stevens - Johnson Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF | Experimental | Drug: recombinant granulocyte - colony stimulating factorAn intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4. |
| Placebo | Placebo comparator | Drug: NaCl 0.9%An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission
Key exclusion criteria (8 listed)
- Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission
- Hypercoagulable state
- Cardiac or peripheral arterial disease
- Active malignancy
- Myelodysplastic syndrome or hematological malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant granulocyte - colony stimulating factorAlso: Neupogen (Amgen) | Drug | G-CSF |
| NaCl 0.9% | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Biological data: WBC count
Time frame: 3 months after discharge
Biological data: WBC formula
Time frame: 3 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant granulocyte - colony stimulating factor and NaCl 0.9% in people with Stevens - Johnson Syndrome, run by University of Liege at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for healing (time frame: From date of randomization until the date of complete healing, assessed up to 30 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.