Generalized Pustular PsoriasisPhase 4NCT06013969
A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
A Phase 4 study testing Spesolimab in people with Generalized Pustular Psoriasis, run by LEO Pharma at 35 sites in 17 countries.
Trial summary
This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Pustular Psoriasis
- What is being tested?
- Spesolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 35 sitesin 17 countries
- Study dates
- 22 Oct 2023to 2 Sep 2026
- 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
- Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 or 1 and a known and documented history of Generalized Pustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network - ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) gene mutation status or Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN gene mutation status.
- Patients must have a history of frequent GPP flares in the past
- Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening
- Signed and dated written informed consent prior to admission to the trial in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to start of any screening procedures
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
Who cannot join
- Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)
- Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques
- Patients with primary erythrodermic psoriasis vulgaris
- Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome
- Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or acute renal failure
- Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold upper limit normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin
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- Presence of acute demyelinating neuropathy
- Treatment with any drug considered likely to interfere with the safe conduct of the trial, as assessed by the investigator
- Further exclusion criteria apply.
Trial locations and contacts
35 sites in 17 countries.
35 sites in 17 countries
Malaysia7 sites
Hospital Selayang
Batu Caves, 68100
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, 10990
Hospital Sultanah Aminah
Johor Bahru, 80100
Hospital Sultan Ismail
Johor Bahru, 81100
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Hospital Putrajaya
Putrajaya, 62250
Sunway Medical Centre
Selangor Darul Ehsan, 47500
China3 sites
Southern Medical University Dermatology Hospital
Guangzhou, 510091
Shanghai Skin Disease Hospital
Shanghai, 200000
Shanghai Tenth People's Hospital
Shanghai, 200072
United States2 sites
Red River Research Partners, LLC
Fargo, North Dakota, 58103
University of California Irvine
Irvine, California, 92697
Australia2 sites
Liverpool Hospital
Liverpool, New South Wales, 2170
Westmead Hospital
Westmead, New South Wales, 2145
Brazil2 sites
Hospital Universitario Evangelico Mackenzie
Curitiba, 80440-220
Faculdade de Medicina do ABC
Santo André, 09060-870
France2 sites
HOP Trousseau
Chambray-lès-Tours, 37170
HOP Saint-Louis
Paris, 75010
Germany2 sites
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596
Klinikum der Universität München AÖR
München, 80337
India2 sites
SP medical college and associated group of hospitals
Bikaner, 334003
Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur, 440019
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Taiwan2 sites
National Taiwan University Hospital
Taipei, 100
Chang Gung Memorial Hospital, Linkou
Taoyuan, 330
Thailand2 sites
Srinagarind Hospital
Khon Kaen, 40000
Maharat Nakhonchiangmai Hospital
Muang Chiang Mai, 50200
Tunisia2 sites
Hedi Chaker Hospital, Department of Dermatology
Sfax, 1053
Farhat Hached Hospital
Sousse, 4000
Singapore1 site
National University Hospital-Singapore-42005
Singapore, 119228
South Africa1 site
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Mthatha, Eastern Cape, 5099
About this study
Official title: Effisayil® REP: An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.
This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP.
Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares.
During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.
- Conditions
- Generalized Pustular Psoriasis
- Being tested
- Spesolimab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpesolimabDrug
Also called Spevigo®
Spesolimab intravenous (i.v.) infusion
| Study group | Role | What they receive |
|---|---|---|
| GPP Patients | Experimental | Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab. Receives: Drug: Spesolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1
Measured: Up to week 1
Secondary outcomes (1)
Achievement of a GPPGA pustulation sub-score of 0 or 1, with a ≥2-point reduction from baseline at Week 1
Measured: Up to week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start22 Oct 2023
- Primary completion13 May 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular PsoriasisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013969
- Sponsor's protocol ID
- 1368-0120
- Other IDs
- 2022-502128-38-00, U1111-1291-3088
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effisayil® REP: An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.
- ClinicalTrials.gov ID
- NCT06013969
- Acronym / sponsor ID
- 1368-0120
- Conditions
- Generalized Pustular Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- 22 Oct 2023 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 28 Aug 2023 (actual)
- 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.
This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP.
Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares.
During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPP Patients | Experimental | Drug: SpesolimabGeneralized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 or 1 and a known and documented history of Generalized Pustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network - ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) gene mutation status or Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN gene mutation status.
- Patients must have a history of frequent GPP flares in the past
- Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening
- Signed and dated written informed consent prior to admission to the trial in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to start of any screening procedures
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
Key exclusion criteria (9 listed)
- Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)
- Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques
- Patients with primary erythrodermic psoriasis vulgaris
- Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome
- Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or acute renal failure
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 |
|---|---|---|
| SpesolimabAlso: Spevigo®Spesolimab intravenous (i.v.) infusion | Drug | GPP Patients |
Primary outcome
Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1
Time frame: Up to week 1
1 secondary outcome
Achievement of a GPPGA pustulation sub-score of 0 or 1, with a ≥2-point reduction from baseline at Week 1
Time frame: Up to week 1
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 26 Oct 2026.
- 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.
Medical Expert study director
LEO Pharma
35 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spesolimab in people with Generalized Pustular Psoriasis, run by LEO Pharma at 35 sites in 17 countries.
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 5 inclusion and 9 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Malaysia, China, United States, Australia, Brazil and 12 more countries. 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. 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?
Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1 (time frame: Up to week 1). 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 26 Oct 2026.