A Phase 2 interventional study of Spesolimab and Spesolimab in Generalized Pustular Psoriasis, sponsored by LEO Pharma. Active, not recruiting at 58 sites in 21 countries. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by LEO Pharma · Phase 2, Interventional, and Treatment
Among 10 studies testing spesolimab in Psoriasis — none open to participants now, 1 under way, none of them phase 3. spesolimab · Psoriasis.
Among the 10 studies testing spesolimab in Psoriasis, this one is the 2nd largest by enrollment, is one of 3 that started in 2019, is one of 6 in phase 2, and was the 4th registered.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 131 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →None of the 10 studies testing spesolimab in Psoriasis is open now.
spesolimab: first FDA approval 2022 (SPEVIGO), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 12 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 3 started in 2019.
Median enrollment 56 across the 10 interventional studies. Of the 9 that completed or were terminated, 8 (89%) have results posted.
10 of 10 have an industry lead sponsor. The 2 most frequent:
LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 24 (75%) have results posted.
79 studies in Psoriasis by LEO Pharma: 1 open now, 2 under way, none of them phase 3. Of 77 finished, 36 (47%) have results posted.
Among the 79 studies in Psoriasis by LEO Pharma, this one is the 29th largest by enrollment of the 71 interventional ones that give a count, is one of 3 that started in 2019, is one of 24 in phase 2, and was the 72nd registered.
LEO Pharma’s Psoriasis studies by the year they started, since 2004.
1 of the studies testing spesolimab in Psoriasis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03886246LEO PharmaEffisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study | 2027-09-30 |
Among the 10 studies testing spesolimab in Psoriasis, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among LEO Pharma’s 79 in Psoriasis:
This study is open to people with generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027).
The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolimab. The study also tests whether spesolimab helps improve GPP symptoms and how quickly the symptoms improve after a flare-up.
Every participant gets spesolimab for almost 5 years (252 weeks). Depending on their symptoms and whether they had a GPP flare during the previous trial, they get spesolimab every few weeks. When participants have a GPP flare during this trial, they get spesolimab as an infusion into a vein.
Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. To assess the study endpoints, doctors regularly check participants' skin.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Active or Latent tuberculosis (TB):
Further exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Spesolimab
Drug: Spesolimab
Drug: Spesolimab
Solution for infusion
Solution for injection
Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment
Time frame: Up to 252 Weeks
The reoccurrence of a GPP flare defined by GPPGA
The total GPPGA score ranges from 0 to 4 with a higher score indicating a higher grade of inflammation.
Time frame: Up to 252 Weeks
Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment)
Time frame: Up to 252 Weeks
A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit
Time frame: Up to 252 Weeks
Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit
The PSS score ranges from None to Very Severe with a higher score indicating a higher severity of psoriasis symptom.
Time frame: Up to 252 Weeks
Plan to share: No
No publications or documents are linked to this record.
Started May 2019 (actual). Primary completion is estimated for Sep 2027, 100 months after the start.
Of 145 industry-sponsored phase 2 interventional studies under Psoriasis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 20. This study's planned 100 months is above that.
Counting every sponsor, half of 174 studies reached it within 14 months; a quarter within 9 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Spesolimab