Spesolimab clinical trials
Spesolimab is named as an intervention in 2 current clinical trials in our USA, China, Germany, France, Spain, Italy, Belgium, Japan, Taiwan, Sweden, Poland, Switzerland, Austria, Norway, Portugal, Canada, Brazil, Australia, Turkey, Mexico, South Korea and Singapore registers. 1 is recruiting patients now. The most common phase is Phase 3. The lead sponsor is LEO Pharma. The most-studied condition is Pyoderma Gangrenosum.
Where Spesolimab is approved
All regulators →Of the three regulators tracked here, the first to approve Spesolimab was the US, on 1 Sep 2022. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Spesolimab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Spesolimab works
All drug targets →- IL36 receptor antagonist AntagonistTarget: IL36 receptor✓ In ChEMBL and the Guide to Pharmacology
- Generalized pustular psoriasisPhase 3
- Pyoderma gangrenosumPhase 3
- Netherton syndromePhase 2/3
- Hidradenitis suppurativaPhase 2/3
- Ulcerative colitisPhase 2/3
- Crohn diseasePhase 2
- PyodermaPhase 2
- Atopic eczemaPhase 2
- Intestinal obstructionPhase 2
- Palmoplantar pustulosisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297911, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12169, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Spesolimab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Spesolimab. 2 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Subcutaneous spesolimab 1-ml formulation for preventing generalised pustular psoriasis flares in people 12 years and over (terminated appraisal) NICE TA1144 | Terminated (no company submission) | 8 Apr 2026 | Current |
| Spesolimab for treating generalised pustular psoriasis flares NICE TA1070 | Optimised | 18 Jun 2025 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Spesolimab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: SpevigoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Spesolimab
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
NCT06624670 · Pyoderma Gangrenosum
|
Phase 3 | Recruiting | LEO Pharma | USA, China, Germany, France, Spain, Italy, Belgium, Sweden, Poland, Switzerland, Austria, Norway, Portugal, Canada, Brazil, Japan, Taiwan, Australia |
|
Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
NCT03886246 · Generalized Pustular Psoriasis
|
Phase 2 | Active, closed | LEO Pharma | USA, China, Germany, France, Spain, Italy, Belgium, Turkey, Mexico, Japan, South Korea, Taiwan, Singapore |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Spesolimab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Spesolimab on the HPRA medicines list.
- Spevigo 150 mg solution for injection in pre-filled syringeLEO Pharma A/S · EU/1/22/1688/002
- Spevigo 300 mg solution for injection in pre-filled syringeLEO Pharma A/S · EU/1/22/1688/003
- Spevigo 450 mg concentrate for solution for infusionLEO Pharma A/S · EU/1/22/1688/001
Supply shortages
No entry for Spesolimab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Spesolimab
2 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| LEO Pharma | 2 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Spesolimab trials
How many clinical trials are testing Spesolimab?
2 current trials in our USA, China, Germany, France, Spain, Italy, Belgium, Japan, Taiwan, Sweden, Poland, Switzerland, Austria, Norway, Portugal, Canada, Brazil, Australia, Turkey, Mexico, South Korea and Singapore registers name Spesolimab as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Spesolimab trials recruiting patients?
Yes. 1 of the 2 trials is recruiting: 1 with sites in USA, 1 with sites in China, 1 with sites in Germany, 1 with sites in France, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Belgium, 1 with sites in Japan, 1 with sites in Taiwan, 1 with sites in Sweden, 1 with sites in Poland, 1 with sites in Switzerland, 1 with sites in Austria, 1 with sites in Norway, 1 with sites in Portugal, 1 with sites in Canada, 1 with sites in Brazil and 1 with sites in Australia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Spesolimab clinical trials?
The lead sponsor is LEO Pharma. The number in brackets is how many trials each organisation leads.
Is Spesolimab licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Spesolimab, for example Spevigo 150 mg solution for injection in pre-filled syringe (LEO Pharma A/S). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Spesolimab shortage?
Not in the lists we track: Spesolimab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Spesolimab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Spesolimab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Spesolimab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.