A Phase 2 interventional study of Spesolimab in Pyoderma Gangrenosum, sponsored by Icahn School of Medicine at Mount Sinai. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Treatment
The purpose of this research study is to assess the feasibility of using spesolimab in participants with moderate to severe pyoderma gangrenosum. Pyoderma gangrenosum is a rare, inflammatory, autoimmune condition which results in ulceration of skin. The study will also investigate the body's immune response to the spesolimab (when the body detects and defends itself against substances that appear unknown and harmful).
To date, there is no gold standard for treatment of PG. Patients with pyoderma gangrenosum suffer from severe pain and poor quality of life due to frequent dressing changes and disfiguring lesions. More importantly, rapidly progressing ulcers present an important risk for infection, morbidity, and mortality for patients. Spesolimab is humanized antagonistic monoclonal IgG1 antibody that blocks human IL36R signalling and subsequent downstream pro-inflammatory pathways. The IL-36 receptor blocker was recently approved for generalized pustular psoriasis (GPP). The research team hypothesize that targeting IL-36 in refractory, ulcerative postoperative PG may result in regression and resolution of a patient's lesions.
There are, at minimum, a total of 14 or 15 visits which will include physical exams, blood testing and infectious disease testing, completing questionnaires, and photographs and assessment of skin affected by PG. Spesolimab will be administered via a 90-minute infusion every 3 or 4 weeks (depending on response at Visit 4) at 8 or 9 Visits during the study.
36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.
This study's enrollment of 5 is below the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.
Browse Pyoderma Gangrenosum studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Females of (FCBP) must have a negative pregnancy test at Screening and Baseline. While on product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved options described below:
Or option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]). PLUS one additional barrier method:
The female subject's chosen form of contraception must be effective by the time the female subject presents for her Baseline visit (for example, hormonal contraception should be initiated at least 28 days before first spesolimab infusion at Baseline).
Exclusion Criteria:
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
900 mg of spesolimab intravenously (IV)
Drug: Spesolimab
900 mg of spesolimab intravenously (IV) administered every 4 weeks at Visits 2, 3, 4, 5, 6, 7, 8, 9. If at visit 4 dosing schedule changes to every 3 weeks, Spesolimab will be administered at Visits 2, 3, 4, 5, 6, 8, 9, 10 and 11.
Change in Global Pyoderma Gangrenosum (GPG) Severity Score
Change in GPG severity score at week 16 from baseline in target lesion 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent, lesion is dry. 1. Almost clear; \<25% of active ulceration present; \> 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation; 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon examination. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present.
Time frame: Baseline and Week 16
Number of Lesions With Complete Re-epithelization of PG Lesions
Number of lesions with Complete re-epithelization of PG lesions = GPG Score 0 GPG Score 0 - Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent and lesion is dry
Time frame: Up to Week 28
Absolute Change in Patient-reported Pain Severity (Pain-VAS) Score
Absolute change at Week 28 from baseline in patient-reported pain severity (Pain-VAS). Patient Pain Visual Analogue Scale (VAS): Patients will be asked to report pain scores at each visit. Patients will report scores on a scale of 0 to 10. 0 signifies no pain and 10 signifies the worst pain imaginable. Higher scores indicate increased levels of pain.
Time frame: Baseline and at Week 28
Absolute Change in Dermatology Life Quality Index (DLQI)
Absolute Change at week 28 from baseline in DLQI. The DLQI is a validated questionnaire consisting of 10 questions that has been used in many randomized controlled trials in dermatology. Scoring of each question is as follows: Very much - 3 A lot - 2 A little - 1 Not at all - 0 Not relevant - 0 Question unanswered - 0 The DLQI is calculated by summing the score of each question with total scale from 0-30. Higher score represents a quality of life that is more impaired. Definition of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life A change in DLQI score of at least 4 points is considered clinically important. Such change suggests that there has actually been a meaningful change in that patient's quality of life since the previous measurement of his/her/their DLQI scores.
Time frame: Baseline and at Week 28
Number of Recurrence of PG Lesions (GPG >0) After Achieving Complete Re-epithelialization (GPG Score 0) and Spesolimab Cessation
GPG Severity Score Scale: 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent, lesion is dry 1. Almost clear; \<25% of active ulceration present; \> 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon exam. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present. No evidence of granulation tissue. Extensive purulent drops on ulcer bed
Time frame: Last dose (Week 26 or 28) up to 16 week post-spesolimab last dose
Number of Lesions With Global Pyoderma Gangrenosum (GPG) Severity Score of 1
Lesions with GPG score of 1 Scale: 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent and lesion is dry 1. Almost clear; \<25% of active ulceration present; more than 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon examination. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present. No evidence of granulation tissue
Time frame: Last dose (Week 26 or 28) up to 16 week post-spesolimab last dose
| Milestone | Spesolimab |
|---|---|
| Started | 5 |
| Completed | 1 |
| Not completed | 4 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Withdrawal by subject | 2 |
Change in GPG severity score at week 16 from baseline in target lesion 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent, lesion is dry. 1. Almost clear; \<25% of active ulceration present; \> 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation; 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon examination. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present.
| score on a scale | Spesolimab |
|---|---|
| Change in Global Pyoderma Gangrenosum (GPG) Severity Score | -3 ± 2 |
Number of lesions with Complete re-epithelization of PG lesions = GPG Score 0 GPG Score 0 - Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent and lesion is dry
| lesions | Spesolimab |
|---|---|
| Number of Lesions With Complete Re-epithelization of PG Lesions | 3 |
Absolute change at Week 28 from baseline in patient-reported pain severity (Pain-VAS). Patient Pain Visual Analogue Scale (VAS): Patients will be asked to report pain scores at each visit. Patients will report scores on a scale of 0 to 10. 0 signifies no pain and 10 signifies the worst pain imaginable. Higher scores indicate increased levels of pain.
| absolute change of score on a scale | Spesolimab |
|---|---|
| Absolute Change in Patient-reported Pain Severity (Pain-VAS) Score | -5.33 ± 4.62 |
Absolute Change at week 28 from baseline in DLQI. The DLQI is a validated questionnaire consisting of 10 questions that has been used in many randomized controlled trials in dermatology. Scoring of each question is as follows: Very much - 3 A lot - 2 A little - 1 Not at all - 0 Not relevant - 0 Question unanswered - 0 The DLQI is calculated by summing the score of each question with total scale from 0-30. Higher score represents a quality of life that is more impaired. Definition of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life A change in DLQI score of at least 4 points is considered clinically important. Such change suggests that there has actually been a meaningful change in that patient's quality of life since the previous measurement of his/her/their DLQI scores.
| absolute change in score on a scale | Spesolimab |
|---|---|
| Absolute Change in Dermatology Life Quality Index (DLQI) | -7 ± 4.62 |
GPG Severity Score Scale: 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent, lesion is dry 1. Almost clear; \<25% of active ulceration present; \> 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon exam. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present. No evidence of granulation tissue. Extensive purulent drops on ulcer bed
| lesions | Spesolimab |
|---|---|
| Number of Recurrence of PG Lesions (GPG >0) After Achieving Complete Re-epithelialization (GPG Score 0) and Spesolimab Cessation | 2 |
Lesions with GPG score of 1 Scale: 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent and lesion is dry 1. Almost clear; \<25% of active ulceration present; more than 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon examination. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present. No evidence of granulation tissue
| lesions | Spesolimab |
|---|---|
| Number of Lesions With Global Pyoderma Gangrenosum (GPG) Severity Score of 1 | 2 |
Collected over Last dose (Week 26 or 28), up to 1 weeks post-spesolimab last dose. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spesolimab | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | Spesolimab |
|---|---|
| Worsening Pyoderma Gangrosum (PG)Skin and subcutaneous tissue disorders | 2/3 |
| Deep Vein Thrombosis (DVT)Blood and lymphatic system disorders | 1/3 |
| HyperlipidemiaGeneral disorders | 1/3 |
| Corneal AbrasionEye disorders | 1/3 |
| HypertensionGeneral disorders | 1/3 |
| Intermittent Leg SwellingBlood and lymphatic system disorders | 1/3 |
| Age, Continuous(years) | Spesolimab |
|---|---|
| Mean | 54 ± 12 |
| Sex: Female, Male(Participants) | Spesolimab |
|---|---|
| Female | 4 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Spesolimab |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Spesolimab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Data will be analyzed as aggregated data.
Ran from Sep 2023 to primary completion in Jan 2025, 15 months.
Results were first posted in Mar 2026, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spesolimab
Icahn School of Medicine at Mount Sinai →