Spesolimab in Pyoderma Gangrenosum | NCT06092216

NCT06092216

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Boehringer Ingelheim	INDUSTRY

Description Module

Label	Type	Description	Intervention Names
Spesolimab	Experimental	900 mg of spesolimab intravenously (IV)	Drug: Spesolimab

Name	Type	Description	Arm Group Labels	Other Names
Spesolimab	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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. 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; 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. 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 Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present.	Baseline and Week 16

Secondary Outcomes

Measure	Description	Time Frame
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	Up to Week 28

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects ≥ 18 years of age at the time of signing the informed consent document
Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures
Subject is able to adhere to the study visit schedule and other protocol requirements.
Subject has clinically diagnosed ulcerative PG with PARACELSUS score greater than or equal to 10
Subject has at least one clinically measurable ulcerative PG lesion on body that has failed to respond to at least one prior therapy such as (but not limited to) topical corticosteroids, intralesional triamcinolone, prednisone, cyclosporine, IL-23 inhibitor, IL-17 inhibitors, IL-1 inhibitors, or TNF-α- blocker therapy
Subject has moderate to severe PG as determined by a GPG severity score of ≥3
Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, limited physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational 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 contraceptive options described below:
- Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.
- 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:
  - (a) diaphragm with spermicide
  - (b) cervical cap with spermicide;
  - or (c) contraceptive sponge with spermicide.

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:

Subject has a persistent or recurring bacterial infection requiring systemic antibiotics, or clinically significant viral or fungal or helminth parasitic infections, within 2 weeks of the Screening Visit. Any treatment of such infections must have been completed at least 2 weeks prior to the Screening Visit and no new/recurrent infections should have occurred prior to the Baseline Visit.
Subject with current or history of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (i.e. Common Variable Immunodeficiency [CVID]), hepatitis B or C, or active or untreated latent tuberculosis.
Subject has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases that will affect the health of the subject during the study, or interfere with the interpretation of study results. Uncontrolled disease defined as hospitalization within 1 month of screening visit or determined by specialist (rheumatologist, gastroenterologist) consulted prior to study start.
Subject has presence of acute demyelinating neuropathy
Major surgery (according to the investigator's assessment) performed within 12 weeks prior to receiving first dose of spesolimab or planned during trial such as hip replacement, aneurysm removal, stomach ligation, or otherwise determined by investigator
Subject has a suspected or active lymphoproliferative disorder or malignancy
Subject was treated previously with spesolimab or another IL-36R inhibitor biologic
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treatment basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Subject has received a live attenuated vaccine ≤ 30 days prior to study initiation.
History of adverse systemic or allergic reactions to any component of the study drug.
Female subject who is pregnant or breast feeding

Name	Affiliation	Role
Saakshi Khattri, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

ID	Title	Description
FG000	Spesolimab	900 mg of spesolimab intravenously (IV) 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.

ID	Title	Description
BG000	Spesolimab	900 mg of spesolimab intravenously (IV) 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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;
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.
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
Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present.

Includes all participants who did not withdraw

Posted

Mean

Standard Deviation

score on a scale

Baseline and Week 16

ID

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Spesolimab	900 mg of spesolimab intravenously (IV) 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 27, 2024	Jan 14, 2026	Prot_SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Aug 6, 2024	Sep 5, 2025	ICF_000.pdf

ID	Term
D011711	Pyoderma
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017445	Skin Diseases, Vascular