90 Participants Needed

Spesolimab for Pyoderma Gangrenosum

Recruiting at 91 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Boehringer Ingelheim
Must be taking: Corticosteroids
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since participants will be taking corticosteroids and possibly other treatments, it's best to discuss your current medications with the trial doctors to ensure there are no interactions.

Is spesolimab safe for human use?

Spesolimab has been approved in the USA for treating generalized pustular psoriasis flares in adults, indicating it has undergone safety evaluations for this condition.12345

How is the drug Spesolimab different from other treatments for pyoderma gangrenosum?

Spesolimab is unique because it targets the interleukin-36 receptor, which is different from other treatments that often target tumor necrosis factor (TNF) or interleukin-23. This novel mechanism may offer an alternative for patients who do not respond to or cannot tolerate existing therapies.16789

Eligibility Criteria

Adults diagnosed with ulcerative pyoderma gangrenosum (PG) who need systemic therapy can join this trial. They must have a PG ulcer between 5 cm² and 80 cm² that's been active for less than 6 months or still progressing if older. Women must use effective birth control.

Inclusion Criteria

I am 18 years old or older.
I have signed and understand the consent form for this trial.
I have a severe type of skin ulcer (PG) confirmed by a special score and need systemic treatment.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive spesolimab or placebo infusions every 4 weeks, with additional corticosteroid treatment for the first 8 weeks

28 weeks
7 visits (in-person)

Treatment Part 2

Participants continue to receive spesolimab or placebo infusions every 4 weeks, with allocation based on ulcer status

28 weeks
7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks
6 visits (in-person)

Treatment Details

Interventions

  • Spesolimab
Trial OverviewThe study tests if spesolimab helps heal ulcers caused by PG compared to placebo. Participants are randomly assigned to receive either spesolimab or placebo, alongside corticosteroids initially, over approximately 1.5 years with regular health checks.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpesolimabExperimental Treatment3 Interventions
Group II: PlaceboPlacebo Group3 Interventions

Spesolimab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Spevigo for:
  • Generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg
🇪🇺
Approved in European Union as Spevigo for:
  • Generalized pustular psoriasis (GPP) flares in adults

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

Findings from Research

Oral systemic treatments for pyoderma gangrenosum (PG), like cyclosporine and steroids, only achieve complete remission in about 50% of patients and can have significant side effects.
The case of a patient with peristomal PG showed a positive response to risankizumab, an anti-interleukin 23 monoclonal antibody, suggesting it could be a promising and safer treatment option that needs further research.
Peristomal Pyoderma Gangrenosum Responding to Risankizumab.Weigelt, MA., Kirsner, RS.[2023]
In a study of 52 patients with pyoderma gangrenosum, biologics, particularly TNFα antagonists like infliximab and adalimumab, showed a higher effectiveness with complete remission or improvement in 63.6% to 57.1% of cases, compared to only 48.8% for corticosteroids and 20% for cyclosporine A.
Biologics and intravenous immunoglobulins (IVIGs) were found to be well-tolerated, with lower rates of adverse events (18.5% for biologics and 20% for IVIGs) compared to 40% for cyclosporine A, suggesting they are safer alternatives for treating pyoderma gangrenosum.
Biologics and immunoglobulins in the treatment of pyoderma gangrenosum - analysis of 52 patients.Herberger, K., Dissemond, J., Brüggestrat, S., et al.[2019]
In a 26-week study involving 22 Japanese patients with pyoderma gangrenosum, adalimumab led to a significant reduction in ulcer size, with 54.5% of patients achieving complete skin re-epithelialization by week 26.
Adalimumab was generally well tolerated, although 18 patients experienced adverse events, primarily infections, indicating that while effective, monitoring for side effects is important.
An update on adalimumab for pyoderma gangrenosum.Yamamoto, T.[2021]

References

Peristomal Pyoderma Gangrenosum Responding to Risankizumab. [2023]
Biologics and immunoglobulins in the treatment of pyoderma gangrenosum - analysis of 52 patients. [2019]
An update on adalimumab for pyoderma gangrenosum. [2021]
Tofacitinib for the treatment of refractory pyoderma gangrenosum. [2021]
Spesolimab: First Approval. [2022]
Certolizumab pegol - A new therapeutic option for refractory disseminated pyoderma gangrenosum associated with Crohn's disease. [2018]
[Current situation and the latest progress in the treatment of pyoderma gangrenosum]. [2022]
[Pyoderma gangrenosum]. [2021]
Favorable response to infliximab treatment in a patient with active Crohn disease and pyoderma gangrenosum. [2015]