Spesolimab for Pyoderma Gangrenosum

Recruiting at 114 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: Corticosteroids

Must not be taking: Systemic antibiotics

Disqualifiers: Non-PG lesions, Active infections, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether spesolimab can heal skin ulcers in individuals with pyoderma gangrenosum (PG), a painful skin condition. Participants will receive either spesolimab or a placebo (a substance with no active drug) to determine if spesolimab aids in closing these ulcers. The trial targets adults with at least one PG ulcer measuring between 5 and 80 square centimeters. Participants will receive regular infusions and undergo monitoring for about 1.5 years to evaluate the treatment's effectiveness and any side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment.

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 there any evidence suggesting that spesolimab is likely to be safe for humans?

Research shows that spesolimab is generally safe, with most participants in earlier studies not experiencing serious side effects. It has already received approval for treating generalized pustular psoriasis (GPP), indicating its safety for that condition. In this study, researchers are testing it for another condition called pyoderma gangrenosum (PG). Its safety for GPP provides some confidence regarding its safety for PG. However, individual responses can vary, so regular health check-ups are important during the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pyoderma gangrenosum?

Spesolimab is unique because it targets the interleukin-36 (IL-36) pathway, which is different from how most current treatments for Pyoderma Gangrenosum work. Existing treatments typically involve immunosuppressants or systemic corticosteroids, which broadly suppress the immune system. In contrast, Spesolimab specifically blocks the IL-36 receptor, potentially offering a more targeted approach with fewer side effects. Researchers are excited about this treatment because it could provide faster and more effective relief by directly addressing the underlying inflammation process specific to this condition.

What evidence suggests that spesolimab might be an effective treatment for pyoderma gangrenosum?

Research suggests that spesolimab, which participants in this trial may receive, might help treat pyoderma gangrenosum (PG), a painful skin condition that causes large sores. In one case, a patient with PG improved after receiving spesolimab. This medication blocks the IL-36 receptor, which plays a role in inflammation. By doing so, it helps reduce inflammation and may help sores heal faster. Although more research is needed, early signs indicate that spesolimab could be a promising option for people with PG. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 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.

My target ulcer was diagnosed within the last 6 months or is active and worsening.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Spesolimab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Spesolimab Experimental Treatment 3 Interventions

Group II: Placebo Placebo Group 3 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

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

In a case study of a 27-year-old woman with severe Crohn's disease and refractory Pyoderma gangrenosum (PG), the combination of certolizumab pegol with systemic steroids and tacrolimus led to complete healing of PG after previous treatments failed.

Certolizumab pegol may serve as an effective alternative therapy for PG in patients who cannot tolerate or do not respond to other anti-TNF therapies, highlighting its potential role in managing this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab pegol - A new therapeutic option for refractory disseminated pyoderma gangrenosum associated with Crohn's disease. Hurabielle, C., Schneider, P., Baudry, C., et al.[2018]

New diagnostic criteria for pyoderma gangrenosum have been proposed to help speed up diagnosis and treatment, which is crucial to reduce complications and improve patient outcomes.

For treatment, local immunosuppressive therapies are recommended for mild cases, while severe cases may require systemic glucocorticoids, ciclosporin, or TNF-alpha inhibitors, with other biologics also being explored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pyoderma gangrenosum]. Burian, EA., Karlsmark, T., Fogh, K., et al.[2021]

Spesolimab, an interleukin-36 receptor antagonist, was approved in September 2022 in the USA specifically for treating flares of generalized pustular psoriasis (GPP) in adults.

The approval of spesolimab marks a significant milestone in the development of treatments for immune-mediated disorders, highlighting its potential efficacy in managing GPP flares.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spesolimab: First Approval. Blair, HA.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peristomal Pyoderma Gangrenosum Responding to Risankizumab. Weigelt, MA., Kirsner, RS.[2023]

A 46-year-old patient with severe pyoderma gangrenosum related to Crohn's disease showed significant improvement after receiving infliximab, a medication that targets tumor necrosis factor-alpha, administered intravenously at 5 mg/kg.

The patient's abdominal symptoms and skin lesions improved markedly after the first dose, and they have remained in remission on a maintenance regimen, suggesting that infliximab is an effective treatment for both Crohn's disease and associated skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Favorable response to infliximab treatment in a patient with active Crohn disease and pyoderma gangrenosum. Triantafillidis, JK., Cheracakis, P., Sklavaina, M., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on adalimumab for pyoderma gangrenosum. Yamamoto, T.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologics and immunoglobulins in the treatment of pyoderma gangrenosum - analysis of 52 patients. Herberger, K., Dissemond, J., Brüggestrat, S., et al.[2019]

Tofacitinib, an immunosuppressive agent, showed promising results in treating pyoderma gangrenosum (PG) in a small group of 10 patients who had previously failed an average of four other treatments.

In this study, 40% of patients experienced complete healing of their ulcers, while 60% showed significant clinical improvement, suggesting that tofacitinib could be an effective steroid-sparing option for refractory PG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tofacitinib for the treatment of refractory pyoderma gangrenosum. Orfaly, VE., Kovalenko, I., Tolkachjov, SN., et al.[2021]

Glucocorticoids are the first-line treatment for pyoderma gangrenosum (PG), but recent evidence suggests that biologics, such as TNF-α inhibitors and IL-1 inhibitors, are emerging as effective alternatives.

The article reviews various treatment options for PG, including local therapies and systemic medications, aiming to guide clinicians in managing this rare and complex skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current situation and the latest progress in the treatment of pyoderma gangrenosum]. Li, Y., Wang, YY., Xing, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06624670

NCT06624670 | A Study to Test Whether Spesolimab ... 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 ...

2. jaad.org jaad.org/article/S0190-9622(25)01851-1/fulltext

59674 Randomized Phase 3 trial of spesolimab in patients ... Conclusions: These results will provide safety and efficacy data on spesolimab as a potential treatment for ulcerative PG. Article metrics. Related Articles.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12009905/

Case Report: Spesolimab for pyoderma gangrenosum in an ... The case highlights the successful use of Spesolimab (anti-IL36R) in treating PG and explores the potential “paradoxical phenomenon” linked to anti-IL-17 ...

4. clinicaltrial.be clinicaltrial.be/en/details/453227?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Study to Test Whether Spesolimab Helps People With a ... Primary outcomes 1. Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of ...

5. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT06624670

Test Whether Spesolimab Helps People With a Skin ... The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG).

6. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/clinical-pipeline/spesolimab-bi-655130-il36r-antibody-1

Spesolimab (BI 655130): IL36R antibody Indication: Pyoderma gangrenosum. Spesolimab is a first-in class anti-IL-36 receptor antibody from Boehringer Ingelheim´s own research. It is being investigated ...

7. sigma.larvol.com sigma.larvol.com/product.php?e1=572253&tab=newstrac

Spevigo (spesolimab-sbzo) News Spesolimab demonstrates a low prevalence of adverse events and clinical efficacy for GPP treatment including patients with comorbidities, infections, and over ...