Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: Systemic antibiotics
Disqualifiers: HIV, Hepatitis B/C, Tuberculosis, others
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing spesolimab, a medicine that blocks inflammation signals, in patients with severe skin ulcers caused by pyoderma gangrenosum. These patients often suffer from pain and have no standard treatment options. Spesolimab aims to reduce inflammation and help heal their skin ulcers.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is Spesolimab safe for human use?
Spesolimab, also known as spesolimab-sbzo or SPEVIGO, has been approved in the USA for treating generalized pustular psoriasis flares in adults, indicating it has undergone safety evaluations for this condition. While specific safety data for pyoderma gangrenosum is not available, its approval for another condition suggests it has been deemed generally safe for human use.
12345How 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.
16789Eligibility Criteria
Adults with moderate to severe pyoderma gangrenosum, a skin ulcer condition, who haven't responded to treatments like steroids or other immune therapies. Participants must be in good health otherwise and women of childbearing age must use effective contraception.Inclusion Criteria
My gum disease is moderate to severe, with a score over 3.
I am not pregnant, will use effective birth control, and have a negative pregnancy test.
Subject is able to adhere to the study visit schedule and other protocol requirements
+5 more
Exclusion Criteria
I haven't had serious infections or needed antibiotics in the last 2 weeks.
I have or had HIV, immunodeficiency, hepatitis B or C, or tuberculosis.
I do not have any major health issues that are not under control.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive spesolimab via a 90-minute infusion every 3 or 4 weeks, with a total of 8 or 9 visits during the study
16-28 weeks
8-9 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of PG lesion recurrence and quality of life
16 weeks
4-6 visits (in-person)
Participant Groups
The trial is testing spesolimab's effectiveness on pyoderma gangrenosum by observing changes in the body's immune response and improvement in skin ulcers.
1Treatment groups
Experimental Treatment
Group I: SpesolimabExperimental Treatment1 Intervention
900 mg of spesolimab intravenously (IV)
Spesolimab is already approved in United States, European Union for the following indications:
๐บ๐ธ 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
๐ช๐บ Approved in European Union as Spevigo for:
- Generalized pustular psoriasis (GPP) flares in adults
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
Boehringer IngelheimIndustry Sponsor
References
Peristomal Pyoderma Gangrenosum Responding to Risankizumab. [2023]Evidence to support available therapies for pyoderma gangrenosum (PG) is limited. Many patients do not respond to topical therapies such as tacrolimus or topical steroids. Currently favored oral systemic treatments (eg, cyclosporine and steroids) achieve complete remission in only 50% of patients and have unfavorable adverse effect profiles. There is a growing body of evidence to support biologic agents for the treatment of PG, but their exact role remains unclear. Here the authors present a patient with peristomal PG, the first reported case of PG responding to treatment with risankizumab, an anti-interleukin 23 monoclonal antibody. Risankizumab may represent an effective and relatively safe treatment for PG that merits additional exploration in prospective, controlled studies.
Biologics and immunoglobulins in the treatment of pyoderma gangrenosum - analysis of 52 patients. [2019]Corticosteroids and cyclosporine A are frequently ineffective as first-line therapies in the treatment of pyoderma gangrenosum (PG) and associated with a number of adverse effects. The objective of the present study was to analyze the effectiveness and safety of biologics and intravenous immunoglobulins (IVIGs).
An update on adalimumab for pyoderma gangrenosum. [2021]Pyoderma gangrenosum is a refractory disease characterized by chronic ulcers, presenting with central deep ulceration and undermined borders predominantly involving the lower extremities. Oral prednisolone and/or cyclosporine has been considered to be a first line of therapy; however, there are still unmet needs for treatment. Recently, effects of adalimumab for pyoderma gangrenosum in 22 Japanese patients were examined in an open-label, multicenter study during a 26-week treatment period and a further 26-week extension period. Pyoderma gangrenosum area reduction 100 (PGAR 100, defined as complete skin re-epithelialization) response for the target ulcer was observed in 3 patients (13.6%) as early as week 6, and at week 26, 12 patients (54.5%) achieved the primary endpoint of PGAR 100. The mean percent change from baseline in target ulcer area was -63.8% at week 26. A physician's global assessment score of 0 (PGA 0) was achieved by 8 patients (36.4%), while PGA 0/1 (completely/almost clear) was achieved by 12 patients (54.5%) at week 26. Adverse events were reported by 18 patients, most commonly infections (n = 11) and serious adverse events (n = 4). These results suggest that adalimumab is effective and generally well tolerated in Japanese patients with pyoderma gangrenosum active ulcers.
Tofacitinib for the treatment of refractory pyoderma gangrenosum. [2021]Pyoderma gangrenosum (PG) is a rare, debilitating, inflammatory skin disease associated with a variety of systemic diseases. Because of its rarity, PG is treated with miscellaneous immunosuppressive agents as there is no US Food and Drug Administration-approved standardized treatment approach. We present four patients with PG treated with tofacitinib in the context of the six existing cases in the literature. Tofacitinib appeared to be beneficial in the small sample of patients (n = 10) who failed an average of four other systemic therapies. The majority of patients had classic PG located on the legs (80%, 8/10), while 20% of cases (2/10) were peristomal. The most common comorbidity was inflammatory bowel disease (78%, 7/9). There were no negative treatment results and 40% (4/10) of patients had complete healing of their ulcers, while the other 60% (6/10) had marked clinical improvement. From our observation, tofacitinib appears to be a promising steroid-sparing adjuvant treatment in patients with refractory PG who have failed on other systemic therapies.
Spesolimab: First Approval. [2022]Spesolimab (spesolimab-sbzo; SPEVIGO®) is an interleukin (IL)-36 receptor antagonist being developed by Boehringer Ingelheim for the treatment of various immune-mediated disorders. In September 2022, spesolimab was approved in the USA for the treatment of generalized pustular psoriasis (GPP) flares in adults. This article summarizes the milestones in the development of spesolimab leading to this first approval for GPP flares.
Certolizumab pegol - A new therapeutic option for refractory disseminated pyoderma gangrenosum associated with Crohn's disease. [2018]Systemic steroids, in association or not with cyclosporin, are indicated for the treatment of large or widespread Pyoderma gangrenosum (PG). We report the case of a 27-year-old woman with a 15-year history of severe Crohn's disease, who developed a severe and disseminated PG, refractory to multiple lines of treatment. Infliximab and adalimumab were contraindicated, either because of allergy or of ineffectiveness on Crohn's disease. The addition of certolizumab pegol to the baseline treatment, associating systemic steroids and tacrolimus, finally allowed the complete healing of PG. Oral prednisone was stopped and tacrolimus was decreased, without any cutaneous or digestive relapse. Certolizumab pegol could be an alternative therapy in the treatment of PG in case of intolerance or ineffectiveness of the other anti-tumor necrosis factor (anti-TNF) therapies.
[Pyoderma gangrenosum]. [2021]Pyoderma gangrenosum is a diagnostic and therapeutic challenge. A misdiagnosis or delayed diagnosis can lead to increased morbidity and death. A fast workup and initiation of treatment is essential. In this review, we present new diagnostic criteria, which can ease the diagnosis, and we summarise the evidence of different treatment modalities. The evidence points towards local immunosuppressive treatment in mild disease, supplemented by systemic glucorticosteroids, ciclosporin or tumour necrosis factor-alpha inhibitors in severe cases. Other biologics are emerging.
Favorable response to infliximab treatment in a patient with active Crohn disease and pyoderma gangrenosum. [2015]Pyoderma gangrenosum is an extraintestinal manifestation of inflammatory bowel disease requiring meticulous medical and/or surgical treatment. We describe a 46-year-old patient who developed harsh pyoderma gangrenosum during a severe flare-up of the underlying Crohn disease of the terminal ileum. The patient responded favorably to treatment with infliximab-the chimeric antibody against tumor necrosis factor-alpha. The drug was administered intravenously at a dose 5 mg/kg/BW at baseline and weeks 2 and 6. Abdominal signs and symptoms as well as the skin lesions improved markedly before the second infusion. The patient is presently on infliximab maintenance regimen at a dose of 5 mg/kg/BW being administered as a 3 dose loading regimen at 0, 2 and 6 weeks with a treatment-free interval of 10 weeks until the next loading dose. The skin lesions remained in remission. Infliximab is a promising therapeutic modality for patients with Crohn disease and pyoderma gangrenosum.
[Current situation and the latest progress in the treatment of pyoderma gangrenosum]. [2022]Pyoderma gangrenosum (PG) is a rare chronic inflammatory non-infectious skin dermatosis, and there is no clear treatment guideline for this disease at home and abroad. There are a variety of clinical treatment methods for PG, including local therapy and systemic application of glucocorticoids, immunosuppressants, intravenous immuno- globulin, and biologics. Glucocorticoids are the first-line drugs commonly used in clinical practice, and immunosuppressants can be used alone or in combination with glucocorticoids. In recent years, more and more evidence has shown that biologics are a new trend in the treatment of PG, mainly including tumor necrosis factor ฮฑ inhibitors, interleukin-1 (IL-1) inhibitors, IL-12/23 inhibitors, IL-17 inhibitors, rituximab, and small molecular inhibitors. This article summarizes the current status and latest progress in the treatment of PG, hoping to provide clinicians with ideas for the treatment of PG.