Spesolimab for Pustular Psoriasis

Not currently recruiting at 56 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Boehringer Ingelheim

Disqualifiers: Plaque psoriasis, Erythrodermic psoriasis, SAPHO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 2

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medicine called spesolimab to determine its effectiveness for people with generalized pustular psoriasis (GPP), a serious skin condition causing painful flare-ups. Participants will receive a dose of spesolimab through an IV shortly after a flare begins, with a possible second dose a week later if needed. The study aims to assess how well the medicine manages flares and monitors any side effects. It seeks adults who frequently experience GPP flare-ups. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective treatment benefits more patients.

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. However, it mentions that treatment with any drug likely to interfere with the trial may be a reason for exclusion, so it's best to discuss your current medications with the trial doctors.

What is the safety track record for spesolimab?

Research shows that spesolimab is generally safe for people with generalized pustular psoriasis (GPP). Studies have found that spesolimab can quickly improve GPP symptoms. Most patients tolerate the treatment well.

Spesolimab is approved for treating GPP in adults and teens aged 12 and older, indicating a good safety record. While some side effects can occur, they are usually mild. Doctors in these studies regularly monitored patients' health, and most reported few problems.

Overall, spesolimab has demonstrated positive safety results, making it a promising option for managing GPP flares. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Spesolimab is unique because it targets the interleukin-36 receptor, a key player in the inflammatory process of Generalized Pustular Psoriasis (GPP), offering a more focused approach than traditional treatments. Unlike standard options like systemic steroids or immune suppressants, which broadly dampen the immune response, spesolimab works by blocking a specific pathway involved in the flare-ups of GPP. This targeted mechanism not only has the potential to be more effective but may also result in fewer side effects, making it an exciting option for patients and researchers alike.

What is the effectiveness track record for spesolimab in treating generalized pustular psoriasis?

Research has shown that spesolimab effectively treats generalized pustular psoriasis (GPP). One study found that spesolimab quickly and consistently improved symptoms during GPP flare-ups. Another analysis revealed that spesolimab, also known as SPEVIGO®, can enhance how patients feel and function. Over 48 weeks, spesolimab reduced the likelihood of new GPP flare-ups compared to a placebo. These findings support using spesolimab to effectively manage GPP. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Adults with a serious skin condition called generalized pustular psoriasis (GPP) who frequently experience flares can join this study. They must have a history of GPP documented by specific criteria and be willing to use effective birth control if applicable. People under 18 or those not able to consent are excluded.

Inclusion Criteria

I frequently experience severe GPP flares.

Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly

I have signed and understand the consent form for this trial.

Exclusion Criteria

Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)

Further exclusion criteria apply.

My liver tests are not severely abnormal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of spesolimab as an infusion on the first day of a GPP flare, with a possible second dose 1 week later

1-2 weeks

2 visits (in-person)

Monitoring

Doctors regularly examine participants' skin for signs of GPP and take blood samples to assess treatment efficacy and safety

Ongoing during study

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spesolimab

Trial Overview The trial is testing Spesolimab, given as an infusion into the vein at the start of a GPP flare, possibly followed by a second dose after one week. The study monitors how well Spesolimab treats these flares and checks for any health changes through regular skin exams and blood tests.

How Is the Trial Designed?

Group I: GPP Patients Experimental Treatment 1 Intervention

Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab.

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

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11298804/

Spesolimab for generalized pustular psoriasis: a review of two ... These data demonstrate the efficacy and safety of spesolimab in providing rapid and sustained clinical improvement for patients with GPP flares, ...

2. boehringer-ingelheim.com boehringer-ingelheim.com/us/new-analyses-explore-impact-spevigo-gpp-aad

New analyses explore impact of SPEVIGO in GPP at AAD New analyses on the potential impact of SPEVIGO® in generalized pustular psoriasis patient-reported outcomes presented at AAD 2025. Ridgefield, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04399837

NCT04399837 | A Study to Test Whether BI 655130 ... This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2111563

Trial of Spesolimab for Generalized Pustular Psoriasis We conducted a phase 2 randomized trial (Effisayil 1) to investigate the efficacy and safety of spesolimab as compared with placebo in patients ...

5. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/products/spevigo/efficacy/gpp-treatment

GPP Treatment Efficacy | Spevigo® (spesolimab-sbzo) ... 48-week trial data 1-3 SPEVIGO SC (subcutaneous) reduced the risk of GPP flares over 48 weeks vs placebo 1,2

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04399837

NCT04399837 | A Study to Test Whether BI 655130 ... The purpose of the study is to test 3 different doses of a medicine called spesolimab and to see whether it helps to prevent GPP flare-ups.

7. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/products/spevigo/safety/gpp-treatment

Spevigo® SC Safety Profile SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least ...

8. prnewswire.com prnewswire.com/news-releases/new-analyses-on-the-potential-impact-of-spevigo-in-generalized-pustular-psoriasis-patient-reported-outcomes-presented-at-aad-2025-302395652.html

New analyses on the potential impact of SPEVIGO® in ... Spesolimab improves quality of life as measured by Dermatology Life Quality Index (DLQI) in generalized pustular psoriasis (GPP) over time: ...