Spesolimab for Pustular Psoriasis

Recruiting at 47 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

42 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug spesolimab for treating pustular psoriasis?

Research shows that spesolimab, a drug targeting the immune system, helped clear skin pustules in patients with generalized pustular psoriasis flares. In a study, 62.5% of patients treated with spesolimab had no visible pustules after one week, compared to only 7.7% of those given a placebo. ^{1 2 3 4 5}

Is spesolimab safe for treating generalized pustular psoriasis?

Spesolimab has been shown to have an acceptable safety profile in clinical trials for treating generalized pustular psoriasis flares, with most patients experiencing at least one mild adverse event. ^{1 2 4 5 6}

How is the drug spesolimab unique in treating pustular psoriasis?

Spesolimab is unique because it is the first targeted treatment specifically studied for generalized pustular psoriasis (GPP) flares, working as an interleukin-36 receptor antagonist to rapidly clear pustules and improve skin condition. It has shown rapid and sustained improvements in patients compared to placebo, making it a novel option for this condition. ^{1 2 3 5 6}

What is the purpose of this trial?

This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Spesolimab: First Approval. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of spesolimab in Asian patients with a generalized pustular psoriasis flare: Results from the randomized, double-blind, placebo-controlled Effisayil™ 1 study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Rapid and sustained improvements in Generalized Pustular Psoriasis Physician Global Assessment scores with spesolimab for treatment of generalized pustular psoriasis flares in the randomized, placebo-controlled Effisayil 1 study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. [2021]

5. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy of spesolimab for the treatment of generalized pustular psoriasis flares across pre-specified patient subgroups in the Effisayil 1 study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. [2023]