Spesolimab for Pustular Psoriasis

Recruiting at 65 trial locations

Overseen By Boehringer Ingelheim

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: Spesolimab

Must not be taking: Restricted medications

Disqualifiers: Hepatic disease, Heart disease, Infections, TB, Malignancy, 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: Unknown

Duration: 252 weeks

132 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is open to people with generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027). The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolimab. The study also tests whether spesolimab helps improve GPP symptoms and how quickly the symptoms improve after a flare-up. Every participant gets spesolimab for almost 5 years (252 weeks). Depending on their symptoms and whether they had a GPP flare during the previous trial, they get spesolimab every few weeks. When participants have a GPP flare during this trial, they get spesolimab as an infusion into a vein. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. To assess the study endpoints, doctors regularly check participants' skin.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications are restricted, except for methotrexate, cyclosporine, or retinoids if started after a GPP flare in the previous trial.

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

Research shows that spesolimab is effective in treating generalized pustular psoriasis flares, with 62.5% of patients achieving no visible pustules after one week, compared to 7.7% with a placebo. Additionally, 50% of patients had clear or almost clear skin, demonstrating rapid improvement. ^{1 2 3 4 5}

Is spesolimab safe for humans?

Spesolimab has been studied for treating generalized pustular psoriasis, and it showed an acceptable safety profile in clinical trials. Most patients experienced at least one adverse event, but the treatment was generally well-tolerated. ^{1 2 4 5 6}

How is the drug spesolimab unique for 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 offers a novel approach compared to other treatments by directly targeting the immune pathway involved in GPP. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for men and women who previously participated in a spesolimab study without early dropout. They must consent to continue treatment, use effective birth control if of childbearing potential, and not have moderate/severe psoriasis flare symptoms or certain infections like HIV or tuberculosis.

Inclusion Criteria

Women of childbearing potential 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. A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

Signed and dated written informed consent and assent for the current trial 1368-0025, in accordance with ICH-GCP and local legislation prior to admission to the current trial

I completed a previous spesolimab trial without stopping early and am willing to continue treatment.

Exclusion Criteria

I haven't taken any medication that could affect this study, except for certain allowed drugs after a specific treatment.

My liver tests are not severely abnormal.

I have no active cancers except for certain skin cancers or cervical cancer that's been treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spesolimab treatment every few weeks for up to 252 weeks, with adjustments based on symptoms and flare-ups

252 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Spesolimab

Trial Overview The trial tests the long-term safety and effectiveness of Spesolimab in patients with Generalized Pustular Psoriasis (GPP) who completed prior Spesolimab trials. It aims to understand how well the drug works over an extended period.

Participant Groups

Group I: Spesolimab (every 6 weeks) Experimental Treatment 1 Intervention

Group II: Spesolimab (every 4 weeks) Experimental Treatment 1 Intervention

Group III: Spesolimab (every 12 weeks) Experimental Treatment 1 Intervention

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]