Spesolimab for Pustular Psoriasis

Not currently recruiting at 80 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term tolerability of spesolimab in individuals with generalized pustular psoriasis (GPP). Researchers aim to determine if spesolimab can reduce symptoms and manage flare-ups over time. Participants receive spesolimab through infusions for nearly five years, with doses adjusted according to their symptoms. Those who completed a previous spesolimab trial and continue to experience GPP symptoms may qualify for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

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.

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

Research has shown that spesolimab has been tested in people with generalized pustular psoriasis (GPP). In one study, about 17% of patients who took spesolimab reported infections, compared to 6% of those who took a placebo (a harmless pill with no effect). This indicates that some people might experience infections while using this treatment.

Another study assessed the safety of spesolimab and found that most people tolerate it well. However, like any medicine, it can cause side effects. The most common ones include fatigue, headaches, or skin reactions at the injection site. These side effects can vary based on the dose and individual response.

The FDA has approved spesolimab for treating GPP flares, indicating confidence in its safety. This approval means it has undergone thorough testing to ensure its safety for this condition. However, individual reactions can differ, so monitoring for any health changes and consulting a doctor if concerns arise is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pustular psoriasis?

Researchers are excited about Spesolimab for pustular psoriasis because it works differently from current treatments. While most standard therapies target general inflammation or the immune system broadly, Spesolimab specifically blocks the interleukin-36 receptor, which plays a key role in the inflammatory process of pustular psoriasis. This targeted approach not only has the potential to be more effective but may also reduce some side effects associated with less specific treatments. Additionally, Spesolimab is being tested in different dosing schedules (every 4, 6, or 12 weeks), offering potential flexibility in treatment plans. This could mean more personalized care options for patients, which is a significant advancement in managing this challenging condition.

What evidence suggests that spesolimab might be an effective treatment for pustular psoriasis?

Research has shown that spesolimab offers promising results for treating generalized pustular psoriasis (GPP). In one study, 71% of patients achieved clear or almost clear skin after treatment. Participants also reported an overall improvement in well-being with spesolimab. Further analysis found that spesolimab significantly improved quality of life over time for those with GPP. These findings suggest that spesolimab could effectively manage GPP symptoms and enhance patient well-being. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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 ... Efficacy data are presented in Figure 2 . A GPPGA score of 0 or 1 (clear or almost clear skin) was attained in five of the seven patients (71%) ...

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.

3. jaad.org jaad.org/article/S0190-9622(25)00184-7/fulltext

Effect of spesolimab on sustained disease control in ... Spesolimab improves patient-reported outcomes in patients with generalized pustular psoriasis: results from the Effisayil 1 study. J Eur Acad ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04399837

A Study to Test Whether BI 655130 (Spesolimab) Prevents ... 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.

5. 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: ...

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

GPP Treatment Safety Profile | Spevigo® (spesolimab- ... Adverse reactions shown are for the recommended SPEVIGO SC dose only. For a full list of adverse drug reactions, please refer to the Prescribing Information.

8. 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 ...