Long-term Spesolimab Treatment for Hidradenitis Suppurativa

Recruiting at 24 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: Spesolimab

Must not be taking: Restricted medications

Disqualifiers: Pregnancy, Severe conditions, 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: 2

Duration: 104 weeks

45 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use any restricted medication or drugs that might interfere with the study, as determined by the investigator.

How is the drug Spesolimab different from other treatments for hidradenitis suppurativa?

Spesolimab is unique because it targets a different part of the immune system compared to other treatments like adalimumab, which is a TNF-α inhibitor. Spesolimab works by blocking interleukin-36, a protein involved in inflammation, offering a novel approach for patients who may not respond well to existing therapies. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial involves adults with hidradenitis suppurativa who previously took part in a spesolimab study. Participants receive spesolimab injections regularly over a long period. The study aims to see if the drug is safe and effective over time by reducing inflammation and symptoms.

Eligibility Criteria

Adults with hidradenitis suppurativa who were in a prior spesolimab study can join. They must have finished the previous trial without early stoppage, agree to birth control if applicable, and not be planning pregnancy or major surgery. Those with severe health issues or allergies to the drug are excluded.

Inclusion Criteria

You cannot have participated in a previous trial for the same condition without completing the treatment.

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

Woman 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. A list of contraception methods meeting these criteria is provided in the patient information and consent form.

Exclusion Criteria

I haven't taken any medication that could affect the study since my last trial visit.

I do not have any severe or worsening health conditions affecting my organs or mental health.

I am not pregnant, nursing, or planning to become pregnant during the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spesolimab injections every 2 weeks for 2 years

104 weeks

Visits every 2 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Spesolimab

Trial Overview The trial tests long-term safety and effectiveness of spesolimab for hidradenitis suppurativa over approximately 2 years and 4 months. Participants receive bi-weekly injections and undergo regular health checks to monitor their skin condition's severity.

Participant Groups

Group I: Prior Spesolimab (PS) Experimental Treatment 2 Interventions

Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

Group II: Prior Placebo (PP) Experimental Treatment 3 Interventions

Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

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

In a study of 94 patients with hidradenitis suppurativa who switched from the original adalimumab (ADAO) to the biosimilar ABP 501, 33.3% experienced adverse events or loss of response within 12 to 14 weeks after the switch.

The findings suggest that switching from ADAO to ABP 501 can significantly impact treatment effectiveness, particularly for patients on remission maintenance therapy, indicating that such switches should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response-Data from the German HS Registry HSBest. Kirsten, N., Ohm, F., Gehrdau, K., et al.[2022]

In a review of 12 randomized controlled trials involving 2915 patients, adalimumab and bimekizumab were found to be effective treatments for moderate-to-severe hidradenitis suppurativa, showing significant improvement in clinical response compared to placebo at 12-16 weeks.

All evaluated biologics, including adalimumab, bimekizumab, and secukinumab, demonstrated similar safety profiles with no increased risk of adverse effects compared to placebo, making them viable options for patients with refractory hidradenitis suppurativa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. Tsai, YC., Hung, CY., Tsai, TF.[2023]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Improvement of overlapping hidradenitis suppurativa and ankylosing spondylitis after the introduction of adalimumab. [2019]

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

A case paradoxical hidradenitis suppurativa with janus kinase inhibitor, literature review and pooled analysis of biological agent-induced HS. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

An Anti-Interleukin-17A Monoclonal Antibody, Ixekizumab, in the Treatment of Resistant Hidradenitis Suppurativa: A Case Series. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response-Data from the German HS Registry HSBest. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. [2023]