Spesolimab for Hidradenitis Suppurativa

Recruiting at 200 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Boehringer Ingelheim

Must be taking: Antibiotics

Must not be taking: Immunosuppressive biologics

Disqualifiers: Pregnancy, Organ transplant, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

209 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests spesolimab, a drug that may help adults with moderate to severe hidradenitis suppurativa (HS). It works by calming the immune system to reduce inflammation and heal the skin. The study aims to see if spesolimab is effective and safe for these patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot continue any restricted medications or drugs that might interfere with the trial. It's best to discuss your current medications with the trial doctors to see if they are allowed.

Is spesolimab safe for humans?

Spesolimab has been studied for treating generalized pustular psoriasis and has shown an acceptable safety profile, meaning it is generally safe for humans. In clinical trials, some patients experienced adverse events (unwanted effects), but these were similar to those seen with a placebo. ^{1 2 3 4 5}

What makes the drug Spesolimab unique for treating hidradenitis suppurativa?

Spesolimab is unique because it targets the immune system differently than the currently approved drug adalimumab, which is a TNF-α inhibitor. Spesolimab is an anti-interleukin-36 receptor antibody, which may offer a new approach for patients who do not respond well to existing treatments. ^{6 7 8 9 10}

Eligibility Criteria

Adults with moderate to severe hidradenitis suppurativa (HS) can join this trial. They must have had an inadequate response to antibiotics, be biologic naive or only exposed to TNF inhibitors for HS treatment, and not have used other immunosuppressive biologics. Pregnant women and those with certain allergies or a history of cancer within the last 5 years are excluded.

Inclusion Criteria

I have moderate to severe hidradenitis suppurativa.

I have not used biologic treatments or have used TNF inhibitors for my condition.

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

Exclusion Criteria

I haven't used any experimental drugs or devices in the last 30 days or 5 half-lives of the drug.

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

I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that was treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants are divided into 4 groups receiving different doses of spesolimab or placebo. Injections are administered weekly and later every 2 weeks.

16 weeks

Weekly visits initially, then every 2 weeks

Treatment Part 2

Participants are divided into 2 groups receiving a suitable dose of spesolimab or placebo. Placebo group switches to spesolimab after 4 months.

16 weeks

Weekly visits initially, then every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Placebo matching Spesolimab Formulation 1
• Placebo matching Spesolimab Formulation 2
• Spesolimab

Trial Overview The study tests if spesolimab helps people with HS. Participants are randomly assigned into groups receiving different doses of spesolimab or placebo via injections. After initial weekly treatments, they switch to every two weeks, and after four months, placebo groups start on spesolimab.

Participant Groups

Group I: Part II: Active (treatment) group Experimental Treatment 1 Intervention

Group II: Part I: Medium dose group Experimental Treatment 2 Interventions

Group III: Part I: Low dose group Experimental Treatment 2 Interventions

Group IV: Part I: High dose group Experimental Treatment 2 Interventions

Group V: Part II: Placebo group Placebo Group 1 Intervention

Group VI: Part I: Placebo group Placebo Group 2 Interventions

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]

In a Phase III trial involving 317 patients with moderate-to-severe chronic plaque psoriasis, BI 695501 (a biosimilar to Humira) showed equivalent efficacy to the reference product, with PASI 75 response rates of 68.2% for BI 695501 and 70.4% for adalimumab at week 16.

Both treatments demonstrated similar safety profiles, with comparable rates of treatment-emergent adverse events (41.5% for BI 695501 and 44.9% for adalimumab) and low rates of serious adverse events, indicating that BI 695501 is a safe alternative to the reference product.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study. Menter, A., Arenberger, P., Balser, S., et al.[2021]

Adalimumab and infliximab are the most studied treatments for moderate to severe hidradenitis suppurativa (HS), with clinical trials showing their efficacy, while other agents like anakinra and ustekinumab also demonstrate promise.

Adalimumab is currently the only biologic approved by the FDA for HS, and most treatments have a good safety profile, although infections are the most common side effect reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. Lim, SYD., Oon, HH.[2020]

References

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

Spesolimab: First Approval. [2022]

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

Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study. [2021]

3. 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]

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

Evaluation of efalizumab using safe psoriasis control. [2019]

5. 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]

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

Observational case series on adalimumab-induced paradoxical hidradenitis suppurativa. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Paradoxical psoriasiform reactions during treatment with adalimumab for hidradenitis suppurativa: Real-life experience and therapeutic response to other biological drugs. [2023]

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

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. [2020]

10. Poland pubmed.ncbi.nlm.nih.gov

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