Long-term Spesolimab Treatment for Hidradenitis Suppurativa

No longer recruiting at 30 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if spesolimab (an injection) is safe and effective for long-term treatment of hidradenitis suppurativa, a chronic skin condition causing painful lumps. Participants receive injections every two weeks and are monitored for health changes. Individuals who completed a previous spesolimab study for hidradenitis suppurativa without dropping out are eligible to join. This trial suits those who participated in the earlier study and wish to continue exploring this treatment option. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research has shown that spesolimab is generally safe for treating hidradenitis suppurativa (HS), a skin condition. In one study, patients who took spesolimab experienced fewer skin problems and their condition improved over time. Another study found that patients had lasting relief from symptoms, and the treatment was well-tolerated for a year.

Patients have reported that spesolimab helps reduce pain related to HS, with few serious side effects. Some individuals have found success with spesolimab when other treatments failed, suggesting it could be a safe option.

Overall, while no treatment is without risks, evidence suggests that spesolimab is generally safe and well-tolerated for people with moderate to severe HS. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hidradenitis suppurativa?

Most treatments for hidradenitis suppurativa focus on reducing inflammation or controlling bacterial infections, often using antibiotics, hormonal therapy, or biologics like adalimumab. Spesolimab is unique because it targets the interleukin-36 receptor, a mechanism that is not addressed by current treatments. This novel approach could provide relief for patients who haven't had success with other therapies. Researchers are excited about spesolimab because it offers a new way to potentially manage this challenging condition with a targeted action that may lead to improved outcomes.

What evidence suggests that spesolimab might be an effective treatment for hidradenitis suppurativa?

Research has shown that spesolimab can help people with hidradenitis suppurativa, a skin condition that causes painful lumps. Studies have found that spesolimab works by blocking a protein called interleukin-36, which plays a role in inflammation. In one study, patients who received spesolimab showed noticeable improvements in their symptoms over 12 weeks. Another study found that spesolimab effectively treated skin flare-ups in people with generalized pustular psoriasis. These findings suggest that spesolimab could be a promising option for managing symptoms in people with hidradenitis suppurativa. Participants in this trial will receive spesolimab, with dosing based on their previous treatment in the 1368-0052 Proof of Concept Clinical (PoCC) trial. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04876391

NCT04876391 | A Study Investigating Long-term Treatment ... A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04762277

NCT04762277 | A Study to Test Whether Spesolimab ... The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa.

3. academic.oup.com academic.oup.com/bjd/article/191/4/508/7641056

Proof-of-concept study exploring the effect of spesolimab in ... This 12-week study explored the effects of spesolimab, which inhibits interleukin (IL)-36 signalling, in patients with moderate-to-severe ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38576350/

a randomized double-blind placebo-controlled clinical trial Proof-of-concept study exploring the effect of spesolimab in patients with moderate-to-severe hidradenitis suppurativa: a randomized double- ...

5. boehringer-ingelheim.com boehringer-ingelheim.com/ca/newly-published-trial-results-showed-spesolimab-significantly-improved-signs-and-symptoms-flare-rare

Newly published trial results showed spesolimab ... Spesolimab, a novel IL-36R antibody treatment, was effective in rapidly treating adult patients with generalized pustular psoriasis (GPP) experiencing a flare.

6. jaad.org jaad.org/article/S0190-9622(24)01378-1/fulltext

52676 Safety and efficacy over one year of spesolimab ... In this analysis of the OLE, the safety profile of spesolimab was favorable, and there was a sustained reduction in all lesion types and IHS4 score over one ...

7. ijdvl.com ijdvl.com/spesolimab-for-treatment-of-severe-hidradenitis-suppurativa-in-the-real-world/

Spesolimab for treatment of severe hidradenitis ... We present a case series indicating the efficacy and safety of spesolimab in four patients with severe HS (Hurley III) who were unresponsive to other ...