Spesolimab for Hidradenitis Suppurativa

No longer recruiting at 144 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Boehringer Ingelheim

Must be taking: Spesolimab

Must not be taking: Immunomodulatory biologics

Disqualifiers: Pregnancy, HIV, Viral hepatitis, 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: 24

Duration: 78 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the tolerability and effectiveness of the drug spesolimab for treating hidradenitis suppurativa (HS), a chronic skin condition characterized by painful lumps. Participants will receive spesolimab injections every two weeks for approximately 1.5 years to evaluate its long-term benefits. Regular check-ups will monitor the severity of HS and any health issues. The trial is open to individuals who completed a previous spesolimab study for HS and are willing to continue treatment. As a Phase 2/3 trial, this study measures the treatment's effectiveness in a larger group and represents the final step before potential FDA approval, offering participants a chance to contribute to advancing HS treatment.

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

The trial requires that you do not use certain medications, like immunomodulatory biologics or investigational drugs, during the study. It's best to discuss your current medications with the trial team to see if they are allowed.

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

Research shows that spesolimab is generally safe for people with hidradenitis suppurativa (HS). Studies have found no deaths related to the treatment, indicating its safety. Another study reported that patients experienced fewer HS lesions over a year, with no major safety issues. Earlier research also showed that spesolimab helps reduce pain while remaining safe. These findings suggest that spesolimab is a safe choice for those considering joining a clinical trial. ^{1 2 3 4 5}

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

Unlike the standard treatments for hidradenitis suppurativa, which often include antibiotics or immunosuppressants, Spesolimab is a novel therapy that targets a specific pathway known as the IL-36 receptor. This mechanism is different because it specifically modulates the inflammatory process involved in the condition. Researchers are excited about Spesolimab because it has the potential to offer more precise control of inflammation, which could lead to better outcomes and fewer side effects compared to existing therapies.

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

Research has shown that spesolimab, the investigational treatment in this trial, might help treat moderate-to-severe hidradenitis suppurativa (HS). In an earlier study, patients experienced fewer types of skin lesions and improved scores on a scale measuring HS severity over a year. Another study found that just one or two doses of spesolimab reduced HS severity in several patients. The drug blocks a protein called interleukin-36, which plays a role in inflammation. Early results suggest that spesolimab could provide long-term benefits for people with HS, offering hope for better management of this challenging condition. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people with a skin condition called Hidradenitis Suppurativa (HS) who finished a previous spesolimab study without dropping out early. They must be within 16 weeks of their last spesolimab dose and women able to have children need to use effective birth control.

Inclusion Criteria

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

It has been less than 16 weeks since my last spesolimab treatment.

Participants who have completed treatment in the parent hidradenitis suppurativa (HS) spesolimab trial (1368-0098 (NCT05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this trial

Exclusion Criteria

I am not taking any medications that could affect my trial safety.

I am not pregnant, nursing, nor planning to become pregnant during the trial.

I haven't used any immune-boosting drugs or experimental treatments since my last trial visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spesolimab injections under the skin every 2 weeks for about 1.5 years

78 weeks

24 visits (in-person), 17 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Spesolimab

Trial Overview The trial tests long-term tolerance and effectiveness of Spesolimab in HS patients. Participants receive Spesolimab injections every two weeks for about 1.5 years, with the total study duration being around 2 years including both in-person and video call visits.

How Is the Trial Designed?

Group I: Patients treated in parent trial 1368-0100 Experimental Treatment 1 Intervention

Group II: Patients treated in Part II of parent trial 1368-0098 (NCT05819398) Experimental Treatment 1 Intervention

Group III: Patients treated in Part I of parent trial 1368-0098 (NCT05819398) 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+

Citations

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

a randomized double-blind placebo-controlled clinical trial In this study, we tested a drug called 'spesolimab' as a treatment for people with moderate-to-severe HS.

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. 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 ...

4. 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 ...

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

Spesolimab for treatment of severe hidradenitis ... Remarkably, all four patients exhibited a favourable response to one or two doses of 900 mg spesolimab in combination with other therapies, ...

6. link.springer.com link.springer.com/article/10.1007/s13555-024-01325-7

Analysis of Predefined Safety Events Across Spesolimab ... No deaths occurred in any trial. These data show that the safety profile of spesolimab is favourable. This aligns with results from the ...