Spesolimab for Hidradenitis Suppurativa

No longer recruiting at 231 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, spesolimab, to determine its effectiveness for people with moderate to severe hidradenitis suppurativa (HS), a skin condition causing painful lumps. The study consists of two parts: the first explores different doses of spesolimab, while the second focuses on the best dose identified. Participants receive either spesolimab (an experimental treatment) or a placebo, with those on placebo later switching to spesolimab. It is open to adults with HS who have painful lumps in at least two areas, excluding those who have previously taken certain other biologic medicines. As a Phase 2 trial, this research measures how well spesolimab works in an initial, smaller group, offering participants a chance to contribute to potential advancements in HS treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that spesolimab is generally well-tolerated. In one study, patients with moderate-to-severe hidradenitis suppurativa (HS) experienced symptom improvement and maintained a good safety record, with most not experiencing serious side effects. Another year-long study found that spesolimab was safe and helped reduce skin lesions.

These results suggest that spesolimab could be a safe treatment option for HS. However, like any treatment, some individuals might experience side effects, so doctors will closely monitor participants' health during the trial. Those interested in joining the trial should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Spesolimab for treating Hidradenitis Suppurativa because it targets the underlying inflammation differently than current treatments. Most standard options, like antibiotics and biologics, focus on reducing symptoms or controlling infection. However, Spesolimab works by blocking interleukin-36 receptor signaling, a pathway linked to the inflammatory process in the disease. This new mechanism of action could offer more effective relief for patients who haven't responded well to existing therapies. Additionally, Spesolimab's potential to be delivered as an injectable could provide improved convenience and adherence compared to some oral medications.

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

Research suggests that spesolimab might help treat hidradenitis suppurativa (HS). One study found that patients using spesolimab had fewer types of skin lesions and lower scores on a test measuring HS severity. Another study showed positive results in patients who received one or two doses of spesolimab. Spesolimab blocks a protein called interleukin-36, believed to contribute to HS inflammation. Early findings indicate that it could help reduce the painful symptoms of this condition. Participants in this trial will receive different doses of spesolimab or a placebo to further evaluate its effectiveness. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Spesolimab medium dose group Experimental Treatment 2 Interventions

Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).

Group II: Spesolimab low dose group Experimental Treatment 2 Interventions

Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.

Group III: Spesolimab high dose group Experimental Treatment 2 Interventions

Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).

Group IV: Placebo Placebo Group 3 Interventions

Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).

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]

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]

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, ...