What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS) include IL-17 inhibitors such as secukinumab and ixekizumab. Known side effects of these treatments can include nasopharyngitis, headache, and injection site reactions. Additionally, there is a risk of inflammatory bowel disease events. Other treatments for HS, such as antibiotics and TNF inhibitors, may cause gastrointestinal issues, increased risk of infections, and injection site reactions. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Hidradenitis Suppurativa, with a focus on biologic therapies. One notable approval is for adalimumab, a TNF-alpha inhibitor, which has been shown to reduce inflammation and lesions in HS patients. While IL-17A inhibitors like secukinumab and ixekizumab are approved for conditions such as psoriasis, they are not yet FDA-approved specifically for HS. However, their mechanism of action, which involves inhibiting the IL-17A pathway, is similar to that of Izokibep, currently under investigation for HS treatment.

What other types of research exist?

Promising novel alternatives to Izokibep for Hidradenitis Suppurativa patients include Tezepelumab, which targets thymic stromal lymphopoietin and is under development for severe asthma, and Iberdomide, which modulates immune pathways and has shown efficacy in systemic lupus erythematosus. Both treatments are in advanced clinical trials and may offer new therapeutic options for HS patients.

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Interleukin 17A Inhibitor

Izokibep for Hidradenitis Suppurativa

Phase 2

Waitlist Available

Research Sponsored by ACELYRIN Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas , one of which is Hurley Stage II or III.

18 years to 75 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: day 1, weeks 4, 8, 12, 16, 24, 32 and at follow-up (weeks 39 and 45)

Awards & highlights

Study Summary

This trial is testing a new drug to treat hidradenitis suppurativa, a painful skin condition. The drug is given as a shot, and the trial will test how well it works and if it has any side effects.

Who is the study for?

Adults aged 18-75 with moderate to severe Hidradenitis Suppurativa (HS), having lesions in at least two areas, one being Hurley Stage II or III. Participants must have had HS for over a year, not responded well to oral antibiotics, and be willing to use daily antiseptics and keep a pain diary.Check my eligibility

What is being tested?

The trial is testing Izokibep, an inhibitor targeting interleukin 17A (IL-17A) against a placebo. It aims to assess the drug's effectiveness and safety when injected under the skin in those with HS who haven't seen improvement from standard treatments.See study design

What are the potential side effects?

While specific side effects of Izokibep are not listed here, inhibitors like it can potentially cause injection site reactions, increased risk of infections due to immune system suppression, allergic reactions, or other immune-related conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have skin lesions in 2 different areas, with at least one being moderate to severe.

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I am between 18 and 75 years old.

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I have skin lesions in 2 different areas, with at least one area being moderate to severe.

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I agree to use daily skin cleaning products.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part b: day 1, weeks 4, 8, 12, 16, 24, 32 and at follow-up (weeks 39 and 45)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part b: day 1, weeks 4, 8, 12, 16, 24, 32 and at follow-up (weeks 39 and 45)

This trial's timeline: 3 weeks for screening, Varies for treatment, and part b: day 1, weeks 4, 8, 12, 16, 24, 32 and at follow-up (weeks 39 and 45) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Hidradenitis suppurativa clinical response (HiSCR75)

Part B: Hidradenitis suppurativa clinical response (HiSCR75)

Secondary outcome measures

Part A: Incidence of clinically significant changes in laboratory values

Part A: Incidence of clinically significant changes in vital signs

Part A: Incidence of serious adverse events (SAEs)

+14 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B (Double-blind) izokibep every weekExperimental Treatment1 Intervention

Participants will receive izokibep weekly for 31 weeks.

Group II: Part B (Double-blind) izokibep every other weekExperimental Treatment1 Intervention

Participants will receive izokibep every other week for 30 weeks.

Group III: Part A (Open-label) izokibep every weekExperimental Treatment1 Intervention

Participants will receive izokibep every week from Day 1 through Week 31

Group IV: Part B (Double-blind) placebo every other weekPlacebo Group1 Intervention

Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.

Group V: Part B (Double-blind) placebo every weekPlacebo Group1 Intervention

Participants will receive placebo weekly up to Week 15, then izokibep from Week 16 to Week 31.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Izokibep

2022

Completed Phase 2

~190

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hidradenitis Suppurativa (HS) treatments often target inflammatory pathways to reduce symptoms and prevent flare-ups. Izokibep, a selective inhibitor of interleukin 17A (IL-17A), works by blocking this specific cytokine, which plays a crucial role in the inflammatory process of HS. By inhibiting IL-17A, Izokibep can potentially reduce the chronic inflammation and lesions characteristic of HS. Other treatments, such as TNF-alpha inhibitors (e.g., infliximab) and IL-23 inhibitors, also target specific cytokines involved in the inflammatory response. These treatments are significant for HS patients as they directly address the underlying inflammation, offering relief from pain, reducing the frequency of flare-ups, and improving the overall quality of life.

[Hidradenitis suppurativa. Response to treatment with infliximab].