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

Must not have

Uncontrolled, clinically significant system disease

Malignancy within 5 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part b period 1: screening (day -28) to follow-up (week 39)

Summary

This trial is testing Izokibep, a drug that blocks inflammation-causing proteins, in adults with moderate to severe hidradenitis suppurativa. The drug aims to reduce inflammation by targeting the IL-17A protein.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled serious illnesses.

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I was diagnosed with cancer within the last 5 years.

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I do not have any skin conditions that could affect the study.

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I do not have an active infection or a history of serious infections.

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I have been diagnosed with HIV.

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I have a history of diseases that affect the protective covering of nerves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part b period 1: screening (day -28) to follow-up (week 39)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part b period 1: screening (day -28) to follow-up (week 39)

This trial's timeline: 3 weeks for screening, Varies for treatment, and part b period 1: screening (day -28) to follow-up (week 39) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Hidradenitis Suppurativa Clinical Response (HiSCR75)

Part B: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Secondary study objectives

Part B Period 1: Incidence of Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation

Part B Period 1: Incidence of Treatment-emergent Adverse Events (TEAEs) of Special Interest

Part B: Participants Achieving HiSCR100

+5 more

Side effects data

From 2024 Phase 2 trial • 205 Patients • NCT05355805

54%

Injection site erythema

28%

Injection site pruritus

16%

Nasopharyngitis

16%

Injection site swelling

14%

Headache

Upper respiratory tract infection

Oropharyngeal pain

Back pain

Injection site pain

Injection site inflammation

Nausea

Injection site oedema

Influenza

Urinary tract infection

Viral upper respiratory tract infection

Thermal burn

Muscle spasms

Toothache

Migraine

Arthritis

Dysmenorrhoea

Skin papilloma

Diarrhoea

Groin pain

Tonsillitis

Injection site urticaria

Injection site irritation

Asthenia

Epstein-Barr virus infection

Axillary pain

Herpes simplex

Cutaneous vasculitis

Pyrexia

Eczema

Fall

Fatigue

Injection site discolouration

Erythema nodosum

Tooth disorder

Hot flush

Amenorrhoea

COVID-19

Abdominal discomfort

Arthralgia

Tinea pedis

Orthostatic hypotension

Gastroenteritis viral

Injection site hypersensitivity

Gastrointestinal viral infection

Tonsillitis bacterial

Dizziness

Joint dislocation

Conjunctivitis allergic

Injection site warmth

Intertrigo

Acute kidney injury

Bradycardia

Autoimmune thyroiditis

Proteinuria

SARS-CoV-2 test positive

Alanine aminotransferase increased

Tooth fracture

Conjunctival haemorrhage

Foot fracture

Postoperative wound infection

Urticaria

Injection site reaction

Injection site bruising

100%

80%

60%

40%

20%

Study treatment Arm

Part B Izokibep 160 mg QW - Period 1

Part B Izokibep 160 mg Q2W - Period 1

Part A Izokibep 160 mg QW

Part B Placebo QW/Q2W - Period 1

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

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

Participants will receive izokibep every week 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 every week 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

~220

0 / 10Eligibility 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].