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Monoclonal Antibodies

Izokibep for Hidradenitis Suppurativa

Phase 3

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

18 to 75 years of age

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

Must not have

Other active skin disease or condition that could interfere with study assessments

History of active inflammatory bowel disease (IBD) OR symptoms within the last year that may be suggestive of IBD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial looks at a small protein molecule (izokibep) to treat Hidradenitis Suppurativa, a chronic skin condition. It includes people who haven't tried TNFi and those who couldn't tolerate it.

Who is the study for?

This trial is for adults aged 18-75 with active Hidradenitis Suppurativa (HS), who've had it for at least 6 months, and have at least 5 abscesses or nodules. Participants must not have a high count of draining fistulas, other interfering skin conditions, recent surgeries, certain infections like HIV or TB, uncontrolled diseases, risk of self-harm, chronic pain unrelated to HS, cancer in the last 5 years or signs of IBD.

What is being tested?

The study tests Izokibep—a molecule targeting interleukin 17A—against a placebo in people with HS. It includes those new to TNF inhibitors and those who didn't respond well to them. Participants will be randomly assigned to receive either Izokibep or a placebo while monitoring their condition.

What are the potential side effects?

Potential side effects may include reactions related to immune system changes due to interleukin inhibition such as increased infection risk and possibly inflammation-related symptoms; however specific side effects are not listed.

Eligibility Criteria

Inclusion Criteria

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

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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 antiseptics.

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 skin conditions that could affect the study.

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I have had symptoms or a diagnosis of inflammatory bowel disease in the past year.

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I have chronic pain not related to hidradenitis suppurativa.

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I have a serious illness that is not under control.

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

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I was diagnosed with cancer within the last 5 years.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

Participants will receive izokibep QW from Day 1 to Week 51.

Group II: Group 1Experimental Treatment2 Interventions

Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Izokibep

2022

Completed Phase 2

~220