Izokibep for Hidradenitis Suppurativa

Recruiting at 92 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ACELYRIN Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.

Research Team

Donald Betah

Principal Investigator

ACELYRIN Inc.

Eligibility Criteria

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.

Inclusion Criteria

My HS didn't improve with oral antibiotics, or it came back after stopping them, or I can't tolerate them.

I am between 18 and 75 years old.

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

Exclusion Criteria

I have chronic pain not related to hidradenitis suppurativa.

I was diagnosed with cancer within the last 5 years.

I do not have active tuberculosis or fungal infection, or I have completed treatment for it.

Treatment Details

Interventions

• Izokibep (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Group 2 Experimental Treatment 1 Intervention

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

Group II: Group 1 Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

ACELYRIN Inc.

Lead Sponsor

Trials

9

Recruited

1,100+