Izokibep for Hidradenitis Suppurativa

Recruiting at 92 trial locations

Overseen By Donald Betah

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ACELYRIN Inc.

Must be taking: Topical antiseptics

Disqualifiers: IBD, Chronic pain, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 51 weeks

258 Participants Needed

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

Shephard Mpofu

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

Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive placebo or izokibep as a subcutaneous injection weekly

51 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Izokibep

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+