Izokibep for Hidradenitis Suppurativa

No longer recruiting at 98 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called izokibep for individuals with active Hidradenitis Suppurativa (HS), a painful skin condition characterized by recurring lumps. Izokibep may benefit those who haven't responded well to certain antibiotics or cannot use them. Participants will either begin with a placebo (a substance with no therapeutic effect) before switching to izokibep, or receive izokibep throughout the trial. The trial seeks individuals who have had HS for at least six months and have painful lumps in at least two body areas. As a Phase 3 trial, this study represents the final step before FDA approval, offering access to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that izokibep is likely to be safe for humans?

Research has shown that izokibep is generally well-tolerated. In past studies, it demonstrated a good safety record, causing few serious side effects. No increased risk of infections, such as Candida, a type of fungal infection, was observed. Earlier trials with healthy individuals and those with psoriasis, a skin condition, also found no major safety issues. This suggests that izokibep might be safe for people with hidradenitis suppurativa, but further research is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hidradenitis Suppurativa?

Izokibep is unique because it targets IL-17A, a protein involved in inflammatory pathways, which is different from the TNF inhibitors commonly used for treating Hidradenitis Suppurativa. This new mechanism of action offers hope for patients who may not respond well to current treatments like adalimumab. Additionally, izokibep is administered as a weekly subcutaneous injection, which could provide a more convenient dosing schedule compared to some existing medications. Researchers are excited about izokibep because it has the potential to offer a novel approach to managing this chronic skin condition, improving outcomes for patients who have limited options.

What evidence suggests that izokibep might be an effective treatment for Hidradenitis Suppurativa?

Research has shown that izokibep holds promise for treating hidradenitis suppurativa (HS). In one study, 24% of patients who took izokibep experienced significant improvement, known as HiSCR90, compared to only 12% who took a placebo. Additionally, many patients reached the HiSCR75 level, indicating a strong reduction in HS symptoms. These improvements occurred over 16 weeks, suggesting that izokibep can effectively lessen the severity of HS symptoms. In this trial, participants in Group 1 will initially receive a placebo before switching to izokibep, while participants in Group 2 will receive izokibep from the start. The evidence suggests that izokibep could be a helpful option for people with moderate to severe HS. ^{1 2 3 4 6}

Who Is on the Research Team?

Shephard Mpofu

Principal Investigator

ACELYRIN Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. firstwordpharma.com firstwordpharma.com/story/6094904

Positive 16-week Phase 3 Data of Izokibep in Hidradenitis ... In higher order endpoints, 24% of patients treated with izokibep achieved HiSCR90, compared to 12% with placebo (p<0.05), and 21% of patients ...

2. affibody.se affibody.se/mfn_news/positive-16-week-phase-3-data-of-izokibep-in-hidradenitis-suppurativa-to-be-presented-at-eadv-2025-late-breaking-session/

Positive 16-week Phase 3 Data of Izokibep in Hidradenitis ... The study included 258 randomized patients with moderate-to-severe HS. The primary endpoint was the proportion of patients achieving HiSCR75 at ...

3. hcplive.com hcplive.com/view/izokibeb-effective-16-weeks-among-patients-moderate-severe-hidradenitis-suppurativa

Izokibep Effective in 16 Weeks Among Patients with ... This study highlights improvements with izokibep for HS, sustained or improved across disease measures through to Week 16.

4. imagenebio.com imagenebio.com/press_releases/positive-izokibep-clinical-data-in-hidradenitis-suppurativa/

Positive Izokibep Clinical Data in Hidradenitis Suppurativa Izokibep demonstrated higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR), where low-to-no placebo responses have been reported historically.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05905783

NCT05905783 | Hidradenitis Suppurativa Study of Izokibep This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10187109/

Izokibep: Preclinical development and first-in-human study of ... Izokibep was well tolerated with no meaningful safety concerns identified in healthy volunteers and patients with psoriasis. Rapid efficacy was ...