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Monoclonal Antibodies

Izokibep for Hidradenitis Suppurativa

Phase 3
Recruiting
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 screening (day -28) to follow-up (week 59)
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 weeks
Treatment ~ Varies
Follow Up ~screening (day -28) to follow-up (week 59)
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (day -28) to follow-up (week 59) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of subjects achieving HiSCR75
Secondary study objectives
Change in Dermatology Life Quality Index (DLQI)
Incidence of clinically significant change in vital signs
Incidence of clinically significant changes in laboratory values
+9 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
9%
Upper respiratory tract infection
5%
Oropharyngeal pain
5%
Back pain
5%
Injection site pain
4%
Injection site inflammation
4%
Nausea
4%
Influenza
4%
Injection site oedema
4%
Viral upper respiratory tract infection
4%
Urinary tract infection
2%
Diarrhoea
2%
Injection site hypersensitivity
2%
Thermal burn
2%
Epstein-Barr virus infection
2%
Herpes simplex
2%
Postoperative wound infection
2%
Arthralgia
2%
Groin pain
2%
Arthritis
2%
Tonsillitis
2%
Injection site urticaria
2%
Axillary pain
2%
Injection site irritation
2%
Asthenia
2%
Abdominal discomfort
2%
Toothache
2%
Cutaneous vasculitis
2%
Injection site reaction
2%
Injection site bruising
2%
Pyrexia
2%
Eczema
2%
Fall
2%
Fatigue
2%
Injection site discolouration
2%
Erythema nodosum
2%
Tooth disorder
2%
Hot flush
2%
Conjunctivitis allergic
2%
Amenorrhoea
2%
COVID-19
2%
Tinea pedis
2%
Orthostatic hypotension
2%
Gastroenteritis viral
2%
Proteinuria
2%
Gastrointestinal viral infection
2%
Tonsillitis bacterial
2%
Dizziness
2%
Urticaria
2%
Skin papilloma
2%
Muscle spasms
2%
Injection site warmth
2%
Foot fracture
2%
Migraine
2%
Intertrigo
2%
Acute kidney injury
2%
Bradycardia
2%
Autoimmune thyroiditis
2%
SARS-CoV-2 test positive
2%
Dysmenorrhoea
2%
Alanine aminotransferase increased
2%
Tooth fracture
2%
Conjunctival haemorrhage
2%
Joint dislocation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part B Placebo QW/Q2W - Period 1
Part B Izokibep 160 mg QW - Period 1
Part B Izokibep 160 mg Q2W - Period 1
Part A Izokibep 160 mg QW

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
Placebo Group
Group I: Group 2: Izokibep subcutaneous once weeklyExperimental Treatment1 Intervention
Participants will receive izokibep every week to week 51
Group II: Group 1: Placebo subcutaneous once weeklyPlacebo Group2 Interventions
Participants will receive placebo every week to week 15, then izokibep to week 51.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Izokibep
2022
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

ACELYRIN Inc.Lead Sponsor
8 Previous Clinical Trials
849 Total Patients Enrolled
1 Trials studying Hidradenitis Suppurativa
205 Patients Enrolled for Hidradenitis Suppurativa
Donald P. BetahStudy DirectorACELYRIN Inc.
Amol P. Kamboj, MDStudy DirectorACELYRIN Inc.

Media Library

Izokibep (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05905783 — Phase 3
Hidradenitis Suppurativa Research Study Groups: Group 1: Placebo subcutaneous once weekly, Group 2: Izokibep subcutaneous once weekly
Hidradenitis Suppurativa Clinical Trial 2023: Izokibep Highlights & Side Effects. Trial Name: NCT05905783 — Phase 3
Izokibep (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05905783 — Phase 3
~65 spots leftby Jun 2025
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