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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (day -28) to follow-up (week 59)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 75 years old.
Select...
I have skin lesions in 2 different areas, with at least one area being moderate to severe.
Select...
I agree to use daily skin antiseptics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening (day -28) to follow-up (week 59)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (day -28) to follow-up (week 59)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of subjects achieving HiSCR75
Secondary outcome measures
Change in Dermatology Life Quality Index (DLQI)
Incidence of clinically significant change in vital signs
Incidence of clinically significant changes in laboratory values
+9 moreTrial 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
~190
Find a Location
Who is running the clinical trial?
ACELYRIN Inc.Lead Sponsor
8 Previous Clinical Trials
808 Total Patients Enrolled
1 Trials studying Hidradenitis Suppurativa
176 Patients Enrolled for Hidradenitis Suppurativa
Donald P. BetahStudy DirectorACELYRIN Inc.
Amol P. Kamboj, MDStudy DirectorACELYRIN Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.I have been diagnosed with HS for at least 6 months.I do not have any skin conditions that could affect the study.I have been diagnosed with HIV.I had outpatient surgery within the last 8 weeks or inpatient surgery within the last 12 weeks.I agree to use daily skin antiseptics.I have a serious illness that is not under control.I have a history of diseases that affect the protective covering of nerves.The person poses a risk of hurting themselves or someone else.I have had symptoms or a diagnosis of inflammatory bowel disease in the past year.I do not have an active infection or a history of serious infections.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Placebo subcutaneous once weekly
- Group 2: Group 2: Izokibep subcutaneous once weekly
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is this trial open for participation?
"Individuals with hidradenitis suppurativa aged between 18 and 75 can apply for this medical trial. Approximately 250 volunteers are being sought after."
Answered by AI
Is this research endeavor currently recruiting participants?
"Details on clinicaltrials.gov suggest that this medical investigation is presently enrolling patients, having initially been posted on June 1st 2023 and last updated a week later."
Answered by AI
Does this research initiative permit volunteers aged 20 or older?
"The eligibility requirements for this study necessitate that participants are between 18 to 75 years old. There are 4 specialised trials designed specifically for those below the age of consent and 35 aimed at senior citizens."
Answered by AI
Has the FDA sanctioned Group 2: Izokibep subcutaneous administration on a weekly basis?
"Data collected from the Phase 3 clinical trial suggests that there is a degree of efficacy and safety for Group 2: Izokibep subcutaneous administered on a weekly basis, which earns it a score of 3."
Answered by AI
How many participants have taken part in the research thus far?
"Affirmative. The data posted to clinicaltrials.gov indicates that this medical study, initially made available on June 1st 2023, is still actively enlisting participants. A total of 250 individuals are required from one site for the trial's completion."
Answered by AI
Who else is applying?
What site did they apply to?
Other
Clinical Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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