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Interleukin 17A Inhibitor
Izokibep for Hidradenitis Suppurativa
Phase 2
Waitlist Available
Research Sponsored by ACELYRIN Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas , one of which is Hurley Stage II or III.
18 years to 75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: day 1, weeks 4, 8, 12, 16, 24, 32 and at follow-up (weeks 39 and 45)
Awards & highlights
Study Summary
This trial is testing a new drug to treat hidradenitis suppurativa, a painful skin condition. The drug is given as a shot, and the trial will test how well it works and if it has any side effects.
Who is the study for?
Adults aged 18-75 with moderate to severe Hidradenitis Suppurativa (HS), having lesions in at least two areas, one being Hurley Stage II or III. Participants must have had HS for over a year, not responded well to oral antibiotics, and be willing to use daily antiseptics and keep a pain diary.Check my eligibility
What is being tested?
The trial is testing Izokibep, an inhibitor targeting interleukin 17A (IL-17A) against a placebo. It aims to assess the drug's effectiveness and safety when injected under the skin in those with HS who haven't seen improvement from standard treatments.See study design
What are the potential side effects?
While specific side effects of Izokibep are not listed here, inhibitors like it can potentially cause injection site reactions, increased risk of infections due to immune system suppression, allergic reactions, or other immune-related conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have skin lesions in 2 different areas, with at least one being moderate to severe.
Select...
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 cleaning products.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part b: day 1, weeks 4, 8, 12, 16, 24, 32 and at follow-up (weeks 39 and 45)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part b: day 1, weeks 4, 8, 12, 16, 24, 32 and at follow-up (weeks 39 and 45)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Hidradenitis suppurativa clinical response (HiSCR75)
Part B: Hidradenitis suppurativa clinical response (HiSCR75)
Secondary outcome measures
Part A: Incidence of clinically significant changes in laboratory values
Part A: Incidence of clinically significant changes in vital signs
Part A: Incidence of serious adverse events (SAEs)
+14 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B (Double-blind) izokibep every weekExperimental Treatment1 Intervention
Participants will receive izokibep weekly for 31 weeks.
Group II: Part B (Double-blind) izokibep every other weekExperimental Treatment1 Intervention
Participants will receive izokibep every other week for 30 weeks.
Group III: Part A (Open-label) izokibep every weekExperimental Treatment1 Intervention
Participants will receive izokibep every week from Day 1 through Week 31
Group IV: Part B (Double-blind) placebo every other weekPlacebo Group1 Intervention
Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.
Group V: Part B (Double-blind) placebo every weekPlacebo Group1 Intervention
Participants will receive placebo weekly up to Week 15, then izokibep from Week 16 to Week 31.
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
882 Total Patients Enrolled
1 Trials studying Hidradenitis Suppurativa
250 Patients Enrolled for Hidradenitis Suppurativa
Paul M Peloso, MD, MSc.Study DirectorACELYRIN Inc.
1 Previous Clinical Trials
100 Total Patients Enrolled
Donald Betah, MDStudy DirectorACELYRIN Inc.
1 Previous Clinical Trials
7 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had outpatient surgery within the last 8 weeks or inpatient surgery within the last 12 weeks.I have been diagnosed with HIV.I have been diagnosed with hidradenitis suppurativa for at least 1 year.I do not have active tuberculosis or fungal infection, or it has been treated and resolved.I do not have any skin conditions that could affect the study.I do not have an active infection or a history of serious infections.I am willing to keep a daily diary of my skin pain.I have skin lesions in 2 different areas, with at least one being moderate to severe.You have provided informed consent to comply with the requirements and restrictions listed in the ICF and in this protocol.It seems like this criterion is not specific. Could you please provide more details or context so that I can assist you accurately?I have been diagnosed with hidradenitis suppurativa for at least 1 year.I do not have any uncontrolled serious illnesses.I have chronic pain not related to my skin condition.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.My condition matches the specific type and characteristics required.I was diagnosed with cancer within the last 5 years.You have three or more abscesses and inflammatory nodules at the screening and enrollment.You have more than 20 draining fistulas.You have five or more abscesses or inflammatory nodules at the time of screening and before starting the study.I have a history of diseases that affect the protective covering of nerves.I agree to use daily skin cleaning products.You are in danger of hurting yourself or others.My skin condition didn't improve with oral antibiotics, or it came back after stopping them, or I can't take them due to side effects or other reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Part B (Double-blind) izokibep every other week
- Group 2: Part B (Double-blind) placebo every other week
- Group 3: Part B (Double-blind) izokibep every week
- Group 4: Part A (Open-label) izokibep every week
- Group 5: Part B (Double-blind) placebo every week
Awards:
This trial has 0 awards, including: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.
Hidradenitis Suppurativa Patient Testimony for trial: Trial Name: NCT05355805 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to become a participant in this clinical trial?
"This clinical trial is recruiting 180 participants between ages of 18 and 75 who have been clinically diagnosed with hidradenitis suppurativa. To be eligible, individuals must meet the following criteria: Of legal age; having had HS for a minimum of 1 year prior to the commencement of treatment; lesions present in at least two distinct anatomical regions (Hurley Stage II or III); an abscess and inflammatory nodule count greater than 3 at screening/Day 1; inadequate response to oral antibiotics either due to recurrence upon discontinuation or intolerance/contraindication thereof; agreement to use daily topical antiseptics; readiness to complete a"
Answered by AI
Are minors included in the selection criteria for this trial?
"The clinical trial is open to those aged 18-75, with 3 sub studies for minors and 35 additional spaces reserved for participants older than 65."
Answered by AI
Are there any open spots available to join this experiment?
"The information hosted on clinicaltrials.gov reveals that recruitment for this medical trial is in progress, having been initiated on the 5th of May 2022 and most recently updated on November 21st 2022."
Answered by AI
Has the FDA approved Izokibep for general use?
"Izokibep's safety is speculated to be a 2, as the data collected thus far has only established its potential for harmlessness but not efficacy."
Answered by AI
What is the volume of participants engaging in this medical experiment?
"Affirmative. According to clinicaltrials.gov, this study is actively recruiting as of November 21st 2022 and has been since May 5th 2020. 180 volunteers need to be recruited from 23 sites in total."
Answered by AI
How many venues are associated with this clinical investigation?
"This clinical trial is now being conducted in 23 distinct sites. These range from Lebanon, London and Murray to 20 other locales. For the convenience of participants, it's important to choose a site which is nearest your residence so as to reduce travel time requirements."
Answered by AI
Who else is applying?
What state do they live in?
Washington
Nevada
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
Clinical Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What questions have other patients asked about this trial?
Will u provide transportation?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I just want the pain to stop. I just want to see what's new out there for treatment of this horrible disease.
PatientReceived 2+ prior treatments
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