← Back to Search

Monoclonal Antibodies

Bermekimab for Hidradenitis Suppurativa (LYRA Trial)

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
Awards & highlights

LYRA Trial Summary

This trial will test whether bermekimab can improve the symptoms of Hidradenitis Suppurativa.

Eligible Conditions
  • Hidradenitis Suppurativa

LYRA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16
Secondary outcome measures
Number of Participants With Antibodies to Bermekimab
Part 1: Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16
Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16
+8 more

LYRA Trial Design

7Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part 2 (Group 4): Bermekimab Dose 2Experimental Treatment2 Interventions
Participants will receive bermekimab dose 2 SC and placebo SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 2 SC and placebo SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.
Group II: Part 2 (Group 3): Bermekimab Dose 1Experimental Treatment2 Interventions
Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 1 SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.
Group III: Part 2 (Group 2): Bermekimab Dose 1Experimental Treatment1 Intervention
Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.
Group IV: Part 1 (Group 3): Bermekimab Dose 1Experimental Treatment2 Interventions
Participants will receive bermekimab dose 1 SC and placebo SC at Week 0, followed by bermekimab dose 1 SC at Week 1 and every week thereafter through Week 31.
Group V: Part 1 (Group 2): AdalimumabActive Control2 Interventions
Participants will receive adalimumab 160 milligrams (mg) SC at Week 0, placebo SC at Week 1, followed by adalimumab 80 mg SC and placebo SC at Weeks 2 and 3. Participants will then receive adalimumab 40 mg SC and placebo SC at Week 4 and every week thereafter through Week 31.
Group VI: Part 2 (Group 1): PlaceboPlacebo Group2 Interventions
Participants will receive placebo SC from Week 0 through Week 11. At Week 12, participants will cross over to receive bermekimab dose 1 SC weekly through Week 31.
Group VII: Part 1 (Group 1): PlaceboPlacebo Group2 Interventions
Participants will receive placebo subcutaneously (SC) at Week 0 through Week 15. At Week 16, participants will cross over to receive bermekimab dose 1 SC every week thereafter through Week 31.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,157 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
379 Patients Enrolled for Hidradenitis Suppurativa
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,754 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
379 Patients Enrolled for Hidradenitis Suppurativa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are the most that can enroll in this trial?

"Janssen Research & Development, LLC needs to recruit 300 eligible patients from different clinical sites in order to run the trial. Some of these locations include Beth Israel Deaconess Medical Center in Boston, Massachusetts and Clinical Partners in Johnston, Rhode island."

Answered by AI

Is this trial available in many locations within the city?

"This clinical trial is accepting patients at 29 locations, including Beth Israel Deaconess Medical Center in Boston, Massachusetts; Clinical Partners in Johnston, Rhode island; and Renstar Medical Research in Ocala, Florida."

Answered by AI

Does Bermekimab put patients at risk?

"While Phase 2 trials are not as reliable in terms of efficacy, the data collected thus far suggests that Bermekimab is safe. Therefore, it receives a safety score of 2."

Answered by AI

How is Bermekimab most often employed?

"Bermekimab is frequently used to ameliorate ankylosing spondylitis. This medication can also be helpful for patients with rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis."

Answered by AI

What is the objective of this research project?

"According to the trial sponsor, Janssen Research & Development, LLC, the primary outcome of this study will be Part 2: Percentage of Participants Achieving Hidradenitis suppurativa Clinical Response-50 (HiSCR50), which will be measured over a Week 16 interval. Additionally, this study will assess secondary outcomes including Parts 1 and 2: Change from Baseline in Number of Inflammatory Nodules (defined as change from baseline in number of inflammatory nodules reported) , Parts 1 and 2: Change from Baseline in Dermatology Life Quality Index (DLQI) Score( defined"

Answered by AI

Are you looking for more people to join this research project?

"The clinical trial is recruiting patients, as of 10/25/2022. The posted was first created on 10/12/2021."

Answered by AI

Is this the first time that Bermekimab has been studied?

"University of Nebraska Medical Center first studied bermekimab in 2007. Since that time, 18539 studies have been completed with 52 active trials at the moment. A considerable amount of these ongoing trials are based in Boston, Massachusetts."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Progressive Clinical Research
Center for Clinical Studies
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa
2021. "A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04988308.
~43 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top