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Monoclonal Antibodies
Bimekizumab for Hidradenitis Suppurativa (BE HEARD EXT Trial)
Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 16, week 32, week 48, week 76, week 92, week 100, week 116, week 132, week 148, week 164, and week 180
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing the safety of bimekizumab, a medication for people with moderate to severe hidradenitis suppurativa (HS). Bimekizumab aims to reduce inflammation and alleviate symptoms by targeting certain proteins in the body.
Who is the study for?
This trial is for individuals with moderate to severe hidradenitis suppurativa who have completed a previous study (HS0003 or HS0004) without withdrawal. Participants must not be pregnant, breastfeeding, and women of childbearing potential must agree to follow contraceptive guidance.
What is being tested?
The trial is testing the long-term safety of Bimekizumab in treating moderate to severe hidradenitis suppurativa. It's an extension study for those who've already been on Bimekizumab during earlier trials.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to the long-term use of Bimekizumab as part of their treatment regimen.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, nor planning to become pregnant soon.
Select...
I am not using any forbidden treatments for my skin condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0, week 16, week 32, week 48, week 76, week 92, week 100, week 116, week 132, week 148, week 164, and week 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 16, week 32, week 48, week 76, week 92, week 100, week 116, week 132, week 148, week 164, and week 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Secondary study objectives
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
+4 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Bimekizumab dosing regimen 2Experimental Treatment1 Intervention
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
Group II: Bimekizumab dosing regimen 1Experimental Treatment1 Intervention
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimekizumab
2018
Completed Phase 3
~6510
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules and abscesses. Common treatments for HS often target specific components of the immune system to reduce inflammation.
Bimekizumab, for example, inhibits interleukin-17A (IL-17A) and interleukin-17F (IL-17F), which are cytokines involved in the inflammatory response. By blocking these cytokines, Bimekizumab can reduce the inflammation and immune response that contribute to the symptoms of HS.
This mechanism is crucial for HS patients as it directly addresses the underlying inflammation, potentially leading to reduced pain, fewer flare-ups, and improved quality of life.
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
112 Previous Clinical Trials
22,451 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,104 Patients Enrolled for Hidradenitis Suppurativa
UCB CaresStudy Director001 844 599 2273
215 Previous Clinical Trials
45,793 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,104 Patients Enrolled for Hidradenitis Suppurativa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A study participant is considered to be reliable and capable of adhering to the protocol (e.g., able to understand and complete questionnaires), visit schedule, and medication intake, according to the judgement of the InvestigatorI am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines.I have a positive or unclear TB test but have been checked or treated.I can follow the study's schedule and take medications as directed.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I am not using any forbidden treatments for my skin condition.I finished a 48-week treatment in either HS0003 or HS0004 study without disqualifying conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Bimekizumab dosing regimen 2
- Group 2: Bimekizumab dosing regimen 1
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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: NCT04901195 — Phase 3
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