Your session is about to expire
← Back to Search
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
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
BE HEARD EXT Trial Summary
This trial will test the safety of bimekizumab, a medication used to treat hidradenitis suppurativa (HS), in study participants with moderate to severe HS.
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.Check my eligibility
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.See study design
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.
BE HEARD EXT Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Secondary outcome measures
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 moreBE HEARD EXT 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
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
20,778 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,104 Patients Enrolled for Hidradenitis Suppurativa
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,305 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project pave the way for other similar investigations?
"Research on bimekizumab began in 2018 with the first clinical trial sponsored by UCB Biopharma SRL. This initial study involved 743 patients. Based on the data collected, bimekizumab received approval for Phase 3 clinical trials. There are currently 8 active studies taking place in 120 cities and 26 countries."
Answered by AI
How many research sites are conducting this trial?
"The trial's 54 sites are located in Hs0005 50136 (Winnipeg, California), Hs0005 50134 (Waterloo, Massachusetts), Hs0005 50192 (Saskatoon, Kentucky), as well as 51 others."
Answered by AI
To what extent has Bimekizumab been studied in the past?
"There are 8 Bimekizumab trials currently underway, 7 of which are in Phase 3. Many of these studies are being conducted in Phillip, Oregon, but there are 1025 research sites total for this medication."
Answered by AI
Are there any patients enrolled in this research yet?
"This specific clinical trial is not currently looking for patients, as the last update was on October 20th, 2022. However, there are 37 other trials for hidradenitis suppurativa and 8 trials for Bimekizumab that are actively seeking patients."
Answered by AI
What are some of the potential risks associated with Bimekizumab?
"Bimekizumab was given a score of 3 because there is evidence from Phase 3 trials that it is effective and multiple rounds of trials have shown that it is safe."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
Tennessee
South Carolina
Other
How old are they?
18 - 65
What site did they apply to?
Hs0005 50146
Hs0005 50084
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I need help managing my HS. I've struggled with HS for years. Antibiotics are no help, nor has any other medication..
PatientReceived 1 prior treatment
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger