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Monoclonal Antibodies

Bimekizumab for Hidradenitis Suppurativa (BE HEARD I 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 from baseline (day 1) until safety follow-up (up to week 71)
Awards & highlights

BE HEARD I Trial Summary

This trial will test whether the drug bimekizumab is effective and safe for treating moderate to severe hidradenitis suppurativa.

Eligible Conditions
  • Hidradenitis Suppurativa

BE HEARD I Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) until safety follow-up (up to week 71)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) until safety follow-up (up to week 71) for reporting.

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 achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
Secondary outcome measures
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Absolute change from Baseline in Skin Pain score at Week 16
Percentage of participants achieving Skin Pain response at Week 16
+4 more

BE HEARD I Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Bimekizumab dosing regimen 3Experimental Treatment1 Intervention
Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.
Group II: Bimekizumab dosing regimen 2Experimental Treatment1 Intervention
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.
Group III: Bimekizumab dosing regimen 1Experimental Treatment1 Intervention
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.
Group IV: Placebo GroupPlacebo Group2 Interventions
Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment 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
102 Previous Clinical Trials
21,099 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,257 Patients Enrolled for Hidradenitis Suppurativa
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,459 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,257 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.

Does this experiment represent a new development in medical research?

"Bimekizumab has been under medical scrutiny since 2018 when it was first trialled by UCB Biopharma SRL. After the initial study of 743 people, the Phase 3 drug approval was given in 2018. There are 8 ongoing trials in 120 cities and 26 countries."

Answered by AI

Is this clinical trial taking place in numerous medical facilities across the state?

"This study is recruiting patients from 38 different sites across the United States. Some of the locations include St. John's, Saint John's and Indianapolis. If you are interested in enrolling in the study, it is helpful to choose a location that is close to you to minimize travel requirements."

Answered by AI

Has Bimekizumab been tested in any other human studies?

"Bimekizumab was first studied in 2018 under the identifier Ps0015 372. There have been a total of 18273 completed studies since then. Right now, there are 8 active trials taking place, a large number of which are located in St. John's, Indiana."

Answered by AI

Are investigators still looking for study participants?

"This particular trial is not enrolling new patients at the moment. The trial was first posted on February 19th, 2020 and updated October 27th, 2022. There are currently 38 other trials recruiting patients with hidradenitis suppurativa and 8 for Bimekizumab."

Answered by AI

Has Bimekizumab been accepted by the FDA?

"There is supporting clinical evidence for the efficacy of Bimekizumab, thus it received a score of 3 for safety."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Tennessee
How old are they?
18 - 65
What site did they apply to?
Hs0003 50280
Hs0003 50137
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
2020. "A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04242446.
~98 spots leftby May 2025
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