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Monoclonal Antibodies

Bimekizumab for Hidradenitis Suppurativa (BE HEARD II 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
Pivotal Trial

Summary

This trial will test whether the medication bimekizumab is effective and safe for people with moderate to severe hidradenitis suppurativa.

Eligible Conditions
  • Hidradenitis Suppurativa

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
Secondary study objectives
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
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
113 Previous Clinical Trials
22,640 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,253 Patients Enrolled for Hidradenitis Suppurativa
UCB CaresStudy Director001 844 599 2273
217 Previous Clinical Trials
46,004 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,253 Patients Enrolled for Hidradenitis Suppurativa
~90 spots leftby Nov 2025
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