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Monoclonal Antibodies
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe 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
Pivotal Trial
Summary
This trial is testing a medication called bimekizumab to see if it is safe and effective for people with moderate to severe hidradenitis suppurativa. Hidradenitis suppurativa is a painful skin condition that causes lumps under the skin. Bimekizumab works by blocking certain proteins that cause inflammation, helping to reduce pain and swelling.
Eligible Conditions
- Hidradenitis Suppurativa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (day 1) until safety follow-up (up to week 71)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) until safety follow-up (up to week 71)
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
+4 moreAwards & 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
~6500
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
115 Previous Clinical Trials
22,694 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,257 Patients Enrolled for Hidradenitis Suppurativa
UCB CaresStudy Director001 844 599 2273
219 Previous Clinical Trials
46,068 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
1,257 Patients Enrolled for Hidradenitis Suppurativa