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Monoclonal Antibodies

Bimekizumab for Psoriasis

Phase 4
Recruiting
Led By Mark Lebwohl, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
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 baseline, week 4, week 8, week 12, week 16
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to test a new medication called bimekizumab for treating moderate-to-severe psoriasis in patients who have not responded well to other treatments. Bimekizumab

Who is the study for?
This trial is for individuals with moderate-to-severe plaque psoriasis who haven't had success with therapies targeting interleukin IL-17A or 23. Participants should have a history of treatment failure and be in need of an alternative.
What is being tested?
The study tests bimekizumab's effectiveness and safety in treating psoriasis. Bimekizumab works by blocking substances called interleukins (IL-17A and IL-17F) to reduce inflammation associated with the condition.
What are the potential side effects?
Potential side effects may include reactions at the injection site, infections due to lowered immune response, headaches, fatigue, and possible gastrointestinal issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, week 12, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8, week 12, week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Surface Area (BSA) of < 1
Secondary study objectives
Physician Global Assessment (PGA) of < 1
Physician Global Assessment (PGA) of < 2
Psoriasis and Severity Index Score (PASI) of < 1
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Individuals with moderate-to-severe psoriasisExperimental Treatment1 Intervention
Individuals with moderate-to-severe psoriasis who have failed similar therapies.
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 PharmaIndustry Sponsor
342 Previous Clinical Trials
109,271 Total Patients Enrolled
Psoriasis Treatment Center of Central New JerseyOTHER
14 Previous Clinical Trials
382 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,708 Total Patients Enrolled
~40 spots leftby Oct 2025
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