Bimekizumab for Psoriasis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Psoriasis+2 More
Bimekizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the long-term effects of a medication called bimekizumab on adults with moderate to severe plaque psoriasis.

Eligible Conditions
  • Psoriasis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: From Baseline to Safety Follow Up 2 (up to Week 220)

Week 220
Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP
Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP
Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP)
Week 144
Investigator´s Global Assessment (IGA) 0/1 response at Week 144
Psoriasis Area Severity Index 90 (PASI90) response at Week 144

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ustekinumab Initial Period (SS)
9%Nasopharyngitis
4%Headache
3%Hypertension
3%Upper respiratory tract infection
2%Back pain
1%Intervertebral disc protrusion
1%Urinary tract infection
1%Cardiac arrest
1%Macular hole
1%Wound infection
1%Heart injury
1%Brain injury
1%Psoriasis
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03370133) in the Ustekinumab Initial Period (SS) ARM group. Side effects include: Nasopharyngitis with 9%, Headache with 4%, Hypertension with 3%, Upper respiratory tract infection with 3%, Back pain with 2%.

Trial Design

2 Treatment Groups

Bimekizumab dose regimen 1
1 of 2
Bimekizumab dose regimen 2
1 of 2

Experimental Treatment

1355 Total Participants · 2 Treatment Groups

Primary Treatment: Bimekizumab · No Placebo Group · Phase 3

Bimekizumab dose regimen 1
Drug
Experimental Group · 1 Intervention: Bimekizumab · Intervention Types: Drug
Bimekizumab dose regimen 2
Drug
Experimental Group · 1 Intervention: Bimekizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimekizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to safety follow up 2 (up to week 220)

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
83 Previous Clinical Trials
19,329 Total Patients Enrolled
11 Trials studying Psoriasis
3,182 Patients Enrolled for Psoriasis
UCB CaresStudy Director001 844 599 2273
186 Previous Clinical Trials
42,115 Total Patients Enrolled
19 Trials studying Psoriasis
4,844 Patients Enrolled for Psoriasis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Treatment period is at least 12 weeks.
You are female and of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
65+100.0%
What site did they apply to?
Ps0014 913100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%