A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:January 26, 2018
End Date:March 2020

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of
subjects with moderate to severe chronic plaque psoriasis (PSO).


Inclusion Criteria:

- Must be at least 18 years of age

- Chronic plaque PSO for at least 6 months prior to the Screening Visit

- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
>=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

- Subject is a candidate for systemic PSO therapy and/or phototherapy

- Female subject of child bearing potential must be willing to use highly effective
method of contraception

Exclusion Criteria:

- Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab

- Subject has an active infection (except common cold), a serious infection, or a
history of opportunistic or recurrent chronic infections

- Subject has concurrent acute or chronic viral hepatitis B or C or human
immunodeficiency virus (HIV) infection

- Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

- Subject has any other condition, including medical or psychiatric, which, in the
Investigator's judgment, would make the subject unsuitable for inclusion in the study

- Subject has had previous exposure to adalimumab

- Presence of active suicidal ideation or positive suicide behavior

- Presence of moderately severe major depression or severe major depression

- Subject has any active malignancy or history of malignancy within 5 years prior to the
Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
carcinoma, or in situ cervical cancer
We found this trial at
23
sites
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials
Beverly, Massachusetts 01915
?
mi
from
Beverly, MA
Click here to add this to my saved trials
Boca Raton, Florida 33486
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Brighton, Massachusetts 02135
?
mi
from
Brighton, MA
Click here to add this to my saved trials
Dallas, Texas
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
East Melbourne,
?
mi
from
East Melbourne,
Click here to add this to my saved trials
East Windsor, New Jersey
?
mi
from
East Windsor, NJ
Click here to add this to my saved trials
Glendale, Arizona 85308
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Greer, South Carolina
?
mi
from
Greer, SC
Click here to add this to my saved trials
Houston, Texas
?
mi
from
Houston, TX
Click here to add this to my saved trials
708 South Barrington Avenue
Los Angeles, California 90049
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Overland Park, Kansas 66215
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Portland, Oregon
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rocky Mount, North Carolina 27804
?
mi
from
Rocky Mount, NC
Click here to add this to my saved trials
San Diego, California
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Luis Obispo, California
?
mi
from
San Luis Obispo, CA
Click here to add this to my saved trials
Santa Monica, California
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Tampa, Florida 33624
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Troy, Michigan 48084
?
mi
from
Troy, MI
Click here to add this to my saved trials
West des Moines, Iowa
?
mi
from
West des Moines, IA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27104
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials