A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

Study Purpose

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female patients at least 18 years of age.
  • - Subject has ankylosing spondylitis (AS) as per the Modified New York (mNY) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years.
  • - Subjects has moderate-to-severe active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale.
  • - Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy.
  • - Patients who have taken a tumor necrosis factor alpha (TNFα) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks.
  • - Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry.

Exclusion Criteria:

  • - Total ankylosis of the spine.
  • - Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα biological response modifiers, or any interleukin (IL)-17 biological response modifier at any time are excluded.
  • - Active infection or history of recent serious infections.
  • - Viral hepatitis B or C or human immunodeficiency virus (HIV) infection.
  • - Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study.
  • - Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection.
  • - 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.
  • - Diagnosis of inflammatory conditions other than AxSpA, eg, rheumatoid arthritis.
Patients with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study.
  • - Presence of active suicidal ideation, or moderately severe major depression or severe major depression.
  • - Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study.
- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03928743
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UCB Biopharma SRL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Bulgaria, China, Czechia, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ankylosing Spondylitis
Arms & Interventions

Arms

Experimental: Bimekizumab

Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.

Placebo Comparator: Placebo

Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.

Interventions

Drug: - Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

Other: - Placebo

Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

As0011 50052, Phoenix, Arizona

Status

Recruiting

Address

As0011 50052

Phoenix, Arizona, 85032

As0011 50058, Phoenix, Arizona

Status

Recruiting

Address

As0011 50058

Phoenix, Arizona, 85037

As0011 50062, Sun City, Arizona

Status

Recruiting

Address

As0011 50062

Sun City, Arizona, 85351

As0011 50131, Sun City, Arizona

Status

Recruiting

Address

As0011 50131

Sun City, Arizona, 85351

As0011 50060, Upland, California

Status

Recruiting

Address

As0011 50060

Upland, California, 91786

As0011 50056, Sarasota, Florida

Status

Recruiting

Address

As0011 50056

Sarasota, Florida, 34239

As0011 50015, Hagerstown, Maryland

Status

Recruiting

Address

As0011 50015

Hagerstown, Maryland, 21742

As0011 50016, Saint Louis, Missouri

Status

Recruiting

Address

As0011 50016

Saint Louis, Missouri, 63141

As0011 50116, Cleveland, Ohio

Status

Recruiting

Address

As0011 50116

Cleveland, Ohio, 44109-1998

As0011 50054, Oklahoma City, Oklahoma

Status

Recruiting

Address

As0011 50054

Oklahoma City, Oklahoma, 73103

As0011 50020, Duncansville, Pennsylvania

Status

Recruiting

Address

As0011 50020

Duncansville, Pennsylvania, 16635

As0011 50001, Jackson, Tennessee

Status

Recruiting

Address

As0011 50001

Jackson, Tennessee, 38305

As0011 50012, Memphis, Tennessee

Status

Recruiting

Address

As0011 50012

Memphis, Tennessee, 38119

As0011 50053, Austin, Texas

Status

Recruiting

Address

As0011 50053

Austin, Texas, 78731

As0011 50057, Dallas, Texas

Status

Recruiting

Address

As0011 50057

Dallas, Texas, 75231

As0011 50036, Mesquite, Texas

Status

Recruiting

Address

As0011 50036

Mesquite, Texas, 75150

As0011 50027, Seattle, Washington

Status

Suspended

Address

As0011 50027

Seattle, Washington, 98122

International Sites

As0011 40004, Brussels, Belgium

Status

Completed

Address

As0011 40004

Brussels, ,

As0011 40002, Genk, Belgium

Status

Recruiting

Address

As0011 40002

Genk, ,

As0011 40003, Genk, Belgium

Status

Active, not recruiting

Address

As0011 40003

Genk, ,

As0011 40001, Gent, Belgium

Status

Completed

Address

As0011 40001

Gent, ,

As0011 40006, Plovdiv, Bulgaria

Status

Completed

Address

As0011 40006

Plovdiv, ,

As0011 40007, Plovdiv, Bulgaria

Status

Completed

Address

As0011 40007

Plovdiv, ,

As0011 40005, Sofia, Bulgaria

Status

Completed

Address

As0011 40005

Sofia, ,

As0011 40008, Sofia, Bulgaria

Status

Active, not recruiting

Address

As0011 40008

Sofia, ,

As0011 20040, Beijing, China

Status

Recruiting

Address

As0011 20040

Beijing, ,

As0011 20021, Chengdu, China

Status

Recruiting

Address

As0011 20021

Chengdu, ,

As0011 20019, Guangzhou, China

Status

Recruiting

Address

As0011 20019

Guangzhou, ,

As0011 20034, Hefei SHI, China

Status

Recruiting

Address

As0011 20034

Hefei SHI, ,

As0011 20024, Nanjing, China

Status

Recruiting

Address

As0011 20024

Nanjing, ,

As0011 20018, Shanghai, China

Status

Recruiting

Address

As0011 20018

Shanghai, ,

As0011 20020, Shanghai, China

Status

Recruiting

Address

As0011 20020

Shanghai, ,

As0011 20026, Shanghai, China

Status

Recruiting

Address

As0011 20026

Shanghai, ,

As0011 20025, Wenzhou, China

Status

Recruiting

Address

As0011 20025

Wenzhou, ,

As0011 40011, Brno, Czechia

Status

Completed

Address

As0011 40011

Brno, ,

As0011 40009, Pardubice, Czechia

Status

Completed

Address

As0011 40009

Pardubice, ,

As0011 40013, Praha 11, Czechia

Status

Completed

Address

As0011 40013

Praha 11, ,

As0011 40016, Praha 2, Czechia

Status

Completed

Address

As0011 40016

Praha 2, ,

As0011 40015, Praha 3, Czechia

Status

Active, not recruiting

Address

As0011 40015

Praha 3, ,

As0011 40014, Praha 4, Czechia

Status

Active, not recruiting

Address

As0011 40014

Praha 4, ,

As0011 40010, Uherské Hradiště, Czechia

Status

Active, not recruiting

Address

As0011 40010

Uherské Hradiště, ,

As0011 40012, Zlín, Czechia

Status

Completed

Address

As0011 40012

Zlín, ,

As0011 40018, Boulogne-Billancourt, France

Status

Active, not recruiting

Address

As0011 40018

Boulogne-Billancourt, ,

As0011 40022, Limoges, France

Status

Recruiting

Address

As0011 40022

Limoges, ,

As0011 40021, Orléans, France

Status

Recruiting

Address

As0011 40021

Orléans, ,

As0011 40025, Berlin, Germany

Status

Active, not recruiting

Address

As0011 40025

Berlin, ,

As0011 40028, Berlin, Germany

Status

Completed

Address

As0011 40028

Berlin, ,

As0011 40029, Hamburg, Germany

Status

Active, not recruiting

Address

As0011 40029

Hamburg, ,

As0011 40024, Hannover, Germany

Status

Active, not recruiting

Address

As0011 40024

Hannover, ,

As0011 40027, Herne, Germany

Status

Active, not recruiting

Address

As0011 40027

Herne, ,

As0011 40078, Leipzig, Germany

Status

Recruiting

Address

As0011 40078

Leipzig, ,

As0011 40026, Ratingen, Germany

Status

Active, not recruiting

Address

As0011 40026

Ratingen, ,

As0011 40032, Debrecen, Hungary

Status

Completed

Address

As0011 40032

Debrecen, ,

As0011 40031, Szeged, Hungary

Status

Completed

Address

As0011 40031

Szeged, ,

As0011 40080, Szombathely, Hungary

Status

Completed

Address

As0011 40080

Szombathely, ,

As0011 40033, Székesfehérvár, Hungary

Status

Completed

Address

As0011 40033

Székesfehérvár, ,

As0011 20047, Himeji, Japan

Status

Recruiting

Address

As0011 20047

Himeji, ,

As0011 20039, Iruma-Gun, Japan

Status

Recruiting

Address

As0011 20039

Iruma-Gun, ,

As0011 20036, Kawachi-Nagano, Japan

Status

Recruiting

Address

As0011 20036

Kawachi-Nagano, ,

As0011 20065, Kitakyushu, Japan

Status

Recruiting

Address

As0011 20065

Kitakyushu, ,

As0011 20045, Kita, Japan

Status

Recruiting

Address

As0011 20045

Kita, ,

As0011 20038, Nankoku, Japan

Status

Recruiting

Address

As0011 20038

Nankoku, ,

As0011 20037, Osaka, Japan

Status

Recruiting

Address

As0011 20037

Osaka, ,

As0011 20084, Saga, Japan

Status

Recruiting

Address

As0011 20084

Saga, ,

As0011 20048, Saitama, Japan

Status

Recruiting

Address

As0011 20048

Saitama, ,

As0011 20031, Sapporo-City, Japan

Status

Recruiting

Address

As0011 20031

Sapporo-City, ,

As0011 20042, Sasebo, Japan

Status

Suspended

Address

As0011 20042

Sasebo, ,

As0011 20032, Suita, Japan

Status

Recruiting

Address

As0011 20032

Suita, ,

As0011 20030, Tokyo, Japan

Status

Recruiting

Address

As0011 20030

Tokyo, ,

As0011 20035, Tokyo, Japan

Status

Recruiting

Address

As0011 20035

Tokyo, ,

As0011 40034, Amsterdam, Netherlands

Status

Suspended

Address

As0011 40034

Amsterdam, ,

As0011 40035, Rotterdam, Netherlands

Status

Recruiting

Address

As0011 40035

Rotterdam, ,

As0011 40038, Elbląg, Poland

Status

Completed

Address

As0011 40038

Elbląg, ,

As0011 40042, Kraków, Poland

Status

Recruiting

Address

As0011 40042

Kraków, ,

As0011 40037, Lublin, Poland

Status

Completed

Address

As0011 40037

Lublin, ,

As0011 40044, Poznań, Poland

Status

Completed

Address

As0011 40044

Poznań, ,

As0011 40040, Toruń, Poland

Status

Completed

Address

As0011 40040

Toruń, ,

As0011 40041, Warsaw, Poland

Status

Recruiting

Address

As0011 40041

Warsaw, ,

As0011 40039, Wrocław, Poland

Status

Completed

Address

As0011 40039

Wrocław, ,

As0011 40043, Wrocław, Poland

Status

Completed

Address

As0011 40043

Wrocław, ,

As0011 40045, Coruña, Spain

Status

Recruiting

Address

As0011 40045

Coruña, ,

As0011 40046, Córdoba, Spain

Status

Active, not recruiting

Address

As0011 40046

Córdoba, ,

As0011 40047, Madrid, Spain

Status

Active, not recruiting

Address

As0011 40047

Madrid, ,

As0011 40048, Santiago De Compostela, Spain

Status

Active, not recruiting

Address

As0011 40048

Santiago De Compostela, ,

As0011 40049, Sevilla, Spain

Status

Active, not recruiting

Address

As0011 40049

Sevilla, ,

As0011 40052, Ankara, Turkey

Status

Active, not recruiting

Address

As0011 40052

Ankara, ,

As0011 40053, Ankara, Turkey

Status

Recruiting

Address

As0011 40053

Ankara, ,

As0011 40050, Istanbul, Turkey

Status

Active, not recruiting

Address

As0011 40050

Istanbul, ,

As0011 40051, İzmir, Turkey

Status

Recruiting

Address

As0011 40051

İzmir, ,

As0011 40057, Edinburgh, United Kingdom

Status

Recruiting

Address

As0011 40057

Edinburgh, ,

As0011 40056, Leeds, United Kingdom

Status

Recruiting

Address

As0011 40056

Leeds, ,

As0011 40054, London, United Kingdom

Status

Suspended

Address

As0011 40054

London, ,

As0011 40055, Norwich, United Kingdom

Status

Recruiting

Address

As0011 40055

Norwich, ,