A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

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 nonradiographic axial spondyloarthritis (nr-axSpA).

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.
  • - Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria: 1.
Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria. 2. Inflammatory back pain for at least 3 months. 3. Age at symptom onset of less than 45 years. 4. NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray)
  • - Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale.
  • - Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein.
  • - 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:

  • - 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.
  • - 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 axial spondyloarthritis (axSpA), including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive 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.

NCT03928704
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.

Nonradiographic Axial Spondyloarthritis
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.

As0010 50052, Phoenix, Arizona

Status

Recruiting

Address

As0010 50052

Phoenix, Arizona, 85037

As0010 50058, Phoenix, Arizona

Status

Recruiting

Address

As0010 50058

Phoenix, Arizona, 85037

As0010 50131, Phoenix, Arizona

Status

Recruiting

Address

As0010 50131

Phoenix, Arizona, 85037

As0010 50062, Sun City, Arizona

Status

Recruiting

Address

As0010 50062

Sun City, Arizona, 85351

As0010 50060, Upland, California

Status

Recruiting

Address

As0010 50060

Upland, California, 91786

As0010 50059, Ormond Beach, Florida

Status

Recruiting

Address

As0010 50059

Ormond Beach, Florida, 32174

As0010 50056, Sarasota, Florida

Status

Recruiting

Address

As0010 50056

Sarasota, Florida, 34239

As0010 50015, Hagerstown, Maryland

Status

Recruiting

Address

As0010 50015

Hagerstown, Maryland, 21742

As0010 50016, Saint Louis, Missouri

Status

Recruiting

Address

As0010 50016

Saint Louis, Missouri, 63141

As0010 50116, Cleveland, Ohio

Status

Recruiting

Address

As0010 50116

Cleveland, Ohio, 44109-19 98

As0010 50054, Oklahoma City, Oklahoma

Status

Recruiting

Address

As0010 50054

Oklahoma City, Oklahoma, 73103

As0010 50055, Portland, Oregon

Status

Recruiting

Address

As0010 50055

Portland, Oregon, 97239

As0010 50020, Duncansville, Pennsylvania

Status

Recruiting

Address

As0010 50020

Duncansville, Pennsylvania, 16635

As0010 50001, Jacksonville, Tennessee

Status

Recruiting

Address

As0010 50001

Jacksonville, Tennessee, 38305

As0010 50012, Memphis, Tennessee

Status

Recruiting

Address

As0010 50012

Memphis, Tennessee, 38119

As0010 50053, Austin, Texas

Status

Completed

Address

As0010 50053

Austin, Texas, 78741

As0010 50057, Dallas, Texas

Status

Recruiting

Address

As0010 50057

Dallas, Texas, 75231

As0010 50036, Mesquite, Texas

Status

Recruiting

Address

As0010 50036

Mesquite, Texas, 75150

As0010 50027, Seattle, Washington

Status

Suspended

Address

As0010 50027

Seattle, Washington, 98122

As0010 50061, Spokane, Washington

Status

Recruiting

Address

As0010 50061

Spokane, Washington, 99204

International Sites

As001 40004, Brussels, Belgium

Status

Recruiting

Address

As001 40004

Brussels, ,

As001 40003, Genk, Belgium

Status

Recruiting

Address

As001 40003

Genk, ,

As0010 40001, Gent, Belgium

Status

Recruiting

Address

As0010 40001

Gent, ,

As001 40002, Merksem, Belgium

Status

Recruiting

Address

As001 40002

Merksem, ,

As0010 40006, Plovdiv, Bulgaria

Status

Active, not recruiting

Address

As0010 40006

Plovdiv, ,

As0010 40007, Plovdiv, Bulgaria

Status

Completed

Address

As0010 40007

Plovdiv, ,

As0010 40005, Sofia, Bulgaria

Status

Completed

Address

As0010 40005

Sofia, ,

As0010 40008, Sofia, Bulgaria

Status

Completed

Address

As0010 40008

Sofia, ,

As0010 20040, Beijing, China

Status

Recruiting

Address

As0010 20040

Beijing, ,

As0010 20021, Chengdu, China

Status

Recruiting

Address

As0010 20021

Chengdu, ,

As0010 20019, Guangzhou, China

Status

Recruiting

Address

As0010 20019

Guangzhou, ,

As0010 20034, Hefei Shi, China

Status

Recruiting

Address

As0010 20034

Hefei Shi, ,

As0010 20024, Nanjing, China

Status

Recruiting

Address

As0010 20024

Nanjing, ,

As0010 20018, Shanghai, China

Status

Recruiting

Address

As0010 20018

Shanghai, ,

As0010 20020, Shanghai, China

Status

Recruiting

Address

As0010 20020

Shanghai, ,

As0010 20026, Shanghai, China

Status

Recruiting

Address

As0010 20026

Shanghai, ,

As0010 20025, Wenzhou, China

Status

Recruiting

Address

As0010 20025

Wenzhou, ,

As0010 40011, Brno, Czechia

Status

Recruiting

Address

As0010 40011

Brno, ,

As0010 40009, Pardubice, Czechia

Status

Recruiting

Address

As0010 40009

Pardubice, ,

As0010 40013, Praha 11, Czechia

Status

Recruiting

Address

As0010 40013

Praha 11, ,

As0010 40016, Praha 2, Czechia

Status

Recruiting

Address

As0010 40016

Praha 2, ,

As0010 40015, Praha 3, Czechia

Status

Recruiting

Address

As0010 40015

Praha 3, ,

As0010 40014, Praha 4, Czechia

Status

Recruiting

Address

As0010 40014

Praha 4, ,

As0010 40010, Uherské Hradiště, Czechia

Status

Recruiting

Address

As0010 40010

Uherské Hradiště, ,

As0010 40012, Zlín, Czechia

Status

Recruiting

Address

As0010 40012

Zlín, ,

As0010 40018, Boulogne-Billancourt, France

Status

Recruiting

Address

As0010 40018

Boulogne-Billancourt, ,

As0010 40022, Limoges, France

Status

Recruiting

Address

As0010 40022

Limoges, ,

As0010 40021, Orléans, France

Status

Recruiting

Address

As0010 40021

Orléans, ,

As0010 40025, Berlin, Germany

Status

Recruiting

Address

As0010 40025

Berlin, ,

As0010 40028, Berlin, Germany

Status

Recruiting

Address

As0010 40028

Berlin, ,

As0010 40029, Hamburg, Germany

Status

Recruiting

Address

As0010 40029

Hamburg, ,

As0010 40024, Hannover, Germany

Status

Recruiting

Address

As0010 40024

Hannover, ,

As0010 40027, Herne, Germany

Status

Recruiting

Address

As0010 40027

Herne, ,

As0010 40078, Leipzig, Germany

Status

Recruiting

Address

As0010 40078

Leipzig, ,

As0010 40026, Ratingen, Germany

Status

Recruiting

Address

As0010 40026

Ratingen, ,

As0010 40032, Debrecen, Hungary

Status

Recruiting

Address

As0010 40032

Debrecen, ,

As0010 40031, Szeged, Hungary

Status

Recruiting

Address

As0010 40031

Szeged, ,

As0010 40033, Szekesfehervar, Hungary

Status

Recruiting

Address

As0010 40033

Szekesfehervar, ,

As0010 40080, Szombathely, Hungary

Status

Recruiting

Address

As0010 40080

Szombathely, ,

As0010 20030, Chuo Ku, Japan

Status

Recruiting

Address

As0010 20030

Chuo Ku, ,

As0010 20047, Himeji-shi, Japan

Status

Recruiting

Address

As0010 20047

Himeji-shi, ,

As0010 20039, Iruma-Gun, Japan

Status

Recruiting

Address

As0010 20039

Iruma-Gun, ,

As0010 20036, Kawachi-Nagano, Japan

Status

Recruiting

Address

As0010 20036

Kawachi-Nagano, ,

As0010 20045, Kita-Gun, Japan

Status

Recruiting

Address

As0010 20045

Kita-Gun, ,

As0010 20065, Kitakyushu, Japan

Status

Recruiting

Address

As0010 20065

Kitakyushu, ,

As0010 20038, Nankoku, Japan

Status

Recruiting

Address

As0010 20038

Nankoku, ,

As0010 20037, Osaka, Japan

Status

Recruiting

Address

As0010 20037

Osaka, ,

As0010 20084, Saga, Japan

Status

Recruiting

Address

As0010 20084

Saga, ,

As0010 20048, Saitama, Japan

Status

Recruiting

Address

As0010 20048

Saitama, ,

As0010 20031, Sapporo, Japan

Status

Recruiting

Address

As0010 20031

Sapporo, ,

As0010 20042, Sasebo, Japan

Status

Suspended

Address

As0010 20042

Sasebo, ,

As0010 20032, Suita, Japan

Status

Recruiting

Address

As0010 20032

Suita, ,

As0010 20035, Tokyo, Japan

Status

Recruiting

Address

As0010 20035

Tokyo, ,

As0010 40034, Amsterdam, Netherlands

Status

Suspended

Address

As0010 40034

Amsterdam, ,

As0010 40035, Rotterdam, Netherlands

Status

Recruiting

Address

As0010 40035

Rotterdam, ,

As0010 40038, Elbląg, Poland

Status

Recruiting

Address

As0010 40038

Elbląg, ,

As0010 40042, Krakow, Poland

Status

Recruiting

Address

As0010 40042

Krakow, ,

As0010 40037, Lublin, Poland

Status

Recruiting

Address

As0010 40037

Lublin, ,

As0010 40044, Poznań, Poland

Status

Recruiting

Address

As0010 40044

Poznań, ,

As0010 40040, Torun, Poland

Status

Recruiting

Address

As0010 40040

Torun, ,

As0010 40041, Warsaw, Poland

Status

Recruiting

Address

As0010 40041

Warsaw, ,

As0010 40039, Wrocław, Poland

Status

Active, not recruiting

Address

As0010 40039

Wrocław, ,

As0010 40043, Wrocław, Poland

Status

Active, not recruiting

Address

As0010 40043

Wrocław, ,

As0010 40045, Coruna, Spain

Status

Recruiting

Address

As0010 40045

Coruna, ,

As0010 40046, Córdoba, Spain

Status

Recruiting

Address

As0010 40046

Córdoba, ,

As0010 40047, Madrid, Spain

Status

Recruiting

Address

As0010 40047

Madrid, ,

As0010 40048, Santiago De Compostela, Spain

Status

Recruiting

Address

As0010 40048

Santiago De Compostela, ,

As0010 40049, Sevilla, Spain

Status

Recruiting

Address

As0010 40049

Sevilla, ,

As0010 40052, Ankara, Turkey

Status

Recruiting

Address

As0010 40052

Ankara, ,

As0010 40053, Ankara, Turkey

Status

Recruiting

Address

As0010 40053

Ankara, ,

As0010 40050, Istanbul, Turkey

Status

Recruiting

Address

As0010 40050

Istanbul, ,

As0010 40051, Izmir, Turkey

Status

Recruiting

Address

As0010 40051

Izmir, ,

As0010 40057, Edinburgh, United Kingdom

Status

Recruiting

Address

As0010 40057

Edinburgh, ,

As0010 40056, Leeds, United Kingdom

Status

Recruiting

Address

As0010 40056

Leeds, ,

As0010 40054, London, United Kingdom

Status

Suspended

Address

As0010 40054

London, ,

As0010 40055, Norwich, United Kingdom

Status

Recruiting

Address

As0010 40055

Norwich, ,