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AzTrials

Psoriatic ArthritisPhase 3BE VITALNCT04009499

A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

A Phase 3 study testing Bimekizumab in people with Psoriatic Arthritis, run by UCB Biopharma SRL at 138 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Bimekizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,131 participants
Where
138 sitesin 14 countries
Study dates
13 Aug 2019to 26 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
  • Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria
  • Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Who cannot join

  • Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
  • Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
  • Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated

Trial locations and contacts

138 sites in 14 countries.

138 sites in 14 countries

United States31 sites

  • Pa0012 50029

    Albuquerque, New Mexico, 87102

  • Pa0012 50039

    Atlanta, Georgia, 30342

  • Pa0012 50002

    Austin, Texas, 78731

  • Pa0012 50023

    Baton Rouge, Louisiana, 70836

  • Pa0012 50050

    Beckley, West Virginia, 25801

  • Pa0012 50024

    Boise, Idaho, 83702

  • Pa0012 50047

    Boston, Massachusetts, 02115-5817

  • Pa0012 50010

    Brooklyn, New York, 11201

  • Pa0012 50125

    Charlotte, North Carolina, 28211

  • Pa0012 50049

    Corpus Christi, Texas, 78404

  • Pa0012 50020

    Duncansville, Pennsylvania, 16635

  • Pa0012 50005

    Freehold, New Jersey, 07728

  • Pa0012 50015

    Hagerstown, Maryland, 21740

  • Pa0012 50001

    Jackson, Tennessee, 38305

  • Pa0012 50008

    Johnston, Rhode Island, 02919

  • Pa0012 50019

    Lansing, Michigan, 48911

  • Pa0012 50028

    Lexington, Kentucky, 40504

  • Pa0012 50012

    Memphis, Tennessee, 38119-5214

  • Pa0012 50036

    Mesquite, Texas, 75150

  • Pa0012 50011

    New York, New York, 10029

  • Pa0012 50007

    Orangeburg, South Carolina, 29118

  • Pa0012 50033

    Palm Harbor, Florida, 34684

  • Pa0012 50017

    Phoenix, Arizona, 85037

  • Pa0012 50034

    Rochester, New York, 14642

  • Pa0012 50035

    San Diego, California, 92128

  • Pa0012 50016

    St Louis, Missouri, 63141

  • Pa0012 50037

    Tampa, Florida, 33613

  • Pa0012 50040

    Vandalia, Ohio, 45377

  • Pa0012 50009

    Waco, Texas, 76710

  • Pa0012 50031

    Winston-Salem, North Carolina, 27104

  • Pa0012 50006

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland19 sites

  • Pa0012 40093

    Bialystok

  • Pa0012 40119

    Bydgoszcz

  • Pa0012 40038

    Elblag

  • Pa0012 40088

    Elblag

  • Pa0012 40096

    Gdynia

  • Pa0012 40042

    Krakow

  • Pa0012 40092

    Krakow

  • Pa0012 40037

    Lublin

  • Pa0012 40091

    Nowa Sól

  • Pa0012 40044

    Poznan

  • Pa0012 40090

    Poznan

  • Pa0012 40041

    Warsaw

  • Pa0012 40094

    Warsaw

  • Pa0012 40097

    Warsaw

  • Pa0012 40098

    Warsaw

  • Pa0012 40118

    Warsaw

  • Pa0012 40039

    Wroclaw

  • Pa0012 40043

    Wroclaw

  • Pa0012 40095

    Wroclaw

Other trials in Poland

Russia17 sites

  • Pa0012 20002

    Moscow

  • Pa0012 20005

    Moscow

  • Pa0012 20010

    Moscow

  • Pa0012 20017

    Moscow

  • Pa0012 20013

    Petrozavodsk

  • Pa0012 20012

    Ryazan

  • Pa0012 20016

    Ryazan

  • Pa0012 20001

    Saint Petersburg

  • Pa0012 20003

    Saint Petersburg

  • Pa0012 20004

    Saint Petersburg

  • Pa0012 20009

    Saint Petersburg

  • Pa0012 20083

    Saint Petersburg

  • Pa0012 20007

    Saratov

  • Pa0012 20014

    Ulyanovsk

  • Pa0012 20006

    Vladimir

  • Pa0012 20008

    Yaroslavl

  • Pa0012 20015

    Yaroslavl

Other trials in Russia

Japan14 sites

  • Pa0012 20035

    Bunkyō City

  • Pa0012 20030

    Chūōku

  • Pa0012 20043

    Itabashi-ku

  • Pa0012 20036

    Kawachi-Nagano

  • Pa0012 20045

    Kita-gun

  • Pa0012 20049

    Kitakyushu

  • Pa0012 20044

    Minatoku

  • Pa0012 20033

    Nagoya

  • Pa0012 20041

    Osaka

  • Pa0012 20046

    Osaka

  • Pa0012 20048

    Saitama

  • Pa0012 20031

    Sapporo

  • Pa0012 20042

    Sasebo

  • Pa0012 20032

    Suita

Other trials in Japan

Czechia11 sites

  • Pa0012 40061

    Brno

  • Pa0012 40065

    Brno

  • Pa0012 40062

    Moravska Ostrava A Privoz

  • Pa0012 40009

    Pardubice

  • Pa0012 40013

    Prague

  • Pa0012 40014

    Prague

  • Pa0012 40015

    Prague

  • Pa0012 40063

    Prague

  • Pa0012 40066

    Prague

  • Pa0012 40010

    Uherské Hradiště

  • Pa0012 40012

    Zlín

Other trials in Czechia

Germany10 sites

  • Pa0012 40074

    Bad Doberan

  • Pa0012 40025

    Berlin

  • Pa0012 40076

    Cottbus

  • Pa0012 40023

    Erlangen

  • Pa0012 40117

    Frankfurt am Main

  • Pa0012 40029

    Hamburg

  • Pa0012 40071

    Hamburg

  • Pa0012 40027

    Herne

  • Pa0012 40078

    Leipzig

  • Pa0012 40026

    Ratingen

Other trials in Germany

Spain8 sites

  • Pa0012 40045

    A Coruña

  • Pa0012 40105

    Córdoba

  • Pa0012 40102

    Málaga

  • Pa0012 40101

    Sabadell

  • Pa0012 40104

    Santiago de Compostela

  • Pa0012 40049

    Seville

  • Pa0012 40106

    Seville

  • Pa0012 40099

    Vigo

Other trials in Spain

Hungary7 sites

  • Pa0012 40081

    Budapest

  • Pa0012 40083

    Budapest

  • Pa0012 40032

    Debrecen

  • Pa0012 40030

    Eger

  • Pa0012 40082

    Kistarcsa

  • Pa0012 40033

    Székesfehérvár

  • Pa0012 40079

    Szentes

Other trials in Hungary

Australia6 sites

  • Pa0012 30005

    Camberwell

  • Pa0012 30002

    Clayton

  • Pa0012 30008

    Hobart

  • Pa0012 30003

    Maroochydore

  • Pa0012 30007

    Victoria Park

  • Pa0012 30006

    Woodville South

Other trials in Australia

Canada4 sites

  • Pa0012 50041

    Québec

  • Pa0012 50042

    Rimouski

  • Pa0012 50043

    Sydney

  • Pa0012 50044

    Trois-Rivières

Other trials in Canada

Belgium3 sites

  • Pa0012 40003

    Genk

  • Pa0012 40002

    Leuven

  • Pa0012 40059

    Mons

Other trials in Belgium

Italy3 sites

  • Pa0012 40084

    Catania

  • Pa0012 40087

    Milan

  • Pa0012 40086

    Reggio Emilia

Other trials in Italy

United Kingdom3 sites

  • Pa0012 40109

    Oxford

  • Pa0012 40116

    Peterborough

  • Pa0012 40107

    Wolverhampton

Other trials in United Kingdom

France2 sites

  • Pa0012 40068

    Chambray-lès-Tours

  • Pa0012 40019

    Paris

Other trials in France

About this study

Official title: A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

Being tested
Bimekizumab
Keywords
Psoriatic Arthritis, PsA, Bimekizumab
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BimekizumabDrug

    Also called BKZ, UCB4940

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

Study groups in NCT04009499
Study groupRoleWhat they receive
Bimekzumab dosage regimenExperimentalSubjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.
Receives: Drug: Bimekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs) during the study

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)

  2. Incidence of treatment-emergent serious adverse events (SAEs) during the study

    A serious adverse event (SAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires in patient hospitalization or prolongation of existing hospitalization
    • Is a congenital anomaly or birth defect
    • Is an infection that requires treatment parenteral antibiotics
    • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

    Measured: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)

Secondary outcomes (28)

  1. TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)

  2. American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  3. American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  4. American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

  5. American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  6. American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  7. American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

  8. American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  9. American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  10. American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011

    The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

  11. Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011

    The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

    The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

    The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  12. Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011

    The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

    The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

    The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  13. Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011

    The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

    The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

    The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

  14. Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011

    The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

    The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

    The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  15. Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011

    The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

    The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

    The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  16. Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011

    The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

    The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

    The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

  17. Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011

    A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011.

    An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  18. Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011

    A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011.

    An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  19. Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011

    A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011.

    An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

  20. Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011

    Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  21. Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011

    Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  22. Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011

    Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

  23. Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011

    Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  24. Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011

    Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  25. Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011

    Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

  26. Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011

    Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 24 in PA0012

  27. Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011

    Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 52 in PA0012

  28. Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011

    Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.

    Measured: Baseline of PA0010 or PA0011, Week 140 in PA0012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start13 Aug 2019
  3. Primary completion26 May 2026
  4. Study completion26 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009499
Sponsor's protocol ID
PA0012
Other IDs
2018-004725-86, 2023-506528-95, U1111-1304-6874, 2023, 2018
Acronym
BE VITAL
Status last verified
Aug 2026
First submitted
2 Jul 2019
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Publications

  • Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.

    PubMed 39120849

  • Gossec L, Orbai AM, de Wit M, Coates LC, Ogdie A, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 Sep 1;63(9):2399-2410. doi: 10.1093/rheumatology/keae277.

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  • Kristensen LE, Tillett W, Nash P, Coates LC, Mease PJ, Ogdie A, Gisondi P, Ink B, Prickett AR, Bajracharya R, Taieb V, Lyris N, Lambert J, Walsh JA. Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies. Ther Adv Musculoskelet Dis. 2024 Nov 11;16:1759720X241288071. doi: 10.1177/1759720X241288071. eCollection 2024.

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  • Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2025 Aug;12(4):609-612. doi: 10.1007/s40744-025-00764-8. Epub 2025 May 10.

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  • Gossec L, Coates LC, Landewe RBM, Mease PJ, Merola JF, Ritchlin CT, Tanaka Y, Asahina A, Proft F, Goldammer N, Manente M, Ink B, Bajracharya R, Coarse J, McInnes IB. Bimekizumab safety and efficacy in patients with psoriatic arthritis: 3-year results from two phase 3 studies. Rheumatology (Oxford). 2026 May 5;65(5):keag118. doi: 10.1093/rheumatology/keag118.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimekizumab in people with Psoriatic Arthritis, run by UCB Biopharma SRL at 138 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Poland, Russia, Japan, Czechia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) during the study (time frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009499, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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