A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis (BE ACTIVE 2)

A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis

This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Bimekizumab

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia
    • Pa0009 205
  • Olomouc, Czechia
    • Pa0009 207
  • Praha, Czechia
    • Pa0009 202
  • Praha 11, Czechia
    • Pa0009 210
  • Praha 4, Czechia
    • Pa0009 201
  • Zlín, Czechia
    • Pa0009 203
• Germany
  • Cologne, Germany
    • Pa0009 302
  • Erlangen, Germany
    • Pa0009 309
  • Hamburg, Germany
    • Pa0009 304
  • Ratingen, Germany
    • Pa0009 301
• Hungary
  • Budapest, Hungary
    • Pa0009 403
  • Veszprém, Hungary
    • Pa0009 401
• Poland
  • Bialystok, Poland
    • Pa0009 452
  • Elbląg, Poland
    • Pa0009 453
  • Elbląg, Poland
    • Pa0009 456
  • Kraków, Poland
    • Pa0009 455
  • Poznań, Poland
    • Pa0009 451
  • Toruń, Poland
    • Pa0009 450
  • Warsaw, Poland
    • Pa0009 454
  • Warsaw, Poland
    • Pa0009 459
  • Wrocław, Poland
    • Pa0009 465
• Russian Federation
  • Moscow, Russian Federation
    • Pa0009 604
  • Moscow, Russian Federation
    • Pa0009 605
  • Moscow, Russian Federation
    • Pa0009 607
  • Saint Petersburg, Russian Federation
    • Pa0009 606
  • Saint Petersburg, Russian Federation
    • Pa0009 608
• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Pa0009 025
  • Maryland
    • Hagerstown, Maryland, United States, 21502
      • Pa0009 003
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Pa0009 011
  • New York
    • Rochester, New York, United States, 14642
      • Pa0009 028
  • Oregon
    • Portland, Oregon, United States, 97239
      • Pa0009 014
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Pa0009 001
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Pa0009 012
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Pa0009 004
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Pa0009 010
  • Texas
    • Dallas, Texas, United States, 75231
      • Pa0009 006
    • Mesquite, Texas, United States, 75150
      • Pa0009 013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
• Subject completed PA0008 without meeting any withdrawal criteria
• Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
• Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active

Exclusion Criteria:

• Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
• Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
• Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into PA0009

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimekizumab; Subjects will receive bimekizumab up to 2 years.	Drug: Bimekizumab; Bimekizumab at a prespecified dose.; Other Names: UCB4940

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant 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. TEAEs were defined as events with onset date on or after the start date of study medication in PA0009.	From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study	A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.	From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Withdrew Due to Treatment-emergent Adverse Event (TEAE) During the Study	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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.	From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 Calculated Relative to Baseline of PA0008	The ACR20 response rate was based on 20% or greater improvement relative to Baseline of PA0008 in the following measures: Tender Joint Count (TJC) based on 78 joints, Swollen Joint Count (SJC) based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA), Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA), Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP), Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI), Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP). Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.	Baseline of PA0008, Week 48
Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 Calculated Relative to Baseline of PA0008	The ACR50 response rate was based on 50% or greater improvement relative to Baseline of PA0008 in the following measures: TJC based on 78 joints, SJC based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by PGADA, Disease activity as assessed by PhGADA, Pain as assessed by PtAAP, Physical function as assessed by HAQ-DI, Acute phase response as assessed by hs CRP. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.	Baseline of PA0008, Week 48
Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 Calculated Relative to Baseline of PA0008	The ACR70 response rate was based on 70% or greater improvement relative to Baseline of PA0008 in the following measures: TJC based on 78 joints, SJC based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by PGADA, Disease activity as assessed by PhGADA, Pain as assessed by PtAAP, Physical function as assessed by HAQ-DI, Acute phase response as assessed by hs CRP. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.	Baseline of PA0008, Week 48
Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 Calculated Relative to Baseline of PA0008	The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process). Each item was scored as 0 = not tender or 1 = tender and then were summed for a possible score of 0 to 13, with higher scores indicating worse enthesitis. If 7 or more items were available, MASES was calculated by dividing the summed score with the number of assessments and multiplying the result by 13. If less than 7 items were available, MASES was treated as missing.	Baseline of PA0008, Week 48
Change From Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 Calculated Relative to Baseline of PA0008	Presence of dactylitis was assessed using the LDI basic which evaluated for a greater than or equal to (>=) 10% difference in the circumference of the digit compared to the opposite digit and was then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present). The results from each digit with dactylitis were summed to produce a final score. For the final score, the minimum value for LDI is zero and there is no maximum value. A low score indicates less dactylitis symptoms. A score of zero is considered dactylitis free. Observed values have been reported in this outcome measure.	Baseline of PA0008, Week 48
Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 Calculated Relative to Baseline of PA0008	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with psoriasis (PSO) for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. For the Final score, minimum possible PASI value is 0= no disease, maximum value is 72= maximal disease. Missing PASI responses were imputed using least observation carried forward (LOCF) for any visits where the corresponding BSA has not increased compared to the preceding visit.	Baseline of PA0008, Week 48
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 Calculated Relative to Baseline of PA0008	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. For the final score, minimum possible PASI value is 0= no disease, maximum value is 72= maximal disease. Missing PASI responses were imputed using LOCF for any visits where the corresponding BSA has not increased compared to the preceding visit.	Baseline of PA0008, Week 48

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, +1 8445992273 (UCB)

Publications and helpful links

General Publications

• Mease PJ, Asahina A, Gladman DD, Tanaka Y, Tillett W, Ink B, Assudani D, de la Loge C, Coarse J, Eells J, Gossec L. Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE. Rheumatology (Oxford). 2023 Feb 1;62(2):617-628. doi: 10.1093/rheumatology/keac353.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): October 29, 2020
• Study Completion (Actual): October 29, 2020

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Psoriatic Arthritis; PsA; Bimekizumab
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: PA0009; 2017-001003-74 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No