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

Sponsor
UCB Biopharma SRL (Industry)
Overall Status
Completed
CT.gov ID
NCT03347110
Collaborator
(none)
184
Enrollment
37
Locations
1
Arm
35.2
Actual Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
184 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Actual Study Start Date :
Nov 22, 2017
Actual Primary Completion Date :
Oct 29, 2020
Actual Study Completion Date :
Oct 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bimekizumab

Subjects will receive bimekizumab up to 2 years.

Drug: Bimekizumab
Bimekizumab at a prespecified dose.
Other Names:
  • UCB4940

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events (TEAEs) during the study [From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)]

      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.

    2. Incidence of treatment-emergent serious adverse events (SAEs) during the study [From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)]

      Once it is determined that a subject experienced an adverse event (AE), the seriousness of the AE must be determined. An SAE must meet 1 or more of the following criteria: death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.) product.

    Secondary Outcome Measures

    1. Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study [From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)]

      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.

    2. ACR20 (American College of Rheumatology 20% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 [Baseline of PA0008, Week 48]

      The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0008.

    3. ACR50 (American College of Rheumatology 50% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 [Baseline of PA0008, Week 48]

      The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0008.

    4. ACR70 (American College of Rheumatology 70% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 [Baseline of PA0008, Week 48]

      The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0008.

    5. Change from Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 calculated relative to Baseline of PA0008 [Baseline of PA0008, Week 48]

      The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses each scored as 0 or 1 and then summed for a possible score of 0 to 13.

    6. Change from Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 calculated relative to Baseline of PA0008 [Baseline of PA0008, Week 48]

      Presence of dactylitis will be assessed 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).

    7. PASI75 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008 [Baseline of PA0008, Week 48]

      The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline in PA0008. 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.

    8. PASI90 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008 [Baseline of PA0008, Week 48]

      The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline in PA0008. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pa0009 025 Lexington Kentucky United States 40504
    2 Pa0009 003 Hagerstown Maryland United States 21502
    3 Pa0009 011 Lansing Michigan United States 48910
    4 Pa0009 028 Rochester New York United States 14642
    5 Pa0009 014 Portland Oregon United States 97239
    6 Pa0009 001 Duncansville Pennsylvania United States 16635
    7 Pa0009 012 Johnston Rhode Island United States 02919
    8 Pa0009 004 Charleston South Carolina United States 29406
    9 Pa0009 010 Jackson Tennessee United States 38305
    10 Pa0009 006 Dallas Texas United States 75231
    11 Pa0009 013 Mesquite Texas United States 75150
    12 Pa0009 205 Brno Czechia
    13 Pa0009 207 Olomouc Czechia
    14 Pa0009 210 Praha 11 Czechia
    15 Pa0009 201 Praha 4 Czechia
    16 Pa0009 202 Praha Czechia
    17 Pa0009 203 Zlín Czechia
    18 Pa0009 302 Cologne Germany
    19 Pa0009 309 Erlangen Germany
    20 Pa0009 304 Hamburg Germany
    21 Pa0009 301 Ratingen Germany
    22 Pa0009 403 Budapest Hungary
    23 Pa0009 401 Veszprém Hungary
    24 Pa0009 452 Bialystok Poland
    25 Pa0009 453 Elbląg Poland
    26 Pa0009 456 Elbląg Poland
    27 Pa0009 455 Kraków Poland
    28 Pa0009 451 Poznań Poland
    29 Pa0009 450 Toruń Poland
    30 Pa0009 454 Warsaw Poland
    31 Pa0009 459 Warsaw Poland
    32 Pa0009 465 Wrocław Poland
    33 Pa0009 604 Moscow Russian Federation
    34 Pa0009 605 Moscow Russian Federation
    35 Pa0009 607 Moscow Russian Federation
    36 Pa0009 606 Saint Petersburg Russian Federation
    37 Pa0009 608 Saint Petersburg Russian Federation

    Sponsors and Collaborators

    • UCB Biopharma SRL

    Investigators

    • Study Director: UCB Cares, +1 8445992273 (UCB)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UCB Biopharma SRL
    ClinicalTrials.gov Identifier:
    NCT03347110
    Other Study ID Numbers:
    • PA0009
    • 2017-001003-74
    First Posted:
    Nov 20, 2017
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by UCB Biopharma SRL
    Bimekizumab
    Psoriatic Arthritis
    PsA
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Psoriatic

    Study Results

    No Results Posted as of Oct 29, 2021