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

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ClinicalTrials.gov Identifier: NCT03347110
Recruitment Status : Active, not recruiting
First Posted : November 20, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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
Psoriatic Arthritis Drug: Bimekizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
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 : November 22, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bimekizumab
Subjects will receive bimekizumab up to 2 years.
Drug: Bimekizumab
Bimekizumab at a prespecified dose.
Other Name: UCB4940




Primary Outcome Measures :
  1. Incidence of Adverse Event (AE) during the study [ Time Frame: From Entry Visit (Visit 1) 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 Serious Adverse Event (SAE) during the study [ Time Frame: From Entry Visit (Visit 1) 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 Adverse Event (AE) during the study [ Time Frame: From Entry Visit (Visit 1) 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 [ Time Frame: 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. ACR20 (American College of Rheumatology 20% Improvement) Response at Week 48 calculated relative to PA0009 entry value [ Time Frame: PA0009 Entry Visit, Week 48 ]
    The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to PA0009 entry value.

  4. ACR50 (American College of Rheumatology 50% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]
    The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0008.

  5. ACR50 (American College of Rheumatology 50% Improvement) Response at Week 48 calculated relative to PA0009 entry value [ Time Frame: PA0009 Entry Visit, Week 48 ]
    The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to PA0009 entry value.

  6. ACR70 (American College of Rheumatology 70% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]
    The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0008.

  7. ACR70 (American College of Rheumatology 70% Improvement) Response at Week 48 calculated relative to PA0009 entry value [ Time Frame: PA0009 Entry Visit, Week 48 ]
    The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to PA0009 entry value.

  8. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: 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.

  9. Change from PA0009 entry value in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 [ Time Frame: PA0009 Entry Visit, 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.

  10. Change from Baseline in the Leeds Dactylitis Index (LDI) at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: 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).

  11. Change from PA0009 entry value in the Leeds Dactylitis Index (LDI)at Week 48 [ Time Frame: PA0009 Entry Visit, 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).

  12. PASI75 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: 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.


  13. PASI75 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to PA0009 entry value [ Time Frame: PA0009 Entry Visit, Week 48 ]

    The PASI75 response is based on at least 75% improvement in the PASI score compared to PA0009 entry value.

    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.


  14. PASI90 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: 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.


  15. PASI90 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to PA0009 entry value [ Time Frame: PA0009 Entry Visit, Week 48 ]

    The PASI90 response is based on at least 90% improvement in the PASI score compared to PA0009 entry value.

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347110


  Show 37 Study Locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 8445992273 (UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03347110     History of Changes
Other Study ID Numbers: PA0009
2017-001003-74 ( EudraCT Number )
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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 Pharma ( UCB Biopharma S.P.R.L. ):
Bimekizumab
Psoriatic Arthritis
PsA

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases