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Trial record 2 of 4 for:    bimekizumab | Psoriatic Arthritis

A Multicenter Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis.

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ClinicalTrials.gov Identifier: NCT02969525
Recruitment Status : Active, not recruiting
First Posted : November 21, 2016
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Other: Placebo Drug: Bimekizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Active Psoriatic Arthritis
Actual Study Start Date : October 2016
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Other: Placebo
Experimental: Bimekizumab dosage regimen 1
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 1 and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Other Name: UCB4940

Experimental: Bimekizumab dosage regimen 2
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Other Name: UCB4940

Experimental: Bimekizumab dosage regimen 3
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Other Name: UCB4940

Experimental: Bimekizumab dosage regimen 4
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Other Name: UCB4940




Primary Outcome Measures :
  1. ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 [ Time Frame: Week 12 ]
  2. ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 [ Time Frame: Week 12 ]
  3. PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 [ Time Frame: Week 12 ]
  4. PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 [ Time Frame: Week 12 ]


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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:

  • Subject has a documented diagnosis of adult-onset PsA classified by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must have at Baseline tender joint count (TJC) >=3 out of 78 and swollen joint count (SJC) >=3 out of 76
  • Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
  • Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis
  • Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline
  • Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit
  • Subjects taking methotrexate (MTX) (<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
  • Subjects taking leflunomide (LEF; <=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16
  • Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:

    1. experienced an inadequate response to previous treatment given for at least 3 months
    2. been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
    3. lost access to TNF inhibitor for other reasons

Exclusion Criteria:

  • Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1
  • Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
  • Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis
  • Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline
  • Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection
  • Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis
  • Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:

    1. <= 3 excised or ablated basal cell carcinomas of the skin
    2. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
    3. Actinic keratosis (-es)
    4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening

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): NCT02969525


  Show 40 Study Locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 844 599 2273(UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02969525     History of Changes
Other Study ID Numbers: PA0008
2016-001103-23 ( EudraCT Number )
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: May 2018

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Psoriatic Arthritis
PsA
Bimekizumab

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