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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Keywords

Psoriatic Arthritis PsA Bimekizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Pa0008 024 accepting new patients
    San Francisco, California, United States
  • Pa0008 007 accepting new patients
    San Diego, California, United States
  • Pa0008 014 accepting new patients
    Portland, Oregon, United States
  • Pa0008 002 accepting new patients
    Seattle, Washington, United States
  • Pa0008 006 accepting new patients
    Dallas, Texas, United States
  • Pa0008 013 accepting new patients
    Mesquite, Texas, United States
  • Pa0008 011 accepting new patients
    Lansing, Minnesota, United States
  • Pa0008 010 accepting new patients
    Jackson, Tennessee, United States
  • Pa0008 001 accepting new patients
    Duncansville, Pennsylvania, United States
  • Pa0008 028 accepting new patients
    Rochester, New York, United States
  • Pa0008 004 accepting new patients
    Charleston, South Carolina, United States
  • Pa0008 003 accepting new patients
    Hagerstown, Pennsylvania, United States
  • Pa0008 025 accepting new patients
    Lexington, New York, United States
  • Pa0008 005 accepting new patients
    Aventura, Florida, United States
  • Pa0008 008 accepting new patients
    Trumbull, Connecticut, United States
  • Pa0008 012 accepting new patients
    Johnston, Rhode Island, United States
  • Pa0008 604 accepting new patients
    Moscow, Russian Federation
  • Pa0008 605 accepting new patients
    Moscow, Russian Federation
  • Pa0008 607 accepting new patients
    Moscow, Russian Federation
  • Pa0008 606 accepting new patients
    Saint Petersburg, Russian Federation
  • Pa0008 608 accepting new patients
    Saint Petersburg, Russian Federation
  • Pa0008 305 accepting new patients
    Berlin, Germany
  • Pa0008 302 accepting new patients
    Cologne, Germany
  • Pa0008 309 accepting new patients
    Erlangen, Germany
  • Pa0008 304 accepting new patients
    Hamburg, Germany
  • Pa0008 303 accepting new patients
    Herne, Germany
  • Pa0008 307 accepting new patients
    Püttlingen, Germany
  • Pa0008 301 accepting new patients
    Ratingen, Germany
  • Pa0008 452 accepting new patients
    Bialystok, Poland
  • Pa0008 453 accepting new patients
    Elblag, Poland
  • Pa0008 456 accepting new patients
    Elblag, Poland
  • Pa0008 455 accepting new patients
    Krakow, Poland
  • Pa0008 461 accepting new patients
    Lublin, Poland
  • Pa0008 451 accepting new patients
    Poznan, Poland
  • Pa0008 450 accepting new patients
    Torun, Poland
  • Pa0008 454 accepting new patients
    Warszawa, Poland
  • Pa0008 459 accepting new patients
    Warszawa, Poland
  • Pa0008 465 accepting new patients
    Wroclaw, Poland
  • Pa0008 205 in progress, not accepting new patients
    Brno, Czechia
  • Pa0008 207 in progress, not accepting new patients
    Olomouc, Czechia
  • Pa0008 200 accepting new patients
    Prague 4, Czechia
  • Pa0008 210 in progress, not accepting new patients
    Praha 11, Czechia
  • Pa0008 202 in progress, not accepting new patients
    Praha 2, Czechia
  • Pa0008 201 in progress, not accepting new patients
    Praha 4, Czechia
  • Pa0008 209 in progress, not accepting new patients
    Praha 4, Czechia
  • Pa0008 203 in progress, not accepting new patients
    Zlin, Czechia
  • Pa0008 403 in progress, not accepting new patients
    Budakeszierdo, Hungary
  • Pa0008 400 accepting new patients
    Budapest, Hungary
  • Pa0008 401 in progress, not accepting new patients
    Veszprem, Hungary

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
UCB Biopharma S.P.R.L.
ID
NCT02969525
Phase
Phase 2
Lead Scientist
Lianne Gensler
Study Type
Interventional
Last Updated
August 1, 2017
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