A 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

Part of paid clinical trials in San Diego, California.

Sponsor
UCB Biopharma S.P.R.L.
Study ID
NCT02969525
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — OTHER
  • Bimekizumab — DRUG
    Bimekizumab in different dosage regimens.

Study Details

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

Key Dates

Start date
Oct 31, 2016
Status verified
Mar 2023
Primary completion
Nov 30, 2017
Completion
Jul 31, 2018

Study Design

Enrollment
206 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • Experimental: Bimekizumab dosage regimen 2
    Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
  • Experimental: Bimekizumab dosage regimen 3
    Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
  • 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.

Primary Outcome Measure

ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 [ Time Frame: Week 12 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Pa0008 007San DiegoCalifornia92037-
Pa0008 005AventuraFlorida33180-
Pa0008 003HagerstownMaryland21740-
Pa0008 011LansingMinnesota48910-
Pa0008 025LexingtonNew York40504-
Pa0008 014PortlandOregon97239-
Pa0008 001DuncansvillePennsylvania16635-
Pa0008 012JohnstonRhode Island02919-
Pa0008 004CharlestonSouth Carolina29406-93-
Pa0008 010JacksonTennessee38305-
Pa0008 006DallasTexas75231-
Pa0008 013MesquiteTexas75150-
Pa0008 002SeattleWashington98122-

Find similar trials in San Diego, CA

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Pa0008 007· San Diego, CAPa0008 005· Aventura, FLPa0008 003· Hagerstown, MDPa0008 011· Lansing, MNPa0008 025· Lexington, NYPa0008 014· Portland, OR

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