Clinical Trial: A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chroni

Brief Summary: The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.

Detailed Summary:
Sponsor: UCB Biopharma S.P.R.L.

Current Primary Outcome: Percentage of subjects achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16 [ Time Frame: Week 16 ]

This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of subjects who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear response (with at least 2-category improvement) at Week 16 [ Time Frame: Week 16 ]
    This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).
  • Percentage of subjects achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16 [ Time Frame: Week 16 ]
    This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).
  • Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Week 16 ]
    This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).
  • Change from Baseline in Itch Numeric Rating Scale at Week 16 [ Time Frame: Week 16 ]
    This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).
  • Plasma concentration of Certolizumab Pegol (CZP) [ Time Frame: Blood samples will be collected at baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60. ]
    Blood samples will be collected at indicated time points to determine the CZP plasma concentration.
  • Anti-Certolizumab Pegol-antibody levels in plasma [ Time Frame: Blood samples will be collected at baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60. ]
    Blood samples will be collected at indicated time points to determine the anti-CZP-antibody concentration.


Original Secondary Outcome:

  • Percentage of subjects who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear response (with at least 2-category improvement) at Week 16 [ Time Frame: Week 16 ]
    This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).
  • Percentage of subjects achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16 [ Time Frame: Week 16 ]
    This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).
  • Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Week 16 ]
    This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).
  • Change from Baseline in Itch Numeric Rating Scale at Week 16 [ Time Frame: Week 16 ]
    This Outcome Measure applies to subjects with moderate to severe chronic plaque Psoriasis (PSO).
  • Plasma concentration of Certolizumab Pegol (CZP) [ Time Frame: Blood samples will be collected at baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60. ]
  • Anti-Certolizumab Pegol-antibody levels in plasma [ Time Frame: Blood samples will be collected at baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60. ]


Information By: UCB Pharma

Dates:
Date Received: February 9, 2017
Date Started: February 21, 2017
Date Completion: January 2019
Last Updated: May 3, 2017
Last Verified: May 2017