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Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis (PsOsim)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489227
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : October 18, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Coherus Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 2, 2015
Results First Submitted Date  ICMJE July 3, 2019
Results First Posted Date  ICMJE October 18, 2019
Last Update Posted Date February 13, 2020
Study Start Date  ICMJE August 2015
Actual Primary Completion Date May 6, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12 [ Time Frame: 12 weeks ]
The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12 [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Official Title  ICMJE A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Brief Summary This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.
Detailed Description

This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO.

The study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: CHS-1420
  • Drug: Adalimumab
    Other Name: Humira
Study Arms  ICMJE
  • Active Comparator: Humira (adalimumab)
    Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be assigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. The assignments for treatment sequences (Treatment Period 1 and Treatment Period 2) were made randomly at the beginning of Treatment Period 1. At week 24 subjects will switch to CHS-1420 open label until study end.
    Interventions:
    • Drug: CHS-1420
    • Drug: Adalimumab
  • Experimental: CHS-1420
    CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.
    Intervention: Drug: CHS-1420
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2016)
545
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2015)
500
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date May 6, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female adults
  • PsO diagnosis for 6 months
  • Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5),
  • Body Surface Area (BSA) involved with PsO greater than or equal to 10%

Exclusion Criteria:

  • Forms of psoriasis other than PsO
  • Drug induced psoriasis
  • Positive QuantiFERON-tuberculosis (TB) Gold Test
  • Presence of significant comorbid conditions
  • Chemistry and hematology values outside protocol specified range
  • Major systemic infections
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Chile,   Croatia,   Estonia,   Georgia,   Israel,   Italy,   Latvia,   Moldova, Republic of,   Poland,   Russian Federation,   Slovakia,   South Africa,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02489227
Other Study ID Numbers  ICMJE CHS-1420-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coherus Biosciences, Inc.
Study Sponsor  ICMJE Coherus Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Barbara P Finck, M.D. Coherus Biosciences, Inc.
PRS Account Coherus Biosciences, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP