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

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ClinicalTrials.gov Identifier: NCT02489227
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : October 18, 2019
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Coherus Biosciences, Inc.

Study Description
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Brief Summary:
This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: CHS-1420 Drug: Adalimumab Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2015
Actual Primary Completion Date : May 6, 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: CHS-1420
Drug: Adalimumab
Other Name: Humira
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.
 Drug: CHS-1420


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT02489227


Locations
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Sponsors and Collaborators
Coherus Biosciences, Inc.
Investigators
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Study Director: Barbara P Finck, M.D. Coherus Biosciences, Inc.
  Study Documents (Full-Text)

Documents provided by Coherus Biosciences, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] July 16, 2015

More Information
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Responsible Party: Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02489227    
Other Study ID Numbers: CHS-1420-02
First Posted: July 2, 2015    Key Record Dates
Results First Posted: October 18, 2019
Last Update Posted: April 8, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Coherus Biosciences, Inc.:
PsO
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
 Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents