Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008345

Trial Description

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Title

A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Chronic Plaque Psoriasis (RaPsOdy)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO
who have not yet received any biologic therapy for any indication (other than insulin or
hormones).

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Brief Summary in Scientific Language

Pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center
global study. The primary end point is 75% improvement from baseline according to the
Psoriasis Area and Severity Index (PASI-75). Comparing CHS-0214 to Enbrel for efficacy and
safety at a dosage of 50mg subcutaneous (Sc) twice weekly.

Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center
global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.

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Organizational Data

  •   DRKS00008345
  •   2016/03/11
  •   2014/05/07
  •   no
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Secondary IDs

  •   NCT02134210  (ClinicalTrials.gov)
  •   CHS-0214-04  (Coherus Biosciences, Inc.)
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Health Condition or Problem studied

  •   Plaque Psoriasis
  •   L40 -  Psoriasis
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Interventions/Observational Groups

  •   Biological: Etanercept
  •   Drug: CHS-0214
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- PASI-75; time frame: 12-weeks

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   United States
  •   Australia
  •   Canada
  •   Germany
  •   Israel
  •   Poland
  •   South Africa
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/06/30
  •   496
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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 or 0-5),

- Body Surface Area (BSA) involved with PsO greater than or equal to 10%

- Dermatology Life Quality Index (DQLI) greater than or equal to 10

- Previously received phototherapy or systemic non-biologic therapy for PsO

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Coherus Biosciences, Inc.
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    • Coherus Biosciences, Inc.
    • Barbara K Finck, M.D. 
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    • Regan Burns 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2015/05/04
* This entry means the parameter is not applicable or has not been set.