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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Coherus Oncology, Inc.
Study ID
NCT02489227
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.

Key Dates

Start date
Aug 31, 2015
Status verified
Mar 2020
Primary completion
May 6, 2016
Completion
Mar 31, 2017

Study Design

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

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Locations (28)

FacilityCityStateZIPSite coordinators
Sadra Sasha Jazayeri, MDPhoenixArizona85032-
Encino Research CenterEncinoCalifornia91436-
Center for Dermatology and Laser SurgerySacramentoCalifornia95819-
Kenneth M Stein, MDSanta RosaCalifornia95405-
HealthCare Partners Medical Group Clinical Research CenterTorranceCalifornia90503-
Horizons Clinical Research Center, LLC.DenverColorado80220-
New England Research Associates LLCTrumbullConnecticut06611-
Francisco A Kerdel, MDCoral GablesFlorida33134-
Linda Tripodis Murray, DOPinellas ParkFlorida33781-
ACRC-DermatologyWest Palm BeachFlorida33406-
Mark A Knautz, MDMariettaGeorgia30060-
The Indiana Clinical Trials CenterPlainfieldIndiana46168-
Grekin Skin InstituteWarrenMichigan48088-
Jack C Scott, MDEdinaMinnesota55435-
Central DermatologySt LouisMissouri63117-
Craig L Leonardi, MDSt LouisMissouri63117-
PMG Research of Raleigh, LLCCaryNorth Carolina27518-
Box Arthritis & Rheumetology of the CarolinasCharlotteNorth Carolina28210-
Michael Joseph Noss, MDCincinnatiOhio45249-
Central Sooner ResearchNormanOklahoma73031-
Health Research of OklahomaOklahoma CityOklahoma73103-
Dermatology and Skin Surgery Center, PCExtonPennsylvania19341-
James Henry Kopp, MDAndersonSouth Carolina29621-
PMG Research of Bristol, LLCBristolTennessee37620-
Arlington Research Center, Inc.ArlingtonTexas76011-
Center for Clinical StudiesHoustonTexas77065-
Center for Clinical Studies TMC/ Museum District OfficeHoustonTexas77004-
Center for Clinical StudiesWebsterTexas77598-

Find similar trials in Phoenix, AZ

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Sadra Sasha Jazayeri, MD· Phoenix, AZEncino Research Center· Encino, CACenter for Dermatology and Laser Surgery· Sacramento, CAKenneth M Stein, MD· Santa Rosa, CAHealthCare Partners Medical Group Clinical Research Center· Torrance, CAHorizons Clinical Research Center, LLC.· Denver, CO

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