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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Coherus Biosciences, Inc.

ClinicalTrials.gov Identifier:

NCT02489227

First received: July 1, 2015

Last updated: June 9, 2017

Last verified: June 2017

History of Changes

Purpose

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

Condition	Intervention	Phase
Plaque Psoriasis	Drug: CHS-1420 Drug: Adalimumab	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Coherus Biosciences, Inc.:

Primary Outcome Measures:

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 ]


Enrollment:	545
Study Start Date:	August 2015
Study Completion Date:	March 2017
Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 reassigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. 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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02489227

Locations


United States, Missouri
Central Dermatology
Saint Louis, Missouri, United States, 63117

Sponsors and Collaborators

Coherus Biosciences, Inc.

Investigators


Study Director:	Barbara K Finck, M.D.	Coherus Biosciences, Inc.

More Information


Responsible Party:	Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT02489227 History of Changes
Other Study ID Numbers:	CHS-1420-02
Study First Received:	July 1, 2015
Last Updated:	June 9, 2017

Keywords provided by Coherus Biosciences, Inc.:


PsO

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases	Adalimumab Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on July 17, 2017

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