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

Information source: Coherus Biosciences, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis

Intervention: CHS-1420 (Drug); Adalimumab (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Coherus Biosciences, Inc.

Official(s) and/or principal investigator(s):
Barbara K Finck, M.D., Study Director, Affiliation: Coherus Biosciences, Inc.

Overall contact:
Regan Burns, Phone: 650-649-3582, Email: rburns@coherus.com

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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

Detailed description: This is a 31-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, 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Regan Burns, Phone: 650-649-3582, Email: rburns@coherus.com

Additional Information

Starting date: August 2015
Last updated: July 1, 2015

Page last updated: August 23, 2015

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