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

Coherus Oncology, Inc.545 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

545

Conditions

Plaque Psoriasis

Interventions

CHS-1420DRUG

AdalimumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (99)

Outcomes

Primary Outcomes

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

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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Kenneth M Stein, MD

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HealthCare Partners Medical Group Clinical Research Center

Torrance, California, United States

Horizons Clinical Research Center, LLC.

Denver, Colorado, United States

New England Research Associates LLC

Trumbull, Connecticut, United States

Francisco A Kerdel, MD

Coral Gables, Florida, United States

Linda Tripodis Murray, DO

Pinellas Park, Florida, United States

ACRC-Dermatology

West Palm Beach, Florida, United States

...and 89 more locations