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

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: CHS-1420; Drug: Adalimumab

• Registration Number: NCT02489227
• Lead Sponsor: Coherus Biosciences, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Study Start: 2015-08
• Primary Completion: 2016-05-06
• Study Completion: 2017-03
• Disposition First Submitted: 2017-05-31
• Disposition First Submitted QC: 2017-06-09
• Disposition First Posted: 2017-06-14
• Results First Submitted: 2019-07-03
• Results First Submitted QC: 2019-09-26
• Results First Posted: 2019-10-18
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 545

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHS-1420	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.
Humira (adalimumab)	CHS-1420	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.
Humira (adalimumab)	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.

Primary Outcome Measures

Name	Time	Method
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	12 weeks	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.

Trial Locations

Locations (97)

Sadra Sasha Jazayeri, MD; 🇺🇸 Phoenix, Arizona, United States

Encino Research Center; 🇺🇸 Encino, California, United States

Center for Dermatology and Laser Surgery; 🇺🇸 Sacramento, California, United States

Kenneth M Stein, MD; 🇺🇸 Santa Rosa, California, United States

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

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