Phase 3 N=545 Randomized Quadruple-blind Treatment

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

Plaque Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT02489227 ↗

Enrolled (actual)

545

Serious AEs

1.4%

Results posted

Oct 2019

Primary outcome: Primary: 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 — 203; 211 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CHS-1420 (Drug); Adalimumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coherus Oncology, Inc.
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	203; 211	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02489227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.