Phase 3
Completed N=521
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
Source: ClinicalTrials.gov NCT02134210 ↗Enrolled (actual)
521
Serious AEs
3.3%
Results posted
May 2019
Primary outcomePrimary: Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 — 142; 147 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 |
142; 147 | — |
| PRIMARY Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks |
-73.4; -76.7 | — |
| SECONDARY Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline |
-42.1; -43.2; -62.8; -65.7; -76.0; -77.0 | — |
| SECONDARY Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index) |
221; 228; 213; 225; 213; 225 | — |
| SECONDARY Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90) |
86; 89; 8; 6; 155; 173 | — |
| SECONDARY Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5 |
-1.2; -1.2; -1.8; -1.17; -2.1; -2.1 | — |
| SECONDARY The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1 |
17.1; 17.2; 39.3; 43.7; 59.1; 60.7 | — |
| SECONDARY Change in Subject's Global Assessment (SGA) of PsO |
-23.0; -24.0; -37.1; -35.0; -45.7; -45.1 | — |
| SECONDARY Change in DLQI (Dermatology Life Quality Index) |
17.9; 18.6; -12.7; -13.4; -14.3; -14.4 | — |
| SECONDARY Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) |
-0.3; -0.3; -0.2; -0.3; -0.6; -0.4 | — |
| SECONDARY Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) |
-0.4; -0.4; -0.4; -0.5; -0.6; -0.4 | — |
| SECONDARY Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L) |
11.8; 6.2; -8.9; -3.3; -9.1; -1.3 | — |
| SECONDARY The Proportion of Subjects With a Durability of Response at Week 48 |
77; 77.8; 23; 22.2 | — |
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 or 0-5),
- Body Surface Area (BSA) involved with PsO greater than or equal to 10%
- Dermatology Life Quality Index (DQLI) greater than or equal to 10
- Previously received phototherapy or systemic non-biologic therapy for PsO
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
Data sourced from ClinicalTrials.gov (NCT02134210). 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. Informational only — not medical advice.