Phase 3
Completed N=431
A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
Plaque Type Psorisis
Source: ClinicalTrials.gov NCT02394561 ↗
Enrolled (actual)
431
Serious AEs
7.2%
Results posted
Apr 2019
Primary outcomePrimary: Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set) — 80.4; 81.7 percentage of 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 This can indicate results are unpublished — a known publication-bias signal.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
A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set) |
80.4; 81.7 | — |
| SECONDARY Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) |
2.2; 2.1; 0.16; 13.4; 12.1; 1.32 | — |
| SECONDARY Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) |
-8.5; -7.3; -22.4; -21.6; -38.0; -36.5 | — |
| SECONDARY Median Time to Reach PASI 90 and 75 (ITT) |
57; 58; 29; 29 | 0.1295 |
| SECONDARY Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) |
-8.5; -8.8; -8.9; -8.3 | <.0001 sig |
| SECONDARY Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) |
-1.7; -2.0; -2.5; -2.3; -1.3; -1.4 | <.0001 sig |
| SECONDARY Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) |
0.02; 0.19; 0.18; 0.21; 0.32 | — |
| SECONDARY Changes From Baseline in Body Mass Index (Safety Set) |
-0.064; -0.047; 0.086; -0.071; 0.302; -0.052 | — |
| SECONDARY Changes From Baseline in Waist Circumference (Safety Set) |
-0.86; -0.40; -0.81; -0.73; -0.76; -0.72 | — |
| SECONDARY Changes From Baseline in Weight (Safety Set) |
-0.20; -0.13; 0.24; -0.21; 0.87; -0.15 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have been able to understand and communicate with the investigator and to comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed.
- Men or women at least 18 years of age at time of screening.
- Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months (including concomitant psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis criteria [CASPAR]).
- Moderate to severe psoriasis as defined at enrollment by:
- PASI score ≥ 10 or
- PASI score > 5 but < 10 and DLQI ≥10
- Patients that are candidates for systemic therapy, whether treatment naïve or after failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these).
Exclusion criteria
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).
- Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.
- Anti-TNFα therapy within timelines depending on drug half-life.
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
- Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that was not anti-TNFα therapy.
- Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening.
- Ongoing use of corticosteroid topical treatments or UV therapy.
Data sourced from ClinicalTrials.gov (NCT02394561). 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.