Phase 4
Completed N=34
Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
Source: ClinicalTrials.gov NCT02547714 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75) — 82.4 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 This can indicate results are unpublished — a known publication-bias signal.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
The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75) |
82.4 | — |
| SECONDARY Mean Percent Change From Baseline in PASI Score |
-65.64 | — |
| SECONDARY Percentage of Participants Achieving PASI 50 or PASI 75 |
76.5; 44.1 | — |
| SECONDARY Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response |
64.7; 70.6 | — |
| SECONDARY Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score |
-63.07 | — |
| SECONDARY Percentage of Participants Achieving DLQI 0 or 1 |
76.5 | — |
Eligibility Criteria
Inclusion criteria
- Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with cyclosporine A for at least 12 weeks prior to baseline
- Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:
- PASI score of 10 or greater and
- IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)
Exclusion Criteria
- Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
- Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/L [2.0 mg/dL]) and hypertension at screening.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02547714). 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.