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Also known as Neoral
Cyclosporine A microemulsion · 2 trials · 4 indications
PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score \>75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was \>= 75%. In all the other cases the patient was considered as success (no relapse).
| Arm | Type | Description |
|---|---|---|
| Cyclosporine A | ACTIVE_COMPARATOR | Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations |
| Placebo | PLACEBO_COMPARATOR | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations |
| Name | Type | Description |
|---|---|---|
| Cyclosporine A microemulsion | DRUG | Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations |
| Placebo | DRUG | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations |
| Neoral | DRUG | - |
| Tacrolimus | DRUG | - |
Inclusion criteria: * Outpatients 18 years of age and older (max 65 years) * Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period * Disease remission obtained with only cyclosporine as syst...
Cyclosporine A microemulsion is a small molecule formulation of cyclosporine A developed by Novartis AG for the treatment of chronic plaque psoriasis. It is a microemulsion-based version of the drug designed to improve absorption. It is currently in Phase 3 clinical development for this dermatologic indication.
Cyclosporine A microemulsion is being developed for chronic plaque psoriasis, a common inflammatory skin condition. It is intended for maintenance patients with this condition. The development program is in Phase 3 and the drug is investigational, meaning it has not been approved for this use.
Cyclosporine A microemulsion targets PPIA, also known as peptidyl-prolyl cis-trans isomerase A, which is a modulator target. By binding to this target, the drug interferes with T-cell activation pathways involved in immune-mediated inflammation. This mechanism underlies its development for chronic plaque psoriasis.
Cyclosporine A microemulsion is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this microemulsion formulation for chronic plaque psoriasis.
Cyclosporine A microemulsion is in Phase 3 development for chronic plaque psoriasis. It is an investigational therapy and has not been approved by the FDA for this indication. The Phase 3 trial has been completed.
Cyclosporine A microemulsion has been studied in one completed Phase 3 trial, NCT00438360, titled Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis. The trial enrolled 243 participants in Italy, was randomized and placebo-controlled, and included adults 18 years and older of all sexes.