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Also known as Cyclosporine Microemulsion, Cyclosporine (Neoral), Cyclosporine A (CsA), Cyclosporine A microemulsion, Cyclosporine
Neoral · 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...
Neoral is used in a steroid sparing immunosuppression regimen for liver transplant recipients who have chronic hepatitis C. It is studied in this setting alongside organ transplantation and immunosuppression, with the goal of managing immunosuppression while reducing steroid exposure in patients with hepatitis C infection.
Neoral is developed and marketed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor associated with the clinical development of Neoral in the liver transplant and chronic hepatitis C setting.
Neoral has been studied in Phase 1 clinical development for chronic hepatitis C in liver transplant recipients. It is an investigational use in this setting and is not described as an approved treatment for chronic hepatitis C. The single recorded trial has completed.
Neoral was evaluated in the completed Phase 1 trial NCT00286871, titled a randomized controlled trial in liver transplant recipients treated in a steroid sparing regimen. That trial enrolled 40 participants in the United States, included adults 18 years and older of all sexes, and did not use healthy volunteers.
Yes. Neoral and Neoral® refer to the same product, with the registered trademark symbol used in the branded name. Searches for either form point to the same Novartis AG medicine studied in liver transplant recipients with chronic hepatitis C.
The Neoral trial NCT00286871 was a randomized, non-double-blind study with an uncontrolled design, enrolling 40 liver transplant recipients. Participants had chronic hepatitis C, organ transplantation, and immunosuppression, were 18 years or older, and were recruited in the United States. The trial has completed.