Trial Outcomes & Findings for Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis (NCT NCT00438360)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

243 participants

Primary outcome timeframe

24 weeks

Results posted on

2011-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Cyclosporine A 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 Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Overall Study STARTED	162	81
Overall Study Intention to Treat (ITT) Population	160	79
Overall Study COMPLETED	90	38
Overall Study NOT COMPLETED	72	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Cyclosporine A 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 Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Overall Study Adverse Event	6	1
Overall Study Lack of Efficacy	42	27
Overall Study Other	24	15

Baseline Characteristics

Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclosporine A n=160 Participants 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 n=79 Participants Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.	Total n=239 Participants Total of all reporting groups
Age, Customized between 18-45 years	100 Participants n=5 Participants	48 Participants n=7 Participants	148 Participants n=5 Participants
Age, Customized Between 46 and 65 years	59 Participants n=5 Participants	29 Participants n=7 Participants	88 Participants n=5 Participants
Age, Customized >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	32 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants	47 Participants n=7 Participants	152 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Intent to treat population.

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).

Outcome measures

Outcome measures
Measure	Cyclosporine A n=160 Participants 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 n=79 Participants Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score Success at 6 months	87 Participants	36 Participants
Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score Failure at 6 months	73 Participants	43 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Intent to treat population.

Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) \>75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment.

Outcome measures

Outcome measures
Measure	Cyclosporine A n=160 Participants 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 n=79 Participants Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Proportion of Participants With Clinical Relapse	0.369 proportion of participants	0.456 proportion of participants

SECONDARY outcome

Timeframe: baseline and week 24

Population: Intention to treat (ITT) population. Patients with a value of PASI at baseline and 24 weeks were included in this analysis.

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 the severest degree.

Outcome measures

Outcome measures
Measure	Cyclosporine A n=158 Participants 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 n=76 Participants Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	5.70 Units on a scale Standard Deviation 8.0	6.86 Units on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Intent to Treat (ITT) population. Patients with a value of BSA at baseline and 24 weeks were included in this analysis.

BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( \[Height(in) x Weight(lbs) \]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed

Outcome measures

Outcome measures
Measure	Cyclosporine A n=158 Participants 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 n=76 Participants Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis	8.12 BSA (m^2) Standard Deviation 12.9	10.45 BSA (m^2) Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Intent to treat (ITT) population. Patients with a value of VAS at baseline and 24 weeks were included in this analysis.

Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).

Outcome measures

Outcome measures
Measure	Cyclosporine A n=158 Participants 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 n=76 Participants Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus	17.32 Units on a scale Standard Deviation 30.9	25.44 Units on a scale Standard Deviation 31.9

SECONDARY outcome

Timeframe: 24weeks

Outcome measures

Outcome data not reported

Adverse Events

Cyclosporine A

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cyclosporine A n=160 participants at risk 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 n=79 participants at risk Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Reproductive system and breast disorders Breast mass	0.62% 1/160 • 24 weeks Safety Population	0.00% 0/79 • 24 weeks Safety Population

Other adverse events

Other adverse events
Measure	Cyclosporine A n=160 participants at risk 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 n=79 participants at risk Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
Gastrointestinal disorders Abdominal pain upper	7.5% 12/160 • 24 weeks Safety Population	1.3% 1/79 • 24 weeks Safety Population
Metabolism and nutrition disorders Hypertriglyceridaemia	5.0% 8/160 • 24 weeks Safety Population	0.00% 0/79 • 24 weeks Safety Population

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER