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

NCT00438360 | Completed Phase 3 Results

• 1 other identifier: COLO400CIT04
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.

Conditions

Chronic Plaque Psoriasis

Keywords

Cyclosporine, chronic plaque psoriasis, intermittent therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score

  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).

  24 weeks

Secondary Outcomes (5)

• Proportion of Participants With Clinical Relapse

  24 weeks

• Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

  baseline and week 24

• Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis

  Baseline and week 24

• Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus

  Baseline and week 24

• Safety / Tolerability Assessed by Adverse Events

  24weeks

Study Arms (2)

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

Drug: Cyclosporine A microemulsion

Placebo

PLACEBO COMPARATOR

Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Drug: Placebo

Interventions

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

Also known as: Neoral

Cyclosporine A

Placebo DRUG

Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 systemic therapy (maximum dose 5 mg/kg/day) for \>8 weeks and \<16 weeks
• PASI still \<75% of PASI before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission)

You may not qualify if:

• Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range)
• Severe chronic degenerative diseases
• Severe uncontrolled hypertension
• Body weigh \>110 kg
• Abnormal liver function
• Hyperkalemia or hyperuricemia
• Clinically significant impairment of hematopoietic and cardiovascular function
• Concomitant therapy with nephrotoxic medications
• Patients with malignancy or a history of malignancy
• Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
• Clinically significant uncontrolled bacterial, viral or fungal infection
• Evidence of drug and/or alcohol abuse

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Bari, Italy

Location

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 22, 2007
• Study Start: May 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 9, 2011
• Results First Posted: August 9, 2011

Record last verified: 2011-07

Locations

IT (1)