The Effectiveness of Lower Cyclosporine Doses for Psoriasis

NCT00377325 | Withdrawn Phase 2 DMC

• 2 other identifiers: R01AR050100NIH-7R01AR050100
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether lower doses of cyclosporine can cause fewer side effects and still produce the same beneficial results that are seen with a standard cyclosporine dose regimen when treating individuals with moderate to severe psoriasis.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Improvement in psoriasis symptoms

  Measured every 2 weeks

Study Arms (3)

1

EXPERIMENTAL

Participants will receive full dose cyclosporin.

Drug: Cyclosporine

2

EXPERIMENTAL

Participants will receive active drug full dose until cleared, then one dose every 4 days.

Drug: Cyclosporine

3

PLACEBO COMPARATOR

Participants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days.

Drug: Cyclosporine

Interventions

Cyclosporine DRUG

4 mg/Kg/day; daily; liquid form; 6 months

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Good health
• Exception that has been resistant to psoralen and ultraviolet A radiation (PUVA), methotrexate, and retinoids
• Moderate to severe, stable plaque psoriasis
• Normal organ and marrow function
• HIV uninfected

You may not qualify if:

• Topical therapy within 4 weeks of study entry
• Use of systemic, intralesional, or phototherapy within 1 year of study entry
• Use of cyclosporine in the past or use of other immunosuppressive medication within 6 months of study entry
• Inability to be followed or monitored regularly on a weekly basis
• Poorly controlled hypertension
• Severe infection, internal malignancy, immunodeficiency, gout, or liver disease
• Received more than 1,000 treatments of ultraviolet A (UVA)
• History of allergic reaction attributed to compounds of similar chemical or biological composition to cyclosporine
• Uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit study participation
• Women of childbearing potential and men unwilling to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of the study
• Pregnant

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Rochester Department of Dermatology

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Francisco Tausk, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2006
• First Posted: September 18, 2006
• Study Start: June 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

US (1)