A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab Followed by Efalizumab Taper in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00109252

Enrollment

Registered

2005-04-26

Start date

2002-01-31

Completion date

2003-04-30

Last updated

2013-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Plaque Psoriasis, Topical

Brief summary

This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.

Interventions

DRUGRaptiva (efalizumab)

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Signed informed consent * Previous participation in Study ACD2390g * For women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study * Willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources throughout the study

Exclusion criteria

* Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab * Systemic therapy for psoriasis (ET Day 0 through FU Day 84 or upon relapse or unusual presentation of psoriasis in the FU period, whichever occurs first) * Systemic immunosuppressive drugs for other indications (ET Day 0 through FU Day 84) * Topical therapies for psoriasis (ET Day 0 through ET Day 84) * Live virus or bacteria vaccines (ET Day 0 through FU Day 84) * Other vaccines or allergy desensitization (it is recommended that these be scheduled after FU Day 84) * Other experimental drugs or treatments (ET Day 0 through FU Day 84) * Beta-Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between ET Day 0 and TT Day 84)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026