NCT00338143

CompletedPhase 3

A Study to Evaluate Efalizumab in Adults With Plaque Psorias...

Genentech, Inc.Source

Genentech, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

ACD2782g

Study Type

interventional

Reported enrollment (type unavailable)

1,200

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

May 2004

Actual (reported)

Brief Summary

This is a Phase IIIb, open label, uncontrolled, multicenter study designed to evaluate the safety and tolerability of 12 weeks of subcutaneously administered efalizumab in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy and may also be receiving topical therapies, PUVA, or UVB phototherapy during the efalizumab treatment period.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 1,200 participants
Study completion date: May 2004
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2003
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
May 2004
Actual (reported)
First Submitted
June 15, 2006
Actual (reported)
First Posted
June 20, 2006
Actual (reported)

Last Updated: March 4, 2014
Status Verified: February 2014
Last Update Submitted: February 28, 2014

Conditions

Psoriasis

Keywords

Plaque psoriasisAntipsoriatic

Interventions

efalizumabDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed informed consent
Plaque psoriasis covering \>=10% of total BSA

Sponsors & Collaborators

Genentech, Inc.
Industrylead

MeSH Terms

Conditions

Psoriasis

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Ivor Caro, M.D.
Genentech, Inc.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Purpose: TREATMENT
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

October 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

May 2004

Actual (reported)

NCT00096980

A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies

Phase 4Completed

NCT00312026

A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet

Phase 4Completed

NCT00669214

A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp

Phase 4Completed

NCT00336973

A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent

Phase 4Completed

NCT00237887

Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3Completed

NCT00111436

Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

Phase 3Completed

Plaque psoriasis diagnosed for at least 6 months

In the opinion of the investigator, a candidate for systemic therapy for psoriasis

years old

Body weight \<=125 kg

For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 3 months after the last dose of efalizumab

You may not qualify if:

Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
Pregnancy or lactation
Clinically significant psoriasis flare during screening or at the time of enrollment
History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
History of opportunistic infections (e.g., systemic fungal infections, parasites)
Seropositivity for hepatitis B or C virus
Seropositivity for human immunodeficiency virus (HIV)
History of active tuberculosis (TB) or currently undergoing treatment for TB
Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
Previous treatment with efalizumab (anti-CD11a)
Diagnosis of hepatic cirrhosis, regardless of cause or severity
Hospital admission for cardiovascular or pulmonary disease within the last year
History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an Ig Fc region (e.g., etanercept, alefacept)
History of treatment with lymphocyte-depleting monoclonal antibodies or immunoadhesion molecules (e.g., anti-CD4, CTLA4-Ig, alefacept)
White blood cell (WBC) count \< 4000/uL or \> 14,000/uL
+6 more criteria

Contact the study team to confirm eligibility.

Last Updated

March 4, 2014

Record last verified: 2014-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00338143
Data provider: ClinicalTrials.gov
Source updated: 2014-03-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:21 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record