NCT00109317

CompletedPhase 3

A Study to Evaluate Raptiva in Adults With Moderate to Sever...

Genentech, Inc.Source

Genentech, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

ACD2600g

Study Type

interventional

Actual enrollment (reported)

686

Locations

0 countries

Sites

N/A

Timeline

Study Start

September 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

February 2003

Actual (reported)

Brief Summary

This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Registry Overview

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

Recruitment status: completed
Actual enrollment (reported): 686 participants
Study completion date: February 2003
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

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

Study Start
September 2002
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
February 2003
Actual (reported)
First Submitted
April 27, 2005
Actual (reported)
First Posted
April 27, 2005
Actual (reported)

Last Updated: June 21, 2013
Status Verified: June 2013
Last Update Submitted: June 19, 2013

Conditions

Psoriasis

Keywords

Moderate Plaque PsoriasisSevere Plaque PsoriasisTopical

Interventions

Raptiva (efalizumab)Drug

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

Enrollment

686 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 27, 2005

First Posted

April 27, 2005

Study Start

September 2002

Date type not reported

This date has not been verified as actual or estimated.

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

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

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

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

Diagnosis of plaque psoriasis for at least 6 months

Minimal PASI score of 12.0 at screening

In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)

Body weight of \<=140 kg

to 75 years old

For women of childbearing potential, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study

Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study

Willingness to enter Study ACD2601g

You may not qualify if:

Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region
Clinically significant psoriasis flare during screening or on the day of randomization
History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
History of opportunistic infections (e.g., systemic fungal infections, parasites)
Seropositivity for human immunodeficiency virus (HIV)
Pregnancy or lactation
WBC count \<4000/uL or \>14,000/uL
Seropositivity for hepatitis B or C virus
Hepatic enzymes \>=3x the upper limits of normal (ULN)
History of active tuberculosis (TB) or currently undergoing treatment for TB
Presence 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
Serum creatinine \>=2x the ULN
+3 more criteria

Contact the study team to confirm eligibility.

Study Completion

February 2003

Actual (reported)

Last Updated

June 21, 2013

Record last verified: 2013-06

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: NCT00109317
Data provider: ClinicalTrials.gov
Source updated: 2013-06-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:19 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)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record