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Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis

Information source: Amgen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: NB-UVB (Device); Etanerept (Drug); Etanercept (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen


The purpose of this study is to evaluate the safety and effectiveness of combination therapy with etanercept and narrow-band (NB) UVB phototherapy for the treatment of psoriasis in a pilot study. This is a Phase 4 clinical study being conducted under an Amgen Investigational New Drug Application (IND).

Clinical Details

Official title: A Multicenter, Open-Label, Pilot Trial to Evaluate the Effectiveness and Safety of ENBREL(r) in Combination With Narrowband UVB Phototherapy for the Treatment of Psoriasis

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12

Secondary outcome:

Time to PASI 75 responses

Proportion of subjects achieving PASI 90 at Week 12

Improvement in PASI at Week 12

Improvement in body surface area (BSA) involved with psoriasis at Week 12

Improvement in physician global assesssment of psoriasis, including an assessment of the proportion of subjects achieving clear or almost clear status at Week 12

Improvement in patient global assesssment of psoriasis at Week 12

Improvement in Dermatology Life Quality Index (DLQI) at Week 12

Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: - Chronic plaque psoriasis eligible for systemic therapy and NB-UVB in

the opinion of the investigator - Psoriasis Activity and Severity Index (PASI) greater

than or equal to 15 and at least 25% of individual plaques must be considered severe -

Patients must have body surface area (BSA) involvement of greater than or equal to 5% -

Before any study-specific procedure, subject must sign and date the appropriate written

informed consent - Negative urine pregnancy test within 7 days before the first dose of

study drug in all women (except those surgically sterile or at least 5 years

postmenopausal) - Sexually active subjects of childbearing potential must agree to use

medically acceptable form of contraception during screening and throughout the study

Exclusion Criteria: - Prior phototherapy - Current or prior treatment with any tumor

necrosis factor (TNF) antagonist, including etanercept, infliximab and adalimumab -

Erythrodermic, pustular or guttate psoriasis - Evidence of skin conditions (e. g., eczema)

other than psoriasis that would interfere with study-related evaluations of psoriasis -

Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit or between the

screening and baseline visits - History of immune compromised health [e. g., human

immunodeficiency virus (HIV) positive status] - History of any cutaneous malignancy at any

time, including squamous or basal cell carcinomas or melanoma - History of non-cutaneous

cancer within 5 years - Actinic keratosis or atypical moles - History of alcohol or drug

abuse within 12 months of screening visit - Current enrollment in another clinical study

and treatment with another experimental drug or approved therapy for experimental use

within 30 days prior to etanercept administration - Severe comorbidities as outlined in

ENBREL(r) Package Insert: diabetes mellitus requiring insulin, congestive heart failure of any severity, myocardial infarction (within less than or equal to 52 weeks before screening), unstable angina pectoris, oxygen-dependent severe pulmonary disease, tuberculosis or tuberculosis exposure, chronic hepatitis B or hepatitis C, systemic lupus erythematosus, history of multiple sclerosis or other demyelinating disease, transverse myelitis, optic neuritis or epilepsy, uncontrolled hypertension (defined as systolic blood

pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg) -

Contraindications according to the ENBREL(r) Package Insert - Evidence of open cutaneous

ulcers - Evidence of photosensitivity disorder (e. g., polymorphous light eruption) -

Nursing mothers, female subjects planning on becoming pregnant or male subjects planning a

pregnancy with their spouse/partner while in the study - Subjects that cannot commit to

all the assessments required by the protocol - Known photosensitivity or known sensitivity

to any of the excipients or products to be administered during dosing - Any disorder that

compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

FDA-approved Drug Labeling

Starting date: March 2005
Last updated: May 22, 2013

Page last updated: August 20, 2015

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