Erlotinib for Treatment of Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006096
Recruitment Status : Withdrawn (IND not obtained)
First Posted : November 2, 2009
Last Update Posted : November 10, 2014
OSI Pharmaceuticals
Information provided by:
Northwestern University

Brief Summary:
The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: erlotinib Other: placebo tablet Phase 2

Detailed Description:
Psoriasis vulgaris is a disease that affects 25 million people in North America and Europe. It often presents in late adolescence and usually persists for life. Current therapies target specific immune molecules that are implicated in the cause of this disease. For example, biologic agents that are used in severe psoriasis are aimed at inflammatory mediators. These therapies have been proven to be effective but also have their limitations.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-blind, Placebo-controlled, Two-arm Study to Evaluate the Safety and Efficacy of Erlotinib in the Treatment of Moderate to Severe Psoriasis

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Erlotinib Drug: erlotinib
100mg tablet, once daily for 16 weeks
Other Name: Tarceva

Placebo Comparator: Placebo tablets Other: placebo tablet
placebo tablet (lactose), once daily for 16 weeks

Primary Outcome Measures :
  1. To determine efficacy of erlotinib in treatment of moderate to severe psoriasis measured by the Psoriasis Area and Severity Index (PASI) and the Physician's Global Assessment (PGA). [ Time Frame: week 4, 8, 12, 16, and 24 ]

Secondary Outcome Measures :
  1. To determine the rate of dose reduction or interruption as a result of adverse events. [ Time Frame: week 4, 8, 12, 16, and 24 ]
  2. To determine quality of life using the Dermatology Life Quality Index (DLQI). [ Time Frame: week 4, 8, 12, 16, and 24 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe psoriasis
  • Must have documented moderate to severe psoriasis by the Physician's Global Assessment (PGA) and the Psoriasis Area Severity Index (PASI)
  • Must be able to swallow tablets
  • Must be able to provide written informed consent
  • Subjects with reproductive potential (menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study and thirty days after discontinuation of study drug. Women of childbearing potential must provide negative pregnancy test (serum or urine) within 14 days prior to randomization.

Exclusion Criteria:

  • Use of concurrent agents/therapies for psoriasis
  • Bilirubin > 3 X ≥ ULN or moderate to severe hepatic impairment
  • Pregnant or breast-feeding females
  • Subjects currently receiving other anticancer treatments
  • Subjects currently receiving other biologic treatments
  • Subjects currently receiving blood thinners (warfarin or heparin)
  • Subjects who currently smoke
  • Subjects with other skin disease which in the opinion of the investigator, would inhibit the ability to use the PGA and PASI evaluation methods

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006096

United States, Illinois
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
OSI Pharmaceuticals
Principal Investigator: Anne E Laumann, MBChB, MRCP (UK) Northwestern University


Responsible Party: Anne E. Laumann, MBChB, MRCP (UK)/Associate Professor, Northwestern University Identifier: NCT01006096     History of Changes
Other Study ID Numbers: MEL-041509
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014

Keywords provided by Northwestern University:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action