Erlotinib for Treatment of Psoriasis

This study has been withdrawn prior to enrollment.
(IND not obtained)
OSI Pharmaceuticals
Information provided by:
Northwestern University Identifier:
First received: October 29, 2009
Last updated: November 7, 2014
Last verified: November 2014
The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.

Condition Intervention Phase
Drug: erlotinib
Other: placebo tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 NLM:

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the rate of dose reduction or interruption as a result of adverse events. [ Time Frame: week 4, 8, 12, 16, and 24 ] [ Designated as safety issue: Yes ]
  • To determine quality of life using the Dermatology Life Quality Index (DLQI). [ Time Frame: week 4, 8, 12, 16, and 24 ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information


Responsible Party: Anne E. Laumann, MBChB, MRCP (UK)/Associate Professor, Northwestern University Identifier: NCT01006096     History of Changes
Other Study ID Numbers: MEL-041509 
Study First Received: October 29, 2009
Last Updated: November 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Papulosquamous
Erlotinib Hydrochloride
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 26, 2016