Erlotinib for Treatment of Psoriasis

This study has been withdrawn prior to enrollment.
(IND not obtained)
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01006096
First received: October 29, 2009
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Psoriasis
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 ]

Estimated Enrollment: 45
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006096

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

Publications:

Responsible Party: Anne E. Laumann, MBChB, MRCP (UK)/Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01006096     History of Changes
Other Study ID Numbers: MEL-041509
Study First Received: October 29, 2009
Last Updated: May 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Psoriasis
double-blind
randomized
placebo-controlled
erlotinib
efficacy

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014