Back to results

Erlotinib for Treatment of Psoriasis

Primary Purpose

Psoriasis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

erlotinib

placebo tablet

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, double-blind, randomized, placebo-controlled, erlotinib, efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University Feinberg School of Medicine Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Erlotinib

Placebo tablets

Arm Description

Outcomes

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).

Secondary Outcome Measures

To determine the rate of dose reduction or interruption as a result of adverse events.

To determine quality of life using the Dermatology Life Quality Index (DLQI).

Full Information

NCT ID

NCT01006096

First Posted

October 29, 2009

Last Updated

November 7, 2014

Sponsor

Northwestern University

Collaborators

OSI Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01006096

Brief Title

Erlotinib for Treatment of Psoriasis

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Withdrawn

Why Stopped

IND not obtained

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Northwestern University

Collaborators

OSI Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis, double-blind, randomized, placebo-controlled, erlotinib, efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erlotinib

Arm Type

Experimental

Arm Title

Placebo tablets

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

100mg tablet, once daily for 16 weeks

Intervention Type

Other

Intervention Name(s)

placebo tablet

Intervention Description

placebo tablet (lactose), once daily for 16 weeks

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To determine the rate of dose reduction or interruption as a result of adverse events.

Time Frame

week 4, 8, 12, 16, and 24

Title

To determine quality of life using the Dermatology Life Quality Index (DLQI).

Time Frame

week 4, 8, 12, 16, and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne E Laumann, MBChB, MRCP (UK)

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine Department of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17314973

Citation

Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.

Results Reference

background

PubMed Identifier

16014882

Citation

Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.

Results Reference

background

PubMed Identifier

16990857

Citation

Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970.

Results Reference

background

PubMed Identifier

16792781

Citation

Wierzbicka E, Tourani JM, Guillet G. Improvement of psoriasis and cutaneous side-effects during tyrosine kinase inhibitor therapy for renal metastatic adenocarcinoma. A role for epidermal growth factor receptor (EGFR) inhibitors in psoriasis? Br J Dermatol. 2006 Jul;155(1):213-4. doi: 10.1111/j.1365-2133.2006.07299.x. No abstract available.

Results Reference

background

PubMed Identifier

7640880

Citation

Ben-Bassat H, Vardi DV, Gazit A, Klaus SN, Chaouat M, Hartzstark Z, Levitzki A. Tyrphostins suppress the growth of psoriatic keratinocytes. Exp Dermatol. 1995 Apr;4(2):82-8. doi: 10.1111/j.1600-0625.1995.tb00227.x.

Results Reference

background

PubMed Identifier

10583160

Citation

Powell TJ, Ben-Bassat H, Klein BY, Chen H, Shenoy N, McCollough J, Narog B, Gazit A, Harzstark Z, Chaouat M, Levitzki R, Tang C, McMahon J, Shawver L, Levitzki A. Growth inhibition of psoriatic keratinocytes by quinazoline tyrosine kinase inhibitors. Br J Dermatol. 1999 Nov;141(5):802-10. doi: 10.1046/j.1365-2133.1999.03152.x.

Results Reference

background

PubMed Identifier

10828317

Citation

Ben-Bassat H, Klein BY. Inhibitors of tyrosine kinases in the treatment of psoriasis. Curr Pharm Des. 2000 Jun;6(9):933-42. doi: 10.2174/1381612003400182.

Results Reference

background

PubMed Identifier

10909421

Citation

Ben-Bassat H, Levitzki A. Inhibitors of tyrosine kinases in the treatment of psoriasis. Isr Med Assoc J. 2000 Jul;2 Suppl:69-73. No abstract available.

Results Reference

background

PubMed Identifier

18535184

Citation

Halin C, Fahrngruber H, Meingassner JG, Bold G, Littlewood-Evans A, Stuetz A, Detmar M. Inhibition of chronic and acute skin inflammation by treatment with a vascular endothelial growth factor receptor tyrosine kinase inhibitor. Am J Pathol. 2008 Jul;173(1):265-77. doi: 10.2353/ajpath.2008.071074. Epub 2008 Jun 5.

Results Reference

background

PubMed Identifier

18446355

Citation

Forsberg S, Ostman A, Rollman O. Regeneration of human epidermis on acellular dermis is impeded by small-molecule inhibitors of EGF receptor tyrosine kinase. Arch Dermatol Res. 2008 Oct;300(9):505-16. doi: 10.1007/s00403-008-0853-2. Epub 2008 Apr 30.

Results Reference

background

PubMed Identifier

18769609

Citation

Neyns B, Meert V, Vandenbroucke F. Cetuximab treatment in a patient with metastatic colorectal cancer and psoriasis. Curr Oncol. 2008 Aug;15(4):196-7. doi: 10.3747/co.v15i4.228.

Results Reference

background

PubMed Identifier

15370619

Citation

Trivin F, Boucher E, Raoul JL. Complete sustained regression of extensive psoriasis with cetuximab combination chemotherapy. Acta Oncol. 2004;43(6):592-3. doi: 10.1080/02841860410020211. No abstract available.

Results Reference

background

Learn more about this trial

Erlotinib for Treatment of Psoriasis

We'll reach out to this number within 24 hrs