Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus

NCT00285779 | Terminated Phase 2 Results DMC

• 1 other identifier: 20041132
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose is to assess the response of subjects to etanercept (as compared to placebo) in treating the physical signs of mucosal and cutaneous lichen planus. The investigators also wish to assess the effect of etanercept on disease-related itching, pain, and serious adverse events in patients with lichen planus.

Conditions

Lichen Planus

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks

  Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level \>=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.

  12 weeks

Secondary Outcomes (14)

• Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks

  Baseline; Week 24

• The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks

  Baseline; Week 12; Week 24

• The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks

  Baseline; Week 12; Week 24

• The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks

  Baseline; Week 12; Week 24

• Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks

  Week 12; Week 24

Study Arms (2)

Placebo injection

PLACEBO COMPARATOR

patients receive normal saline injection twice weekly for weeks 1-12

Drug: Placebo

Etanercept

EXPERIMENTAL

patients receive etanercept injection twice weekly for weeks 1-12.

Drug: Etanercept

Interventions

Etanercept DRUG

etanercept 50 mg twice weekly for 12 weeks

Also known as: Enbrel

Etanercept

Placebo DRUG

Placebo injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• Must carry a diagnosis of lichen planus as determined by biopsy
• Patients must have a score of 3 or greater on the physician global assessment (PGA).
• Patient must be considered appropriate for systemic therapy based upon fulfilling one of the following criteria:
• inability to maintain weight due to pain with eating, chewing, or swallowing;
• dyspareunia or dysuria due to genital lesions;
• itch/pain of sufficient severity that activities of daily living are significantly affected
• Must be off systemic lichen planus treatment for 4 weeks prior to starting etanercept
• If using topical corticosteroid to the affected areas, the dose and frequency must be unchanged for 2 weeks prior to beginning the study agent and during the course of the study.
• Must be off topical cyclosporine, tacrolimus, or pimecrolimus for 2 weeks prior to starting the study drug and for the entire duration of the study.
• Must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information.
• Women of childbearing potential must have a negative pregnancy test at the time of entry into the study and must be practicing successful contraception for at least 3 months prior to the study.
• Subject or designee must have the ability to self-inject investigational product.
• Screening laboratory results are within the following parameters:
• Hemoglobin \> 10 g/dL

You may not qualify if:

• Subject is currently enrolled in another investigational device or drug trial(s), or subject has received investigational agent(s) within 90 days of baseline visit.
• Known HIV-positive status, any other immuno-suppressive disease, or inability to practice safe sex during the length of the study
• Subject has been diagnosed with a malignancy within the past 5 years
• Subject has signs or symptoms of a lymphoproliferative disease.
• Other skin or mucosal disease that might interfere with lichen planus assessments.
• Lichen planus variants including hypertrophic, atrophic, follicular (including lichen planopilaris), and bullous cutaneous forms.
• Patients with lichen sclerosis et atrophicus (LS\&A)
• Clinical history and lesion distribution suspicious for a lichenoid drug eruption
• Severe co-morbidities
• History of tuberculosis (TB) or positive PPD at screening. Known history of active hepatitis B or C, or lupus, SLE, history of multiple sclerosis or prior episode of central nervous system demyelination, transverse myelitis, optic neuritis, epilepsy, psychiatric condition, or other chronic serious medical illnesses.
• Subject has a diagnosis of congestive heart failure (CHF) of any severity
• Use of a live vaccine 90 days prior to, or during this study.
• Previous exposure and/or known sensitivity to etanercept
• Concurrent use, or failure of, any TNF-inhibitor
• Previous exposure to alefacept or efalizumab within 6 weeks of administration of study drug

Sponsors & Collaborators

• Stanford University: lead
• Wright State University: collaborator
• Tufts Medical Center: collaborator
• University of Louisville: collaborator
• Wake Forest University Health Sciences: collaborator
• University of Michigan: collaborator
• Emory University: collaborator
• University Hospitals Cleveland Medical Center: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Oregon Health and Science University: collaborator
• The Cleveland Clinic: collaborator
• Fivenson, David, M.D.: collaborator

Study Sites (12)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

David Fivenson, M.D. Dermatology, PLLC

Ann Arbor, Michigan, 48103, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 26157, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Wright State University School of Medicine

Dayton, Ohio, 45408, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Lichen Planus

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

Trial was terminated early due to low recruitment rates.

Results Point of Contact

• Title: David Fiorentino
• Organization: Stanford University Department of Dermatology

fiorentino@stanford.edu

650-723-6316

Study Officials

• David F Fiorentino, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• David F Fiorentino, MD, PhD

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: August 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 21, 2018
• Results First Posted: March 3, 2015

Record last verified: 2018-03

Locations

US (12)