A Study of Adalimumab to Treat Sarcoidosis of the Skin

NCT00274352 | Completed Phase 2

• 1 other identifier: HUM05-006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis.

Conditions

Sarcoidosis

Keywords

sarcoidosis; adalimumab; skin diseases

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects who are Responders, achieving at least Moderate Improvement on the Physician's Global Assessment, after 12 weeks of treatment during Period A (double-blind phase).

  at completion of double-blind phase (12 weeks)

Secondary Outcomes (9)

• Proportion of subjects achieving a PGA (Physician's Global Assessment) of Clear or Marked Improvement after 12 weeks of treatment during Period A.

  at completion of double-blind phase (12 weeks)

• Proportion of subjects achieving at least a PGA of Mild Improvement after 12 weeks of treatment during Period A.

  at completion of double-blind phase (12 weeks)

• Change in the patient's Quality of Life score relative to baseline after 12 weeks of treatment during Period A.

  at completion of double-blind phase (12 weeks)

• Change in the Patient's Global Assessment relative to baseline after 12 weeks of treatment during Period A.

  at completion of double-blind phase (12 weeks)

• Proportion of subjects with a 12% or greater improvement (minimum of 200mL change) in FVC and/or FEV1 after 12 weeks of treatment during Period A. (This is the minimum change thought to be clinically significant per American Thoracic Society Statement

  at completion of double-blind phase (12 weeks)

Interventions

adalimumab DRUG

Adalimumab 40 mg administered subcutaneously once weekly or placebo injection administered once weekly for 12 weeks, followed by open-label adalimumab 40 mg administered subcutaneously weekly for an additional 12 weeks.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \> 18 years of age.
• Subject must have moderate to severe cutaneous sarcoidosis with chronic indurated lesions (papules, nodules, and/or plaques), which histopathologically show non-caseating granulomas with negative special stains for microorganisms (AFB and PAS or GMS). Accepted clinical variants include, but are not necessarily limited to the following:
• lupus pernio
• nodular
• subcutaneous
• annular
• angiolupoid
• plaque
• papular
• lichenoid
• psoriasiform
• For purposes of this study "moderate to severe cutaneous sarcoidosis" is defined as the presence of sarcoidal skin lesions with any of the following features:
• At least 5 easily visible facial lesions, or
• Disease which involves \> 3% BSA, or
• Disease which confers functional impairment (e.g. nasal or visual field obstruction), or

You may not qualify if:

• Evidence of other active skin diseases or skin infections during screening that may interfere with evaluation of sarcoidosis.
• Subject has a known sensitivity to any component of the study medication. (See Table 4.)
• Subject has an active infection requiring systemic antibiotics at time of screening.
• Subject has a history of malignancy or lymphoproliferative disease within the past 5 years, excluding successfully treated non-melanoma epithelial skin cancer and/or localized carcinoma in situ of the cervix.
• Subject has a history of congestive heart failure.
• Subject has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk.
• Subject has a history of demyelinating CNS disease.
• Subject has a history of listeriosis, treated or untreated tuberculosis, exposure to individuals with tuberculosis, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, OR oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline.
• Subject is currently using or plans to use antiretroviral therapy at any time prior to or during study.
• Previous use of anti-TNF agent(s).
• Receipt of any other investigational product within 30 days prior to the first dose of investigational product.
• Subject is known to have immune deficiency or is immunocompromised.
• Female subjects who are pregnant, breast feeding, or are considering becoming pregnant during the study or within 150 days of the last dose of study medication.
• Subject has a history of clinically significant drug or alcohol abuse in the last year.
• Subject is considered by the investigator, for any reason, to be an unsuitable candidate for study participation.

Sponsors & Collaborators

• Pariser, Robert J., M.D.: lead
• Abbott: collaborator
• Virginia Clinical Research, Inc.: collaborator

Study Sites (1)

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Sarcoidosis; Skin Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Robert J Pariser, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 10, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 22, 2013

Record last verified: 2013-05

Locations

US (1)