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Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis

Primary Purpose

Sarcoidosis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
adalimumab
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is 18 years of age or older.
  • Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a physician global assessment score of at least 4. Diagnosis (based on the recommendations of an expert panel 24) can be made by either:
  • Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with no evidence of mycobacteria, fungus, or malignancy.
  • A biopsy that does not show granulomas, but the patient has characteristic skin lesions and another clinical feature suggesting sarcoidosis (bilateral hilar adenopathy, erythema nodosum, uveitis, raised ACE level, BAL lymphocytosis (CD4:CD8>3.5), panda/lambda sign on gallium scan)
  • If female of childbearing potential, subject will have a negative urine pregnancy test at Screening and Week 0.
  • If female, subject will be either post-menopausal for > 1 year, surgically sterile (hysterectomy or bilateral tubal ligation), or practicing one form of birth control (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner). Female subjects will continue to use contraception for 6 months following the last infusion.
  • Screening laboratory results are within the study parameters.
  • Subject has been on a stable dose of antibiotics, thalidomide, antimalarials, oral corticosteroids or other immunosuppressives, such cyclosporine, tacrolimus, azathioprine, methotrexate, or mycophenolate mofetil over the previous 4 weeks.

Exclusion Criteria:

  • Subject has evidence of a clinically significant, unstable or poorly controlled medical condition including unstable systemic sarcoidosis.
  • Subject has a chest X-ray consistent with an active infection or previous exposure to TB and/or a positive purified protein derivative test at screening (>5 mm).
  • Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This includes hepatitis B and C, and HIV.
  • Subject has been hospitalized for infection or received IV antibiotics within the previous 2 months prior to baseline.
  • Subject has a history of tuberculosis at anytime or close contact with a person with active tuberculosis within the previous 6 months.
  • Subject has received a live vaccination within the previous 3 months.
  • Subject has a history of a central nervous system disorder/demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
  • Subject has current signs or symptoms or history of systemic lupus erythematosus.
  • Subject has been diagnosed with a malignancy within the past 5 years except for successfully treated non-melanoma skin cancer.
  • Subject has signs or symptoms suggestive of a possible lymphoproliferative disease.
  • Subject has a diagnosis of severe congestive heart failure (Class III or IV NYHA).
  • Subject has had a substance abuse problem within the previous 3 years.
  • Subject has any dermatologic disease in the target site that may be exacerbated by treatment or interfere with examination.
  • Subject has been treated with an anti-TNF biologic immune response modifier, such as infliximab, adalimumab, or etanercept within the past 8 weeks.
  • Subject has been treated with topical corticosteroids, tacrolimus, or pimecrolimus within 2 weeks or intralesional corticosteroids within 4 weeks of baseline.
  • Subject has been administered an investigational drug in another clinical study within 30 days prior to baseline (or 5 half-lives, whichever is longer).
  • Subject has a known allergy to adalimumab.
  • Subject is female and is pregnant, is considering becoming pregnant during the study and for 6 months afterwards, or is nursing.

Sites / Locations

  • Wake Forest University Health Sciences Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

open label adalimumab 40mg

Outcomes

Primary Outcome Measures

Change in PGA score.

Secondary Outcome Measures

Number of complete responders, partial responders, minimal responders, and non-responders

Full Information

First Posted
June 2, 2008
Last Updated
November 1, 2017
Sponsor
Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT00690911
Brief Title
Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis
Official Title
A Phase II, Multi-Center, Open Label Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis (HUM 04-36)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Dr. Jorizzo has decided to withdraw from this study due to the time it is taking to get the study started.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to see if Humira is effective and safe in the treatment of sarcoidosis.
Detailed Description
The primary objective of this study is to evaluate the safety and efficacy of adalimumab for the treatment of cutaneous sarcoidosis. A secondary objective is to study gene expression in sarcoidosis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
open label adalimumab 40mg
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
Humira
Intervention Description
40mg dose subcutaneously using sterile technique. The site research staff will instruct and supervise subjects or a designee or nurse on proper injection technique during site visit evaluations. Subjects or a reliable designee will administer injectable study drug at home in between site visit evaluations.
Primary Outcome Measure Information:
Title
Change in PGA score.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Number of complete responders, partial responders, minimal responders, and non-responders
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 18 years of age or older. Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a physician global assessment score of at least 4. Diagnosis (based on the recommendations of an expert panel 24) can be made by either: Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with no evidence of mycobacteria, fungus, or malignancy. A biopsy that does not show granulomas, but the patient has characteristic skin lesions and another clinical feature suggesting sarcoidosis (bilateral hilar adenopathy, erythema nodosum, uveitis, raised ACE level, BAL lymphocytosis (CD4:CD8>3.5), panda/lambda sign on gallium scan) If female of childbearing potential, subject will have a negative urine pregnancy test at Screening and Week 0. If female, subject will be either post-menopausal for > 1 year, surgically sterile (hysterectomy or bilateral tubal ligation), or practicing one form of birth control (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner). Female subjects will continue to use contraception for 6 months following the last infusion. Screening laboratory results are within the study parameters. Subject has been on a stable dose of antibiotics, thalidomide, antimalarials, oral corticosteroids or other immunosuppressives, such cyclosporine, tacrolimus, azathioprine, methotrexate, or mycophenolate mofetil over the previous 4 weeks. Exclusion Criteria: Subject has evidence of a clinically significant, unstable or poorly controlled medical condition including unstable systemic sarcoidosis. Subject has a chest X-ray consistent with an active infection or previous exposure to TB and/or a positive purified protein derivative test at screening (>5 mm). Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This includes hepatitis B and C, and HIV. Subject has been hospitalized for infection or received IV antibiotics within the previous 2 months prior to baseline. Subject has a history of tuberculosis at anytime or close contact with a person with active tuberculosis within the previous 6 months. Subject has received a live vaccination within the previous 3 months. Subject has a history of a central nervous system disorder/demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis. Subject has current signs or symptoms or history of systemic lupus erythematosus. Subject has been diagnosed with a malignancy within the past 5 years except for successfully treated non-melanoma skin cancer. Subject has signs or symptoms suggestive of a possible lymphoproliferative disease. Subject has a diagnosis of severe congestive heart failure (Class III or IV NYHA). Subject has had a substance abuse problem within the previous 3 years. Subject has any dermatologic disease in the target site that may be exacerbated by treatment or interfere with examination. Subject has been treated with an anti-TNF biologic immune response modifier, such as infliximab, adalimumab, or etanercept within the past 8 weeks. Subject has been treated with topical corticosteroids, tacrolimus, or pimecrolimus within 2 weeks or intralesional corticosteroids within 4 weeks of baseline. Subject has been administered an investigational drug in another clinical study within 30 days prior to baseline (or 5 half-lives, whichever is longer). Subject has a known allergy to adalimumab. Subject is female and is pregnant, is considering becoming pregnant during the study and for 6 months afterwards, or is nursing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Jorizzo, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis

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