Overview
A Study of Adalimumab to Treat Sarcoidosis of the Skin
Status:
Completed
Completed
Trial end date:
2012-02-01
2012-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Pariser, Robert J., M.D.Collaborators:
Abbott
Virginia Clinical Research, Inc.Treatments:
Adalimumab
Criteria
Inclusion Criteria:1. Subject is > 18 years of age.
2. 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
3. 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
- Disease which confers significant symptoms of itching and/or pain.
4. If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy), or is using one of the following methods of birth
control for the duration of the study and 90 days after study completion:
- condoms, sponge, foams, jellies, diaphragm, or intrauterine device
- contraceptives (oral or parenteral) for three months prior to study drug
administration
- a vasectomized sole partner
5. Females of childbearing potential must have a negative serum pregnancy test at
screening visit.
6. Subject must have no history of nor evidence of tuberculosis, either active or
previously treated. This determination will be based on a negative PPD skin test and
negative chest radiograph at screening, negative history of previous tuberculosis, and
negative history of previous exposure to tuberculosis.
7. Subject must be willing and able to give informed consent and to comply with the
requirements of the protocol.
8. Subject must be willing and able to self-administer SC injections or to have a
qualified person available to administer SC injections.
9. The following criteria for concomitant treatments of sarcoidosis must be met:
- Topical therapies (corticosteroids) must be discontinued at least 2 weeks prior
to baseline visit.
- Intralesional therapies (corticosteroids) must be discontinued at least 4 weeks
prior to baseline visit.
- Systemic therapies (MTX, antimalarials, prednisone, immunosuppressants,
thalidomide, tetracycline derivatives) must be discontinued at least 4 weeks
prior to baseline visit.
OR if a subject is on such topical or oral medications, the dose has been stable for these
same time intervals and is likely to remain stable for the duration of the study. Patients
whose non-cutaneous disease is being managed by other physicians will continue to have
their care directed by these physicians. The managing physicians will be kept informed of
the patients' status, consistent with study blinding. If the patient's dose of a
concomitant systemic therapy for non-cutaneous sarcoidosis must change by more than 20% of
the dose at study entry due to a change in medical condition during the double-blind phase,
the subject will be discontinued from the study. During the open-label phase the need for a
greater than 20% increase in dose of concomitant treatment for non-cutaneous sarcoidosis
will be viewed as treatment failure and the patient will be discontinued from the study.
Reduction of the dose of such treatment of any magnitude will not result in discontinuance.
Continued use of intralesional therapies is not permitted. Inhaled corticosteroids for a
stable medical condition are allowed.
Exclusion Criteria:
1. Evidence of other active skin diseases or skin infections during screening that may
interfere with evaluation of sarcoidosis.
2. Subject has a known sensitivity to any component of the study medication. (See Table
4.)
3. Subject has an active infection requiring systemic antibiotics at time of screening.
4. 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.
5. Subject has a history of congestive heart failure.
6. 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.
7. Subject has a history of demyelinating CNS disease.
8. 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.
9. Subject is currently using or plans to use antiretroviral therapy at any time prior to
or during study.
10. Previous use of anti-TNF agent(s).
11. Receipt of any other investigational product within 30 days prior to the first dose of
investigational product.
12. Subject is known to have immune deficiency or is immunocompromised.
13. 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.
14. Subject has a history of clinically significant drug or alcohol abuse in the last
year.
15. Subject is considered by the investigator, for any reason, to be an unsuitable
candidate for study participation.
16. Clinically significant ECG abnormalities at screening visit.
17. Hgb < 8.5 g/dL in females and < 9.0 in males.
18. WBC count < 3000/mm2
19. AST or ALT > 2.0 times the upper limit of normal for the age range, confirmed by a
repeat measure.
20. Bilirubin > 3mg/dL
21. Creatinine > 1.6 mg/dL in women, and > 1.8 mg/dL in men.
22. Subject plans to receive any live vaccines during the study.
23. Subject has a variant of sarcoidosis that is not amenable to study evaluation, in the
absence of chronic indurated lesions, such as:
- Acute, "benign" sarcoid associated with erythema nodosum
- Acute iritis
- Ichthyosiform sarcoidosis
- Hypo- or hyperpigmented macular sarcoidosis
- Ulcerative sarcoidosis
- Erythroderma
- Alopecia