Trial of Antimycobacterial Therapy in Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01074554
• Date of registration: 08/02/2010
• Prospective Registration: No
• Primary sponsor: Vanderbilt University
• Public title: Trial of Antimycobacterial Therapy in Sarcoidosis CLEAR
• Scientific title: Phase I/II Study of the Effects of Antibiotics on Sarcoidosis Pathogenesis
• Date of first enrolment: February 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01074554
• Study type: Interventional
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Wonder P Drake, MD
• Affiliation: Vanerbilt University School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as
defined by the clinical presentation consistent with sarcoidosis, biopsy finding
granulomas, and no alternative for the cause of the granulomas, such as tuberculosis

2. Patients must have chronic cutaneous skin lesions with or without taking chronic
therapy (corticosteroids, methotrexate (max 10mg/week), azathioprine,
hydroxychloroquine, cyclophosphamide, minocycline, doxycycline and chloroquine), in
which the dose has not been altered in the 2 months prior to starting the study.

3. Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a
Sarcoidosis Activity and Severity Index assessment score of at least 4. Diagnosis 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 history of clinical features suggesting sarcoidosis (previous biopsy
revealing noncaseating granuloma, bilateral hilar adenopathy, erythema nodosum,
uveitis, raised ACE level, BAL lymphocytosis (CD4:CD8>3.5), panda/lambda sign on
gallium scan)

- 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

- 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

- Females of childbearing potential must have a negative serum pregnancy test at
screening visit.

Exclusion Criteria:

1. No consent/inability to obtain consent.

2. Age less than 18 years of age.

3. Inability to obtain biopsy or draw blood.

4. CPK, ALT or AST >5 times upper limit of normal (ULN)

5. Pregnancy or breast feeding.

6. Current use of medications metabolized by rifampin (See Appendix).

7. Allergy to macrolides, quinolones or rifamycins.

8. Visual Impairment as defined by differentiating colors.

9. Family or personal history of long QT syndromes.

10. Patients receiving another interventional investigational drug within the 30 days
prior to dosing

11. Use of any investigational medication within the past 28 days prior to study
enrollment.

12. Subject has been hospitalized for infection or received IV antibiotics within the
previous 2 months prior to baseline.

13. Subject has a history of tuberculosis at anytime or close contact with a person with
active tuberculosis within the previous 6 months, or 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.

14. Evidence of other active skin diseases or skin infections during screening that may
interfere with evaluation of sarcoidosis.

15. Subject has an active infection requiring systemic antibiotics at time of screening

16. Subject has a history of listeriosis, treated or untreated tuberculosis, exposure to
individuals with tuberculosis.

17. 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

18. Patients otherwise unsuitable for participation in the opinion of the investigator



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: Placebo Regimen

Drug: Antibiotic Regimen

Primary Outcome(s)

Change in Lesion Size at the Completion of Antibiotic Therapy, Measured on a Continuous Scale; Change Will be Determined by Change in Diameter of the Lesions [Time Frame: Baseline to 8 weeks]

Granuloma Burden [Time Frame: Baseline to 8 weeks]

Secondary Outcome(s)

Change in Modified Sarcoidosis Activity and Severity Index (SASI) at Completion of Therapy. [Time Frame: Baseline to 8 weeks]

Secondary ID(s)

091103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/10/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01074554