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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00690911
• Date of registration: 02/06/2008
• Prospective Registration: No
• Primary sponsor: Wake Forest University
• Public title: Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis
• Scientific title: A Phase II, Multi-Center, Open Label Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis (HUM 04-36)
• Date of first enrolment: August 2007
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00690911
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Joseph Jorizzo, MD
• Affiliation: Wake Forest University Health Sciences

Key inclusion & exclusion 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.



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

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: adalimumab

Primary Outcome(s)

Change in PGA score. [Time Frame: 24 weeks]

Secondary Outcome(s)

Number of complete responders, partial responders, minimal responders, and non-responders [Time Frame: 24 weeks]

Secondary ID(s)

00002161

32409

Source(s) of Monetary Support

Please refer to primary and secondary sponsors