Forodesine (BCX 1777) Oral Medication

The primary objective of this single agent phase two study is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of cutaneous t-cell lymphoma (CTCL) subjects, stages IIB, III, and IVA.

Eligible participants:

• Men or non-pregnant women age 18 and over.
• Confirmed diagnosis of CTCL, including mycosis fungoides and/or Sezary syndrome.
• CTCL stages IB, IIA, IIB, III or IVA at the screening visit and those who have persistent, progressive or recurrent disease and have been treated with at least three forms of systemic therapy, one of which must have been oral bexarotene or unless treatment with oral bexarotene was not tolerated or was medically contraindicated.

Principal Investigator: Ellen Kim, MD

For more information, please contact:

Marie Buchanan, RN
215-349-5699
marie.buchanan @uphs.upenn.edu

AIN457

A randomized, double-blind, placebo controlled, multi center regimen finding study of subcutaneously administered AIN457, assessing psoriasis area and severity index (PASI) response in patients with moderate to severe chronic plaque-type psoriasis. The purpose of the present study is to determine whether, in patients with moderate to severe plaque type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient’s body area is affected by the disease (compared to placebo).

Eligible participants:

• Men or women at least 18 years old at the time of consent.
• Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization.
• At randomization, moderate to severe psoriasis as defined by:
  • PASI score of 12 or greater and
  • IGA score of 3 or greater and
  • Body surface area (BSA) affected by plaque-type psoriasis of 10 percent or greater.

Principal Investigator: Joel M. Gelfand, MD, MSCE

For more information, please contact:

Deborah Leahy
215-662-6722
leahyd@uphs.upenn.edu

GDC-0449

A pivotal phase two, multi center, single arm, two cohort trial evaluating the efficacy and safety of GDC-0449 in patients with advanced basal cell carcinoma (BCC). The purpose of this study is to estimate the clinical benefit of GDC-0449 given as therapy for patients with locally advanced or metastatic BCC, as measured by overall response rate (ORR).

Eligible participants:

• Men or women age 18 or older.
• Signed informed consents.
• ECOG performance status 0, 1 or 2.

Principal Investigator: Joel M. Gelfand, MD, MSCE

For more information, please contact:

Jennifer Goldfarb, RN,CCRP
215-662-2540
jennifer.goldfarb@uphs.upenn.edu

Ustekinumab and golimumab

A phase two, multi center, randomized, double blind, parallel group, placebo controlled study evaluating the safety and efficacy of treatment with ustekinumab or golimumab in subjects with chronic sarcoidosis. The purpose of the present study is to determine whether, in patients with pulmonary or cutaneous sarcoidosis, treatment with ustekinumab or golimumab reduces disease severity (compared to placebo).

Eligible participants:

• Men or women age 18 to 85.
• Histologically proven pulmonary or skin sarcoidosis with an onset date of at least two years.
• Receive treatment with oral corticosteroids and/or one or more of the following immunomodulators: AZA, chloroquine, hydroxychloroquine, mycophenolate or leflutamide.
• Women of childbearing potential and men must be using adequate birth control measures.
• Tuberculosis (TB) screening criteria:
  • Have no history TB prior to screening
  • Have no signs or symptoms suggestive of active TB
  • Have had no recent close contact with a person with active TB
  • Have a negative QuantiFERON®-TB Gold test result.
  • Have a chest radiograph taken within two months prior to the first administration of study agent.

Principal Investigator: Misha Rosenbach, MD

For more information, please contact:

Marie Buchanan, RN
215-349-5699
marie.buchanan @uphs.upenn.edu

Hair growth prevention

A randomized, placebo-controlled clinical trial to study the safety and efficacy of a topical medication for the prevention of hair growth in healthy males over a ten week period. Participants who enroll in the research study will receive payment of $25 to $35 per visit for time and travel – up to a total of $215.

Eligible participants:

• Men age 18 or older who must shave at least once a day in order to avoid a visible beard.

Principal Investigator: Joel M. Gelfand, MD, MSCE

For more information, please contact:

Katrina Abuabara
215-746-6364
abuabark@uphs.upenn.edu