Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

Inclusion Criteria:

- Male and female patients,18 to 65 years of age inclusive, who have been defined as
having SCLE based on the typical clinical picture and the characteristic
histopathological features as described by Sontheimer et al. at least three months
before study entry (screening)

Exclusion Criteria:

1. Patients with preexisting nephritis, central nervous or pulmonary involvement or any
major internal organ damage, either related or unrelated to lupus, which are deemed
by the Investigator to be clinically significant. Patients having signs or symptoms
of other autoimmune diseases such as systemic lupus erythematosus or Sjogren`s
syndrome are allowed to enter the study at the Investigator`s discretion.

2. Patients who have been treated with:

- immunoglobulins and/or monoclonal antibodies within 6 months prior to
randomization.

- rituximab, cyclophosphamide, or other immunosuppressive treatments with effects
potentially lasting over 6 months, within 12 months prior to randomization.

- a medium or high dose (≥ 1 mg prednisone or equivalent per body weight kg)
corticosteroid therapy in the last 8 weeks prior to randomization.

- antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last
6 weeks prior to randomization.

- biologic therapies, such as etanercept, within the last 4 weeks prior to
randomization.

- any other immunosuppressive or immunomodulatory therapy such as methotrexate,
azathioprine, cyclosporin A or mycophenolate, thalidomide, retinoids or dapsone
in the last 4 weeks prior to randomization.

- total lymphoid irradiation or bone marrow transplantation.

3. Pregnant, planning to get pregnant, and/or lactating females or males planning to
father a child within time period of the study or subsequent exclusionary period.

Other protocol-defined inclusion/exclusion criteria may apply