Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

Novartis

Status and phase: Completed; Phase 2

Conditions: Subacute Cutaneous Lupus Erythematosus

Treatments: Drug: Placebo to KRP203 - 1.2 mg; Drug: KRP203 - 1.2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294774

CKRP203A2202

2010-019689-10 (EudraCT Number)

Details and patient eligibility

About

This study will assess the safety and efficacy of KRP203 in clinically active subacute cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard treatment, such as antimalarials.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

10 participants in 2 patient groups, including a placebo group

KRP203 - 1.2 mg

Experimental group

Treatment:

Drug: KRP203 - 1.2mg

Placebo to KRP203 - 1.2 mg

Placebo Comparator group

Treatment:

Drug: Placebo to KRP203 - 1.2 mg