A multi-center, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy and tolerability of KRP203 in patients with active subacute cutaneous lupus erythematosus

• Conditions: Subacute cutaneous lupus erythematosus, in patients who do not respond to first line therapies (i.e. antimalarials); MedDRA version: 12.1Level: HLTClassification code 10025135Term: Lupus erythematosus (incl subtypes)

• Registration Number: EUCTR2010-019689-10-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-10
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Male and female patients between 18-65 (inclusive) years of age who have been defined as having SCLE based on the typical clinical picture and the characteristic histopathological features as described by Sontheimer et al (see Section 6.2) at least three months before study entry (screening). The patients must demonstrate moderate to severe active skin disease at baseline by having an activity score of CLASI = 6, with at least 2 points in at least 3 different anatomical locations for erythema or scale/hypertrophy. Patients must have failed systemic therapy such as a full dose of an antimalarial agent (hydroxychloroquine, chloroquine or quinacrine) or a combination of lower doses of antimalarials, prior to screening. A failed response is considered to be one or more of the following: a. inadequate clinical response after at least 12 weeks of therapy; b. loss of clinical response to antimalarial therapy; c. toxicity in response to antimalarial therapy that required discontinuation of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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. Patients who have been treated with: a. immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization. b. rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization. c. a medium or high dose (= 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization. d. antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization. e. biologic therapies, such as etanercept, within the last 4 weeks prior to randomization. f. 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. g. total lymphoid irradiation or bone marrow transplantation. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified