Study to assess the safety and efficacy of KRP203 in active subacute cutaneous lupus erythematosus patients, who have shown poor response to standard treatment.

• Conditions: Subacute cutaneous lupus erythematosus, in patients who do not respond to first line therapies (i.e. antimalrials); MedDRA version: 14.0Level: HLTClassification code 10025135Term: Lupus erythematosus (incl subtypes)System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-06
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

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

Inclusion Criteria

- Male and female (non-pregnant, non-lactating female)patients between 18-65 years of age. Having SCLE as described by Sontheimer et al (see Section 6.2) for at least 3 months before screening.

- Moderate to severe active skin disease at baseline by having an activity score of CLASI ³ 6, has to be demontrated, with at least 2 points in at least 3 different anatomical locations for erythema or scale/hypertrophy.

Other protocol-defined inclusion criteria may apply

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 24
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. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren`s syndrome are allowed to enter the study
- 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 exclusion criteria may apply.

Study & Design

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