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

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2010-019689-10-DE
• Date of registration: 10/08/2010
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 20/09/2010
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019689-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Greece, Italy

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Product Name: KRP203
Product Code: KRP203
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not established
CAS Number: 509088-69-1
Current Sponsor code: KRP203
Other descriptive name: KRP203-AAA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: KRP203
Product Code: KRP203
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not established
CAS Number: 509088-69-1
Current Sponsor code: KRP203
Other descriptive name: KRP203-AAA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: KRP203
Product Code: KRP203
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not established
CAS Number: 509088-69-1
Current Sponsor code: KRP203
Other descriptive name: KRP203-AAA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To assess the preliminary clinical efficacy of oral KRP203 in clinically active, treatment refractory patients with subacute cutaneous lupus erythematosus (SCLE) after 12 weeks of treatment with KPR203 as compared to placebo. Efficacy will be assessed by using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)

Secondary Objective: • To assess the safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus • To assess steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients • To assess changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient • To assess the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

Primary end point(s): Mean difference from baseline in the activity score of CLASI (from now on referred to only as CLASI)

Secondary ID(s)

CKRP203A2202