Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

Subacute Cutaneous Lupus Erythematosus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294774
• Other study ID #: CKRP203A2202
• Secondary ID: 2010-019689-10
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2011
• Last updated: March 20, 2017
• Start date: February 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic
• Subacute Cutaneous Lupus Erythematosus

Intervention

Drug:
• KRP203 - 1.2mg

• Placebo to KRP203 - 1.2 mg

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Frankfurt am Main
Germany	Novartis Investigative Site	Tuebingen
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Thessaloniki	GR
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Siena	SI

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of KRP203 in reduction of severity of symptoms, as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)		12 weeks
Secondary	Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus		12 weeks
Secondary	Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients		12 weeks
Secondary	Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient		12 weeks
Secondary	Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)		12 weeks

External Links

•   Results for CKRP203A2202 from Novartis Clinical Trial Results website