Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

• ClinicalTrials.gov Identifier: NCT01294774
• Recruitment Status: Completed
• First Posted: February 11, 2011
• Last Update Posted: March 22, 2017
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Subacute Cutaneous Lupus Erythematosus	Drug: KRP203 - 1.2mg; Drug: Placebo to KRP203 - 1.2 mg	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: February 2011
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: KRP203 - 1.2 mg	Drug: KRP203 - 1.2mg
Placebo Comparator: Placebo to KRP203 - 1.2 mg	Drug: Placebo to KRP203 - 1.2 mg

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus [ Time Frame: 12 weeks ]
2. Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients [ Time Frame: 12 weeks ]
3. Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient [ Time Frame: 12 weeks ]
4. Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: 12 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Novartis Investigative Site

Bochum, Germany, 44791

Novartis Investigative Site

Bonn, Germany, 53105

Novartis Investigative Site

Frankfurt am Main, Germany, 60596

Novartis Investigative Site

Tuebingen, Germany, 72076

Greece

Novartis Investigative Site

Athens, GR, Greece, 161 21

Novartis Investigative Site

Thessaloniki, GR, Greece, 546 29

Italy

Novartis Investigative Site

Genova, GE, Italy, 16132

Novartis Investigative Site

Siena, SI, Italy, 53100

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01294774
• Other Study ID Numbers: CKRP203A2202; 2010-019689-10 ( EudraCT Number )
• First Posted: February 11, 2011
• Last Update Posted: March 22, 2017
• Last Verified: March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Lupus erythematosus; skin lupus

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases