Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01294774
First received: February 10, 2011
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Subacute Cutaneous Lupus Erythematosus
Drug: KRP203 - 1.2mg
Drug: Placebo to KRP203 - 1.2 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KRP203 - 1.2 mg Drug: KRP203 - 1.2mg
Placebo Comparator: Placebo to KRP203 - 1.2 mg Drug: Placebo to KRP203 - 1.2 mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294774

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, Greece, GR 161 21
Novartis Investigative Site
Thessaloniki, Greece, GR 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01294774     History of Changes
Other Study ID Numbers: CKRP203A2202, 2010-019689-10
Study First Received: February 10, 2011
Last Updated: April 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Lupus erythematosus
skin lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014