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Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01294774
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE February 10, 2011
First Posted Date  ICMJE February 11, 2011
Last Update Posted Date March 22, 2017
Study Start Date  ICMJE February 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus [ Time Frame: 12 weeks ]
  • Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients [ Time Frame: 12 weeks ]
  • 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 ]
  • Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Subacute Cutaneous Lupus Erythematosus
Intervention  ICMJE
  • Drug: KRP203 - 1.2mg
  • Drug: Placebo to KRP203 - 1.2 mg
Study Arms  ICMJE
  • Experimental: KRP203 - 1.2 mg
    Intervention: Drug: KRP203 - 1.2mg
  • Placebo Comparator: Placebo to KRP203 - 1.2 mg
    Intervention: Drug: Placebo to KRP203 - 1.2 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2016)
10
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2011)
24
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Greece,   Italy
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01294774
Other Study ID Numbers  ICMJE CKRP203A2202
2010-019689-10 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP