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Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

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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 )

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 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
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01294774     History of Changes
Other Study ID Numbers: CKRP203A2202
2010-019689-10 ( EudraCT Number )
First Posted: February 11, 2011    Key Record Dates
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