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
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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 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |

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 |
- 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 ]
- 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 ]

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

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
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01294774 |
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 |
Lupus erythematosus skin lupus |
Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Skin Diseases |