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 )

Tracking Information

• First Submitted Date: February 10, 2011
• First Posted Date: February 11, 2011
• Last Update Posted Date: March 22, 2017
• Study Start Date: February 2011
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Subacute Cutaneous Lupus Erythematosus

Intervention

• Drug: KRP203 - 1.2mg
• Drug: Placebo to KRP203 - 1.2 mg

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 15, 2016): 10
• Original Estimated Enrollment (submitted: February 10, 2011): 24
• Actual Study Completion Date: October 2012
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Greece, Italy
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT01294774
• Other Study ID Numbers: CKRP203A2202; 2010-019689-10 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Study Sponsor: Novartis Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: March 2017