Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus... | NCT01294774

Studies
Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

NCT01294774

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Mar 22, 2017Actual

Enrollment

10Actual

Phase

Phase 2

Conditions

Subacute Cutaneous Lupus Erythematosus

Interventions

KRP203 - 1.2mg
Placebo to KRP203 - 1.2 mg

Countries

Germany
Greece
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-019689-10	EudraCT Number

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Feb 10, 2011

First Submission Date that Met QC Criteria

Feb 10, 2011

First Posted Date

Feb 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2017

Last Update Posted Date

Mar 22, 2017Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
KRP203 - 1.2 mg	Experimental		Drug: KRP203 - 1.2mg
Placebo to KRP203 - 1.2 mg	Placebo Comparator		Drug: Placebo to KRP203 - 1.2 mg

Name	Type	Description	Arm Group Labels	Other Names
KRP203 - 1.2mg	Drug		KRP203 - 1.2 mg
Placebo to KRP203 - 1.2 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus		12 weeks
Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients		12 weeks

Other Outcomes

Not provided

Eligibility Module

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:

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.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Bochum		44791	Germany
Novartis Investigative Site

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases