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KRP203

Phase 2

Subacute Cutaneous Lupus Erythematosus | Small molecule | Immunology |Novartis AG|Last Updated: Mar 22, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

KRP203 · 1 trial · 1 indication

Phase 2 1
NCT01294774Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus ErythematosusSubacute Cutaneous Lupus Erythematosus
COMPLETED10 Analytics
PHASE2COMPLETED
Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus
Subacute Cutaneous Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KRP203 - 1.2 mgEXPERIMENTAL -
Placebo to KRP203 - 1.2 mgPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
KRP203 - 1.2mgDRUG -
Placebo to KRP203 - 1.2 mgDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites8

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) Exclus...

Countries:GermanyGreeceItaly
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Frequently asked questions about KRP203

What is KRP203 used for?

KRP203 is an investigational small molecule being studied for the treatment of subacute cutaneous lupus erythematosus, a form of lupus that affects the skin. It is being developed by Novartis AG and has completed a Phase 2 clinical trial.

What does KRP203 target?

KRP203 is a small molecule immunomodulator. Its specific molecular target has not been disclosed in available information. It is being investigated for its potential effects in subacute cutaneous lupus erythematosus, an autoimmune skin condition.

Who makes KRP203?

KRP203 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in clinical development for subacute cutaneous lupus erythematosus.

What phase is KRP203 in?

KRP203 is in Phase 2 clinical development. A Phase 2 trial for subacute cutaneous lupus erythematosus has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is KRP203 in?

KRP203 has one completed Phase 2 clinical trial, registered as NCT01294774, titled 'Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus'. The trial enrolled 10 participants and was conducted in Germany, Greece, and Italy.