NCT01294774

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2011

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

February 10, 2011

Last Update Submit

March 20, 2017

Conditions

Subacute Cutaneous Lupus Erythematosus

Keywords

Lupus erythematosusskin lupus

Outcome Measures

Primary Outcomes (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)

    12 weeks

Secondary Outcomes (4)

  • 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

  • Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

    12 weeks

Study Arms (2)

KRP203 - 1.2 mg

EXPERIMENTAL
Drug: KRP203 - 1.2mg

Placebo to KRP203 - 1.2 mg

PLACEBO COMPARATOR
Drug: Placebo to KRP203 - 1.2 mg

Interventions

KRP203 - 1.2mgDRUG
KRP203 - 1.2 mg
Placebo to KRP203 - 1.2 mgDRUG
Placebo to KRP203 - 1.2 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Frankfurt am Main, 60596, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Athens, GR, 161 21, Greece

Location

Novartis Investigative Site

Thessaloniki, GR, 546 29, Greece

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Interventions

KRP-203

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

GR(2)IT(2)DE(4)