Subacute Cutaneous Lupus ErythematosusPhase 2NCT01294774

Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

A Phase 2 study testing KRP203 - 1.2mg in people with Subacute Cutaneous Lupus Erythematosus, run by Novartis Pharmaceuticals at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Subacute Cutaneous Lupus Erythematosus
What is being tested?: KRP203 - 1.2mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 8 sitesin 3 countries
Study dates: Feb 2011to Oct 2012
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

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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

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

Germany4 sites

Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Frankfurt am Main, 60596
Novartis Investigative Site
Tübingen, 72076

Other trials in Germany

Greece2 sites

Novartis Investigative Site
Athens, GR, 161 21
Novartis Investigative Site
Thessaloniki, GR, 546 29

Other trials in Greece

Italy2 sites

Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Siena, SI, 53100

Other trials in Italy

About this study

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

Conditions: Subacute Cutaneous Lupus Erythematosus
Being tested: KRP203 - 1.2mg, Placebo to KRP203 - 1.2 mg
Keywords: Lupus erythematosus, skin lupus
Medical subject headings: Lupus Erythematosus, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KRP203 - 1.2mgDrug
Placebo to KRP203 - 1.2 mgDrug

Study groups in NCT01294774
Study group	Role	What they receive
KRP203 - 1.2 mg	Experimental	Not described Receives: Drug: KRP203 - 1.2mg
Placebo to KRP203 - 1.2 mg	Placebo comparator	Not described Receives: Drug: Placebo to KRP203 - 1.2 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 12 weeks

Secondary outcomes (4)

Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus
Measured: 12 weeks
Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients
Measured: 12 weeks
Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient
Measured: 12 weeks
Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Oct 2012

First posted11 Feb 2011 (estimated)
Study startFeb 2011
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Subacute Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01294774
Sponsor's protocol ID: CKRP203A2202
Other IDs: 2010-019689-10
Status last verified: Mar 2017
First submitted: 10 Feb 2011
Last updated: 22 Mar 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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