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.
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
- Are there results?
- None posted in the registry
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.
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
Greece2 sites
Novartis Investigative Site
Athens, GR, 161 21
Novartis Investigative Site
Thessaloniki, GR, 546 29
Italy2 sites
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Siena, SI, 53100
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01294774
- Acronym / sponsor ID
- CKRP203A2202
- Conditions
- Subacute Cutaneous Lupus Erythematosus
- Keywords
- Lupus erythematosus, skin lupus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KRP203 - 1.2 mg | Experimental | Drug: KRP203 - 1.2mg |
| Placebo to KRP203 - 1.2 mg | Placebo comparator | Drug: Placebo to KRP203 - 1.2 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (11 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KRP203 - 1.2mg | Drug | KRP203 - 1.2 mg |
| Placebo to KRP203 - 1.2 mg | Drug | Placebo to KRP203 - 1.2 mg |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Related trials for Subacute Cutaneous Lupus Erythematosus
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A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
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Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
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Active, not recruitingPhase 2/3
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
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The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Greece, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.