Systemic Lupus ErythematosusPhase 2SOLEILNCT00752999
Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus
A Phase 2 study testing Fostamatinib Disodium (R935788) in people with Systemic Lupus Erythematosus, run by Rigel Pharmaceuticals.
Trial summary
Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Fostamatinib Disodium (R935788)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must give written informed consent to participate in this study by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
- Males and females, 18 years of age or older, with active SLE diagnosed at least 6 months prior to Day 1 dosing. Active SLE is defined as having fulfilled the ACR criteria for SLE.
- Patients of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use an effective method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent).
- The patient must otherwise be in good health as determined by the investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period.
- In the investigator's opinion, the patient has the ability to understand the nature of the study and any anticipated risks of participation, communicate satisfactorily with the investigator, and participate in and comply with the requirements of the entire protocol.
Who cannot join
- The patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study.
- Clinically significant or uncontrolled medical disease in any organ system, other than due to SLE.
- Background immunosuppressive therapy that has not remained stable ≤ 4 weeks prior to baseline.
- Severe active or unstable renal disease.
- Active severe neuropsychiatric SLE.
- Female patients must not be breastfeeding and must have a negative urine pregnancy test per the Schedule of Study Activities.
- The patient has a history of substance abuse, drug addiction, or alcoholism.
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease
Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. The investigator should taper corticosteroids if clinically warranted.
Read the detailed description
This study is a multi-center, multinational, randomized, double-blind, placebo-controlled Phase II clinical trial. Study enrollment will comprise approximately 225 patients meeting study inclusion requirements. The study will be conducted at up to 80 multinational investigational sites. Eligible patients will be randomized (2:1) into one of two 6 month treatment groups. One group (approximately 150 patients) will receive R788 150 mg PO bid; the other treatment group (approximately 75 patients) will receive placebo.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Fostamatinib Disodium (R935788), Placebo
- Keywords
- SLE, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostamatinib Disodium (R935788)Drug
Also called R788
150 mg tablet, oral, twice-a-day
PlaceboDrug
Placebo tablet, oral, twice-a-day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 150 mg tablet, oral, twice-a-day Receives: Drug: Fostamatinib Disodium (R935788) |
| B | Placebo comparator | Placebo tablet, oral, twice-a-day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months.
Measured: 6 months
Secondary outcomes (10)
Composite Responder analysis defined as ≥4 points improvement in SELENA-SLEDAI and no 'Severe SLE flare' after Week 6. No worsening (≤10 mm on VAS) of Physician Global Assessment, or, no worsening of SF 36 PCS (not >-0.8) or PFI (not >2.5)
Measured: 3 and 6 months
Attainment of daily prednisone dose decrease in those patients on daily corticosteroids by 50% or to ≤ 7.5 mg prednisone (or equivalent for other corticosteroids) at 3 and 6 months.
Measured: 3 and 6 months
Decrease from baseline in SELENA-SLEDAI score at each post baseline visit.
Measured: At each post baseline visit
Attainment of improvement in SELENA-SLEDAI by ≥ 2 points at Weeks 2 and 4.
Measured: Weeks 2 and 4
Attainment of improvement in SELENA-SLEDAI by ≥ 4 points at each post baseline visit.
Measured: At each post baseline visit
Change from baseline of Physician Global Assessment by VAS over 6 months.
Measured: 6 months
Time to rescue medication.
Measured: At each post baseline visit
Time to severe SLE flare by SELENA Flare Index.
Measured: At each post baseline visit
Change from baseline in the component scores of the SF 36 at Month 3 and Month 6.
Measured: Month 3 and 6
Effects on liver function tests, clinically significant reductions in peripheral neutrophil counts, G-I adverse effects, new onset or aggravated hypertension, and other adverse effects as they may appear.
Measured: At each post baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009 (estimated)
- Study completionMar 2010 (estimated)
Why it stopped: Study was withdrawn for business reasons before study start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel B. Magilavy, MD, Study director, Rigel Pharmaceuticals,Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752999
- Sponsor's protocol ID
- C-935788-015
- Other IDs
- 2008-004472-50, 2008
- Acronym
- SOLEIL
- Status last verified
- Apr 2012
- First submitted
- 15 Sep 2008
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease
- ClinicalTrials.gov ID
- NCT00752999
- Acronym / sponsor ID
- SOLEIL / C-935788-015
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Lupus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn for business reasons before study start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 16 Sep 2008 (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.
Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. The investigator should taper corticosteroids if clinically warranted.
Detailed description
This study is a multi-center, multinational, randomized, double-blind, placebo-controlled Phase II clinical trial. Study enrollment will comprise approximately 225 patients meeting study inclusion requirements. The study will be conducted at up to 80 multinational investigational sites. Eligible patients will be randomized (2:1) into one of two 6 month treatment groups. One group (approximately 150 patients) will receive R788 150 mg PO bid; the other treatment group (approximately 75 patients) will receive placebo.
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 |
|---|---|---|
| A | Experimental | Drug: Fostamatinib Disodium (R935788)150 mg tablet, oral, twice-a-day |
| B | Placebo comparator | Drug: PlaceboPlacebo tablet, oral, twice-a-day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must give written informed consent to participate in this study by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
- Males and females, 18 years of age or older, with active SLE diagnosed at least 6 months prior to Day 1 dosing. Active SLE is defined as having fulfilled the ACR criteria for SLE.
- Patients of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use an effective method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent).
- The patient must otherwise be in good health as determined by the investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period.
- In the investigator's opinion, the patient has the ability to understand the nature of the study and any anticipated risks of participation, communicate satisfactorily with the investigator, and participate in and comply with the requirements of the entire protocol.
Key exclusion criteria (7 listed)
- The patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study.
- Clinically significant or uncontrolled medical disease in any organ system, other than due to SLE.
- Background immunosuppressive therapy that has not remained stable ≤ 4 weeks prior to baseline.
- Severe active or unstable renal disease.
- Active severe neuropsychiatric SLE.
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 |
|---|---|---|
| Fostamatinib Disodium (R935788)Also: R788150 mg tablet, oral, twice-a-day | Drug | A |
| PlaceboPlacebo tablet, oral, twice-a-day | Drug | B |
Primary outcome
The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months.
Time frame: 6 months
10 secondary outcomes
Composite Responder analysis defined as ≥4 points improvement in SELENA-SLEDAI and no 'Severe SLE flare' after Week 6. No worsening (≤10 mm on VAS) of Physician Global Assessment, or, no worsening of SF 36 PCS (not >-0.8) or PFI (not >2.5)
Time frame: 3 and 6 months
Attainment of daily prednisone dose decrease in those patients on daily corticosteroids by 50% or to ≤ 7.5 mg prednisone (or equivalent for other corticosteroids) at 3 and 6 months.
Time frame: 3 and 6 months
Decrease from baseline in SELENA-SLEDAI score at each post baseline visit.
Time frame: At each post baseline visit
Attainment of improvement in SELENA-SLEDAI by ≥ 2 points at Weeks 2 and 4.
Time frame: Weeks 2 and 4
Attainment of improvement in SELENA-SLEDAI by ≥ 4 points at each post baseline visit.
Time frame: At each post baseline visit
Change from baseline of Physician Global Assessment by VAS over 6 months.
Time frame: 6 months
Time to rescue medication.
Time frame: At each post baseline visit
Time to severe SLE flare by SELENA Flare Index.
Time frame: At each post baseline visit
Change from baseline in the component scores of the SF 36 at Month 3 and Month 6.
Time frame: Month 3 and 6
Effects on liver function tests, clinically significant reductions in peripheral neutrophil counts, G-I adverse effects, new onset or aggravated hypertension, and other adverse effects as they may appear.
Time frame: At each post baseline visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
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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.
Daniel B. Magilavy, MD study director
Rigel Pharmaceuticals,Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fostamatinib Disodium (R935788) in people with Systemic Lupus Erythematosus, run by Rigel Pharmaceuticals.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months. (time frame: 6 months). 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 30 Apr 2012.