- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00752999
Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus (SOLEIL)
April 26, 2012 updated by: Rigel Pharmaceuticals
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
150 mg tablet, oral, twice-a-day
|
150 mg tablet, oral, twice-a-day
Other Names:
|
Placebo Comparator: B
Placebo tablet, oral, twice-a-day
|
Placebo tablet, oral, twice-a-day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
3 and 6 months
|
Decrease from baseline in SELENA-SLEDAI score at each post baseline visit.
Time Frame: At each post baseline visit
|
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
|
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
|
At each post baseline visit
|
Change from baseline of Physician Global Assessment by VAS over 6 months.
Time Frame: 6 months
|
6 months
|
Time to rescue medication.
Time Frame: At each post baseline visit
|
At each post baseline visit
|
Time to severe SLE flare by SELENA Flare Index.
Time Frame: At each post baseline visit
|
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
|
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
|
At each post baseline visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Daniel B. Magilavy, MD, Rigel Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Anticipated)
November 1, 2009
Study Completion (Anticipated)
March 1, 2010
Study Registration Dates
First Submitted
September 15, 2008
First Submitted That Met QC Criteria
September 15, 2008
First Posted (Estimate)
September 16, 2008
Study Record Updates
Last Update Posted (Estimate)
April 30, 2012
Last Update Submitted That Met QC Criteria
April 26, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-935788-015
- 2008-004472-50 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Systemic Lupus Erythematosus
-
SanofiCompletedCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusJapan
-
Kyowa Kirin Co., Ltd.RecruitingHealthy Volunteers | Systemic Lupus Erythematosus (SLE) | Cutaneous Lupus Erythematosus (CLE)Japan
-
Second Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China; Hunan Provincial Natural Science... and other collaboratorsActive, not recruitingCutaneous Lupus Erythematosus | Systemic Lupus Erythematosus RashChina
-
University Hospital, BrestRecruitingSystemic Lupus Erythematosus (SLE)France
-
Beijing InnoCare Pharma Tech Co., Ltd.RecruitingSystemic Lupus Erythematosus, SLEChina
-
TJ Biopharma Co., Ltd.TerminatedSystemic Lupus Erythematosus (SLE)China
-
AstraZenecaActive, not recruitingActive Systemic Lupus ErythematosusThailand, Korea, Republic of, Philippines, China, Taiwan, Hong Kong
-
Novartis PharmaceuticalsActive, not recruitingSystemic Lupus Erythematosus (SLE)Hungary, Spain, Germany, Israel, Thailand, France, Russian Federation, China, Japan, Taiwan, Korea, Republic of, Poland, Australia, Argentina, Czechia
-
AstraZenecaPRA Health SciencesCompletedActive Systemic Lupus ErythematosusUnited States, France, Germany, Spain, Belgium, Russian Federation, Japan, Korea, Republic of, Argentina, Bulgaria, South Africa, Mexico, Canada, Brazil, Lithuania
-
Novartis PharmaceuticalsNot yet recruitingSystemic Lupus Erythematosus, SLE
Clinical Trials on Fostamatinib Disodium (R935788)
-
AstraZenecaTerminatedRheumatoid ArthritisUnited States, Bulgaria, Mexico, Peru, Poland, Romania, Belgium, Germany, France, Italy, Colombia
-
Rigel PharmaceuticalsCompletedImmune Thrombocytopenic PurpuraSpain, United States, Australia, Poland, United Kingdom, Canada, Czechia, Bulgaria, Romania, Austria, Denmark, Hungary, Italy, Netherlands, Norway
-
Rigel PharmaceuticalsCompletedImmune Thrombocytopenic PurpuraUnited States, Australia, United Kingdom, Canada, Italy, Denmark, Hungary, Netherlands
-
Rigel PharmaceuticalsCompletedRheumatoid ArthritisBelgium, United States, Colombia, France, Germany, Italy, Peru
-
Rigel PharmaceuticalsCompletedPurpura, Thrombocytopenic, IdiopathicUnited States
-
Rigel PharmaceuticalsCompletedImmune Thrombocytopenic PurpuraSpain, Norway, Poland, Czechia, Germany, United States, Austria, Bulgaria, Romania
-
Rigel PharmaceuticalsNo longer availableImmune Thrombocytopenic Purpura
-
Rigel PharmaceuticalsCompletedWarm Antibody Autoimmune Hemolytic AnemiaUnited States, Spain, Canada, Australia, Norway, France, Belarus, Germany, Netherlands, Belgium, United Kingdom, Austria, Czechia, Georgia, Italy, Russian Federation, Serbia, Ukraine, Romania, Denmark, Hungary, Bulgaria
-
Rigel PharmaceuticalsCompletedT Cell LymphomaUnited States, Canada
-
Rigel PharmaceuticalsEnrolling by invitationWarm Antibody Autoimmune Hemolytic AnemiaSpain, United States, Australia, Norway, Belarus, Germany, Netherlands, Belgium, Austria, Bulgaria, Czechia, France, Georgia, Italy, Russian Federation, Serbia, Ukraine, United Kingdom