Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00752999
• Date of registration: 15/09/2008
• Prospective Registration: Yes
• Primary sponsor: Rigel Pharmaceuticals
• Public title: Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus SOLEIL
• Scientific title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease
• Date of first enrolment: November 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00752999
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Contacts

• Name: Daniel B. Magilavy, MD
• Affiliation: Rigel Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: Fostamatinib Disodium (R935788)

Primary Outcome(s)

The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months. [Time Frame: 6 months]

Secondary Outcome(s)

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 = 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]

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 improvement in SELENA-SLEDAI by = 2 points at Weeks 2 and 4. [Time Frame: Weeks 2 and 4]

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]

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]

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]

Secondary ID(s)

C-935788-015

2008-004472-50

Source(s) of Monetary Support

Please refer to primary and secondary sponsors