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

Systemic Lupus Erythematosus Clinical Trial

— SOLEIL  

Official title:

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00752999
• Other study ID #: C-935788-015
• Secondary ID: 2008-004472-50
• Status: Withdrawn
• Phase: Phase 2
• First received: September 15, 2008
• Last updated: April 26, 2012
• Start date: November 2008
• Est. completion date: March 2010

Study information

• Verified date: April 2012
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. The investigator should taper corticosteroids if clinically warranted.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Fostamatinib Disodium (R935788)
150 mg tablet, oral, twice-a-day
• Placebo
Placebo tablet, oral, twice-a-day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months.		6 months	No
Secondary	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)		3 and 6 months	No
Secondary	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.		3 and 6 months	No
Secondary	Decrease from baseline in SELENA-SLEDAI score at each post baseline visit.		At each post baseline visit	No
Secondary	Attainment of improvement in SELENA-SLEDAI by = 2 points at Weeks 2 and 4.		Weeks 2 and 4	No
Secondary	Attainment of improvement in SELENA-SLEDAI by = 4 points at each post baseline visit.		At each post baseline visit	No
Secondary	Change from baseline of Physician Global Assessment by VAS over 6 months.		6 months	No
Secondary	Time to rescue medication.		At each post baseline visit	No
Secondary	Time to severe SLE flare by SELENA Flare Index.		At each post baseline visit	No
Secondary	Change from baseline in the component scores of the SF 36 at Month 3 and Month 6.		Month 3 and 6	No
Secondary	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.		At each post baseline visit	Yes