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

Primary Purpose

Systemic Lupus Erythematosus

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Fostamatinib Disodium (R935788)

Placebo

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

150 mg tablet, oral, twice-a-day

Placebo tablet, oral, twice-a-day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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.

Decrease from baseline in SELENA-SLEDAI score at each post baseline visit.

Attainment of improvement in SELENA-SLEDAI by ≥ 2 points at Weeks 2 and 4.

Attainment of improvement in SELENA-SLEDAI by ≥ 4 points at each post baseline visit.

Change from baseline of Physician Global Assessment by VAS over 6 months.

Time to rescue medication.

Time to severe SLE flare by SELENA Flare Index.

Change from baseline in the component scores of the SF 36 at Month 3 and Month 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.

Full Information

NCT ID

NCT00752999

First Posted

September 15, 2008

Last Updated

April 26, 2012

Sponsor

Rigel Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00752999

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Study was withdrawn for business reasons before study start.

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2009 (Anticipated)

Study Completion Date

March 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rigel Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

SLE, Lupus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

150 mg tablet, oral, twice-a-day

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo tablet, oral, twice-a-day

Intervention Type

Drug

Intervention Name(s)

Fostamatinib Disodium (R935788)

Other Intervention Name(s)

R788

Intervention Description

150 mg tablet, oral, twice-a-day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet, oral, twice-a-day

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

3 and 6 months

Title

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

Title

Decrease from baseline in SELENA-SLEDAI score at each post baseline visit.

Time Frame

At each post baseline visit

Title

Attainment of improvement in SELENA-SLEDAI by ≥ 2 points at Weeks 2 and 4.

Time Frame

Weeks 2 and 4

Title

Attainment of improvement in SELENA-SLEDAI by ≥ 4 points at each post baseline visit.

Time Frame

At each post baseline visit

Title

Change from baseline of Physician Global Assessment by VAS over 6 months.

Time Frame

6 months

Title

Time to rescue medication.

Time Frame

At each post baseline visit

Title

Time to severe SLE flare by SELENA Flare Index.

Time Frame

At each post baseline visit

Title

Change from baseline in the component scores of the SF 36 at Month 3 and Month 6.

Time Frame

Month 3 and 6

Title

Time Frame

At each post baseline visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel B. Magilavy, MD

Organizational Affiliation

Rigel Pharmaceuticals, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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