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

NCT00752999 | Withdrawn Phase 2 DMC

• 2 other identifiers: C-935788-0152008-004472-50
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; Lupus

Outcome Measures

Primary Outcomes (1)

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

  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)

  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.

  3 and 6 months

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

  At each post baseline visit

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

  Weeks 2 and 4

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

  At each post baseline visit

Study Arms (2)

A

EXPERIMENTAL

150 mg tablet, oral, twice-a-day

Drug: Fostamatinib Disodium (R935788)

B

PLACEBO COMPARATOR

Placebo tablet, oral, twice-a-day

Drug: Placebo

Interventions

Fostamatinib Disodium (R935788) DRUG

150 mg tablet, oral, twice-a-day

Also known as: R788

A

Placebo DRUG

Placebo tablet, oral, twice-a-day

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigel Pharmaceuticals: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Daniel B. Magilavy, MD

  Rigel Pharmaceuticals,Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: March 1, 2010
• Last Updated: April 30, 2012

Record last verified: 2012-04