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SBI-087

Phase 2

Active Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Aug 14, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment210

FDA Designations

No designations recorded

Clinical trial landscape

SBI-087 · 4 trials · 4 indications

Phase 2 1Phase 1 3
NCT01008852Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid ArthritisActive Rheumatoid Arthritis
COMPLETED210 Analytics
PHASE2COMPLETED
Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis
Active Rheumatoid Arthritis
NCT01008852210
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Study Endpoints

Primary Endpoints

Response as measured by American College of Rheumatology criteria (ACR 20 response)
16 weeks
Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE)
12 months
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
12 months
To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis.
12 months

Secondary Endpoints

ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response
up to 24 weeks
Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE)
12 months
To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA
12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group 1EXPERIMENTAL -
Treatment Group 2EXPERIMENTAL -
Treatment Group 3EXPERIMENTAL -
Treatment Group 4EXPERIMENTAL -
Treatment Group 5PLACEBO_COMPARATOR -
SBI-087EXPERIMENTAL -
SBI-087 0.15 mg IVEXPERIMENTAL -
SBI-087 0.5 mg IVEXPERIMENTAL -
SBI-087 100 mg SCEXPERIMENTAL -
SBI-087 200 mg SCEXPERIMENTAL -
1EXPERIMENTALSBI-087

Interventions

NameTypeDescription
SBI-087DRUG200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
PlaceboDRUGPlacebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites55

Inclusion Criteria: * Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening * Active RA as defined by \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following: C-r...

Countries:United StatesArgentinaCanadaChileHungaryJapanMexicoPolandSerbiaSpain
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Frequently asked questions about SBI-087

What is SBI-087 used for?

SBI-087 is an investigational small molecule being developed for rheumatoid arthritis and systemic lupus erythematosus. It has been studied in patients with active rheumatoid arthritis and in seropositive subjects with active disease. The drug is in Phase 2 clinical development for these autoimmune conditions.

Who is developing SBI-087?

SBI-087 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has conducted clinical trials of SBI-087 in the United States, Canada, Japan, and multiple other countries for rheumatoid arthritis and systemic lupus erythematosus.

What phase is SBI-087 in?

SBI-087 is in Phase 2 clinical development. A Phase 2 trial evaluating the efficacy and safety of SBI-087 in seropositive subjects with active rheumatoid arthritis has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has SBI-087 been in?

SBI-087 has been studied in four completed clinical trials. NCT01008852 was a Phase 2 study in 210 seropositive subjects with active rheumatoid arthritis. NCT00641225, NCT00714116, and NCT00815906 were Phase 1 studies in rheumatoid arthritis and systemic lupus erythematosus, with enrollments of 60, 30, and 20 participants respectively.

Is SBI-087 the same as other rheumatoid arthritis treatments?

SBI-087 is a distinct investigational small molecule developed by Pfizer. It has been evaluated in placebo-controlled, double-blind trials for rheumatoid arthritis and systemic lupus erythematosus. No alternative names for SBI-087 have been reported in clinical trial registrations.

What is the mechanism of action of SBI-087?

SBI-087 is a small molecule therapeutic being developed for autoimmune diseases. Its specific molecular target has not been disclosed in the clinical trial information available. The drug has been studied for its efficacy and safety in patients with active rheumatoid arthritis and systemic lupus erythematosus.