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R788

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Rigel Pharmaceuticals, Inc.|Last Updated: Apr 20, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment189

FDA Designations

No designations recorded

Clinical trial landscape

R788 · 1 trial · 1 indication

Phase 2 1
NCT00326339Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)Rheumatoid Arthritis
COMPLETED189 Analytics
PHASE2COMPLETED
Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

The Primary Efficacy parameter is ACR20 response rate at 3 months post dosing.
12 weeks

Secondary Endpoints

ACR 20/50 responses over time
12 weeks
Disease Activity Score (DAS) at baseline and endpoint
12 Weeks
Mean changes (SDs) from baseline in Swollen Joint Count (28 joint count)
12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALR788 50 mg PO bid
2EXPERIMENTALR788 100 mg PO bid
3EXPERIMENTALR788 150 mg PO bid
4PLACEBO_COMPARATORPlacebo PO bid

Interventions

NameTypeDescription
R788DRUGR788 50 mg, 100 mg, or 150 mg PO bid
PlaceboDRUGPlacebo PO bid
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: 1. Patients must give written informed consent by signing an IRB-approved Informed Consent Form (ICF) prior to admission to this study. 2. Males and females, 18 to 75 years of age, with active RA for at least 12 months (functional class I-III, e.g., not bed or wheelchair-bound) ...

Countries:United StatesMexico
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Frequently asked questions about R788

What is R788 used for?

R788 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It is in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated in patients with this autoimmune condition to assess its safety and efficacy.

What does R788 target?

R788 targets Syk kinase, an enzyme involved in immune cell signaling. By inhibiting Syk kinase, R788 is designed to modulate the inflammatory response implicated in rheumatoid arthritis. This mechanism is the basis for its investigation as a potential treatment for the disease.

Who makes R788?

R788 is being developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RIGL. The company is conducting clinical trials to evaluate the drug's potential in treating rheumatoid arthritis.

What phase is R788 in?

R788 is in Phase 2 clinical development for rheumatoid arthritis. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 2 trial has been completed, and the drug remains under evaluation for its safety and effectiveness.

What clinical trials is R788 in?

R788 has been studied in a Phase 2 clinical trial with the identifier NCT00326339, titled 'Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)'. This completed trial enrolled 189 participants with rheumatoid arthritis and was conducted in the United States and Mexico.

Is R788 the same as fostamatinib?

Yes, R788 is also known as fostamatinib. It is an investigational small molecule Syk kinase inhibitor being developed by Rigel Pharmaceuticals for rheumatoid arthritis. The drug has completed a Phase 2 trial and remains in clinical development.