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REGN88

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Regeneron Pharmaceuticals, Inc.|Last Updated: Sep 30, 2013

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

REGN88 · 3 trials · 1 indication

Phase 1 3
NCT01011959A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis SubjectsRheumatoid Arthritis
COMPLETED60 Analytics
NCT01026519A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED32 Analytics
NCT01055899Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED15 Analytics
PHASE1COMPLETED
A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
Rheumatoid ArthritisUnlock trial analytics
PHASE1COMPLETED
A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics
PHASE1COMPLETED
Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
10 weeks
hs-C reactive protein (hs-CRP)
43 Days
To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate
113 Days

Secondary Endpoints

To evaluate exploratory efficacy endpoints
over 10 weeks
Subject's Assessment of Pain and Subject's Global Assessment of Disease activity
43 Days
To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88
113 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORdose 1 vs. placebo
2ACTIVE_COMPARATORdose 2 vs. placebo
3ACTIVE_COMPARATORdose 3 vs. placebo
4ACTIVE_COMPARATORdose 4 vs. placebo
5ACTIVE_COMPARATORdose 5 vs. placebo
6ACTIVE_COMPARATORdose 6 vs. placebo
Dose 1EXPERIMENTALActive dose
Dose 2EXPERIMENTALActive dose
Dose 3EXPERIMENTALActive 3
Dose 4PLACEBO_COMPARATORPlacebo dose

Interventions

NameTypeDescription
REGN88BIOLOGICALThis study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
PlaceboOTHERPlacebo to match REGN88 administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Patients with an established diagnosis of Rheumatoid Arthritis * Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks Exclusion Criteria: * Persistent chronic or current active infections * Patients who have ...

Countries:United StatesRussia
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Frequently asked questions about REGN88

What is REGN88 used for in Rheumatoid Arthritis?

REGN88 is an investigational small molecule being developed by Regeneron Pharmaceuticals for the treatment of Rheumatoid Arthritis. It is currently in Phase 1 clinical development, meaning it has not yet been approved by the FDA. The drug is being studied for its safety and tolerability in patients with this condition.

Who makes REGN88?

REGN88 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The drug is currently in Phase 1 clinical trials for Rheumatoid Arthritis, and it is an investigational small molecule therapy.

What phase is REGN88 in?

REGN88 is currently in Phase 1 clinical development. It has completed three Phase 1 trials, all of which were placebo-controlled and double-blinded, with a total enrollment of 107 participants. The drug is still investigational and has not been approved for any use.

What clinical trials is REGN88 in?

REGN88 has completed three Phase 1 clinical trials for Rheumatoid Arthritis: NCT01011959, a multiple-dose safety study in the United States with 60 participants; NCT01026519, a safety and tolerability study in Russia with 32 participants; and NCT01055899, a single-dose safety study in the United States with 15 participants.

Is REGN88 the same as SAR153191?

Yes, REGN88 is also known as SAR153191. This alternative name appears in the titles of its clinical trials, such as NCT01011959, which refers to REGN88(SAR153191). Both names refer to the same investigational drug being developed for Rheumatoid Arthritis.