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SAN-300/kg QW

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Bausch Health Companies Inc.|Last Updated: Jun 21, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

SAN-300/kg QW · 1 trial · 1 indication

Phase 2 1
NCT02047604(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED41 Analytics
PHASE2COMPLETED
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events
10 weeks

Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.

Secondary Endpoints

Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)
Baseline, End of Treatment Visit (Week 7)
Number of Participants With American College of Rheumatology 20 (ACR20) Response.
End of Treatment Visit (Week 7)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A - SAN-300 0.5 mg/kg QWEXPERIMENTALSAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
Cohort B - SAN-300 1.0 mg/kg QWEXPERIMENTALSAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
Cohort C - SAN-300 2.0 mg/kg QOWEXPERIMENTALSAN-300 2.0 mg/kg subcutaneous every other week for six weeks
Cohort D - SAN-300 4.0 mg/kg QOWEXPERIMENTALSAN-300 4.0 mg/kg subcutaneous every other week for six weeks
Cohort E - SAN-300 4.0 mg/kg QWEXPERIMENTALSAN-300 4.0 mg/kg subcutaneous every other week for six weeks
PlaceboPLACEBO_COMPARATORPlacebo dosing

Interventions

NameTypeDescription
SAN-300 0.5 mg/kg QWDRUG -
SAN-300 1.0 mg/kg QWDRUG -
SAN-300 2.0 mg/kg QOWDRUG -
SAN-300 4.0 mg/kg QOWDRUG -
SAN-300 4.0 mg/kg QWDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010 2. 18 to 75 years of age, inclusive, at the time of informed consent 3. Swollen joint count of ≥ 6 (66-joint count) and...

Countries:United States
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Frequently asked questions about SAN-300/kg QW

What is SAN-300/kg QW used for?

SAN-300/kg QW is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with rheumatoid arthritis to evaluate its safety and efficacy.

Who makes SAN-300/kg QW?

SAN-300/kg QW is being developed by Bausch Health Companies Inc., a company listed on the stock exchange under the ticker symbol BHC. The drug is currently in Phase 2 clinical development for the treatment of rheumatoid arthritis.

What phase is SAN-300/kg QW in?

SAN-300/kg QW is in Phase 2 clinical development. It is an investigational drug being studied for the treatment of rheumatoid arthritis and has not yet been approved by regulatory authorities. The drug is still in clinical trials and its safety and efficacy have not been fully established.

What clinical trials is SAN-300/kg QW in?

SAN-300/kg QW has been studied in one completed Phase 2 clinical trial with the identifier NCT02047604. This trial, titled "(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis," enrolled 41 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is SAN-300/kg QW the same as SAN-300?

SAN-300/kg QW is a dosing regimen of the drug SAN-300, where the drug is administered once weekly. The clinical trial for SAN-300/kg QW, NCT02047604, evaluated escalating doses of SAN-300 in patients with rheumatoid arthritis. The drug is being developed by Bausch Health Companies Inc.