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ATN-103 q4wks

Phase 1

Rheumatoid Arthritis | Monoclonal antibody | Immunology |Sanofi|Last Updated: Sep 4, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

ATN-103 q4wks · 1 trial · 1 indication

Phase 1 1
NCT01007175Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED60 Analytics
PHASE1COMPLETED
Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability will be evaluated on the basis of AEs, SAEs,(including injection site reactions and infections), physical examination findings, vital sign, measurements, immunogenicity assessments, early termination, and clinical laboratory test.
20 weeks

Secondary Endpoints

Clinical efficacy for Rheumatoid Arthritis (RA) based on ACR responses, ACR-N, DAS 28 and EULAR response.
16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 5EXPERIMENTAL -

Interventions

NameTypeDescription
ATN-103 10 mg q4wksBIOLOGICALATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
ATN-103 30 mg q4wksBIOLOGICALATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.3 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
ATN-103 80 mg q4wksBIOLOGICALATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
ATN-103 10 mg q8wksBIOLOGICALATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections.
ATN-103 80 mg q8wksBIOLOGICALATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections.
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Meets the ACR 1987 revised criteria for classification of Rheumatoid Arthritis (RA). * ACR functional class I through III. * Active RA at the time of screening and at baseline consisting of = 6 swollen and = 6 tender joints at least. * hs-CRP level = 8 mg/L. * Must be receivin...

Countries:Japan
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Frequently asked questions about ATN-103 q4wks

What is ATN-103 q4wks used for in rheumatoid arthritis?

ATN-103 q4wks is an investigational monoclonal antibody being studied for the treatment of rheumatoid arthritis. It is administered every four weeks. The drug is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ATN-103 q4wks?

ATN-103 q4wks is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical development for rheumatoid arthritis.

What phase is ATN-103 q4wks in?

ATN-103 q4wks is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of rheumatoid arthritis.

What clinical trials is ATN-103 q4wks in?

ATN-103 q4wks has one completed clinical trial, NCT01007175, which studied multiple ascending doses of the drug in Japanese subjects with rheumatoid arthritis. The trial enrolled 60 participants and was a randomized, double-blind, controlled study.

Is ATN-103 q4wks the same as ATN-103?

ATN-103 q4wks refers to the dosing regimen of ATN-103 administered every four weeks. The drug is a monoclonal antibody being developed by Sanofi for rheumatoid arthritis. It is currently in Phase 1 clinical development.