Recent Updates
Recently added Catalysts

ATN-103

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Sanofi|Last Updated: Apr 11, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment266

FDA Designations

No designations recorded

Clinical trial landscape

ATN-103 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT01063803Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED266 Analytics
PHASE2COMPLETED
Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
NCT01063803266
Unlock trial analytics

Study Endpoints

Primary Endpoints

Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements.
18 months
American College of Rheumatology (ACR) 20 response at week 16
6 months
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
24weeks

Secondary Endpoints

Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments
6 months
Antibody in blood and drug concentration in blood and urine are evaluated.
24weeks
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: ATN-103_30mgEXPERIMENTAL -
Arm 2: ATN-103_80 mgEXPERIMENTAL -
Treatment Group 1EXPERIMENTALATN-103 10 mg every 4 weeks until week 12
Treatment Group 2EXPERIMENTALATN-103 10 mg every 8 weeks until week 12
Treatment Group 3EXPERIMENTALATN-103 30 mg every 4 weeks until week 12
Treatment Group 4EXPERIMENTALATN-103 80 mg every 4 weeks until week 12
Treatment Group 5EXPERIMENTALATN-103 80 mg every 8 weeks until week 12
Treatment Group 6PLACEBO_COMPARATORPlacebo every 4 weeks
1.5mgSCEXPERIMENTALATN-103
4mgSCEXPERIMENTALATN-103
10mgSCEXPERIMENTALATN-103
25mgSCEXPERIMENTALATN-103
25mgIVEXPERIMENTALATN-103
50mgSCEXPERIMENTALATN-103
100mgSCEXPERIMENTALATN-103
200mgSCEXPERIMENTALATN-103
200mgIVEXPERIMENTALATN-103

Interventions

NameTypeDescription
ATN-103DRUGA single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
PlaceboDRUGPlacebo every 4 weeks
MethotrexateDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study. Exclusion Criteria: * Pregnant or nursing women. * Any major illness/condition or evidenc...

Countries:United StatesCanadaHungaryJapanRussiaSerbiaSouth AfricaSwitzerlandBelgiumGermany
Unlock Eligibility Criteria

Competitive Landscape -Rheumatoid Arthritis 92 trials

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Adalimumab, Upadacitinib
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Adalimumab, Methotrexate
Eli Lilly and CompanyLLY4PHASE3Baricitinib, Tocilizumab
Johnson & JohnsonJNJ1PHASE3Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163
Novartis AG Sponsored ADRNVS3PHASE2VAY736 PFS, VAY736 AI
Merck & Co., Inc.MRK2PHASE2Tulisokibart, Methotrexate
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Sanofi SA Sponsored ADRSNY2PHASE2Sarilumab SAR153191
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix, Methotrexate
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2Allogeneic NK Cells
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Zenas BioPharma, Inc.ZBIO1PHASE1ZB002
Stryker CorporationSYK5N/AUndisclosed
Zimmer Biomet Holdings, Inc.ZBH29N/AUndisclosed
Cullinan Therapeutics, Inc.CGEM1PHASE1CLN-978
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
Unlock Competitive Intelligence

Frequently asked questions about ATN-103

What is ATN-103 used for?

ATN-103 is an investigational small molecule being developed by Sanofi for the treatment of rheumatoid arthritis. It has been studied in healthy volunteers and in patients with active rheumatoid arthritis. The drug is in clinical development and is not approved by the FDA.

Who makes ATN-103?

Sanofi (ticker: SNY) is developing ATN-103. The drug is a small molecule in the immunology therapeutic area, currently in Phase 1 clinical development for rheumatoid arthritis.

What phase is ATN-103 in?

ATN-103 is in Phase 1 clinical development. It has completed Phase 1 trials in healthy subjects and in patients with active rheumatoid arthritis. The drug is investigational and has not been approved.

What clinical trials has ATN-103 been in?

ATN-103 has been studied in three completed trials. NCT00916110 evaluated a single dose in healthy Japanese male subjects. NCT00959036 evaluated multiple doses in patients with active rheumatoid arthritis. NCT01063803 evaluated long-term safety in rheumatoid arthritis patients.

Is ATN-103 the same as any other drug?

ATN-103 is the drug name used in clinical trials. No alternative names have been reported for this investigational compound.