Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATN-103 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1: ATN-103_30mg | EXPERIMENTAL | - |
| Arm 2: ATN-103_80 mg | EXPERIMENTAL | - |
| Treatment Group 1 | EXPERIMENTAL | ATN-103 10 mg every 4 weeks until week 12 |
| Treatment Group 2 | EXPERIMENTAL | ATN-103 10 mg every 8 weeks until week 12 |
| Treatment Group 3 | EXPERIMENTAL | ATN-103 30 mg every 4 weeks until week 12 |
| Treatment Group 4 | EXPERIMENTAL | ATN-103 80 mg every 4 weeks until week 12 |
| Treatment Group 5 | EXPERIMENTAL | ATN-103 80 mg every 8 weeks until week 12 |
| Treatment Group 6 | PLACEBO_COMPARATOR | Placebo every 4 weeks |
| Name | Type | Description |
|---|---|---|
| ATN-103 | DRUG | A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study) |
| Placebo | DRUG | Placebo every 4 weeks |
| Methotrexate | DRUG | - |
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...
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ATN-103 is being studied for the treatment of rheumatoid arthritis, including active rheumatoid arthritis. It is an investigational small molecule developed by Sanofi for the immunology therapeutic area. It has been evaluated in clinical trials in adults with rheumatoid arthritis, but it is not described as an approved therapy.
ATN-103 is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical studies of ATN-103 in rheumatoid arthritis, including a Phase 1 multiple-dose study and a Phase 2 long-term safety study.
ATN-103 is in Phase 1 development. A Phase 1 study of multiple doses in active rheumatoid arthritis has been completed, and a Phase 2 long-term safety study in rheumatoid arthritis has also been completed. The program is not described as approved.
ATN-103 has been studied in two completed trials. NCT00959036 was a Phase 1 multiple-dose study in active rheumatoid arthritis with 252 participants. NCT01063803 was a Phase 2 long-term safety study in rheumatoid arthritis with 266 participants. Both were randomized, double-blind, and placebo-controlled.
The ATN-103 clinical program enrolled 266 participants in its long-term safety study, NCT01063803, and 252 participants in the Phase 1 multiple-dose study, NCT00959036. Both trials enrolled adults aged 18 years and older with rheumatoid arthritis and were conducted across multiple countries.