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ATN-103 q4wks · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ATN-103 10 mg q4wks | BIOLOGICAL | ATN-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 q4wks | BIOLOGICAL | ATN-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 q4wks | BIOLOGICAL | ATN-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 q8wks | BIOLOGICAL | ATN-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 q8wks | BIOLOGICAL | ATN-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. |
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...
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ATN-103 q4wks is an investigational monoclonal antibody developed by Sanofi for rheumatoid arthritis. The q4wks designation refers to a once-every-four-weeks dosing schedule. It has been studied in a Phase 1 clinical trial in Japanese subjects with rheumatoid arthritis. It is not an approved therapy and remains in clinical development.
ATN-103 q4wks was studied as a treatment for rheumatoid arthritis, an inflammatory joint disease. The Phase 1 trial evaluated multiple ascending doses in Japanese subjects with rheumatoid arthritis. Because the program is at the Phase 1 stage, ATN-103 q4wks is investigational and has not been established as a treatment option for rheumatoid arthritis.
ATN-103 q4wks is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 1 study of the monoclonal antibody in Japanese subjects with rheumatoid arthritis. The asset sits within Sanofi's immunology pipeline.
ATN-103 q4wks is in Phase 1 clinical development. The single completed trial, NCT01007175, was a Phase 1 study of multiple ascending doses in Japanese subjects with rheumatoid arthritis. No later-stage trials are recorded for this asset, and it is not approved for any indication.
ATN-103 q4wks has been evaluated in one clinical trial, NCT01007175, titled Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis. The Phase 1 trial enrolled 60 participants in Japan, was randomized, double blind, and controlled, and its status is completed.