Drugs / CHS-0214
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02486939 | Jul 2015 → Sep 2017 | psoriasis, rheumatoid arthritis | Coherus Oncology, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02134210 | Jun 2014 → Jul 2015 | psoriasis | Coherus Oncology, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02115750 | May 2014 → Oct 2015 | rheumatoid arthritis | Coherus Oncology, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2016-10-06 | Coherus Oncology, Inc. | Results Coherus BioSciences Completes two Pharmacokinetic Bioequivalence Studies of CHS-0214 coherus.com ↗
The ‘06 Study achieved the primary PK BE endpoint, as the 90% confidence intervals for the geometric mean ratio for the two groups was within 80% to 125% for all PK parameters. |
| 2016-06-10 | Coherus Oncology, Inc. | Results Coherus Presents Study Results Demonstrating Equivalence of its CHS-0214 Biosimilar to Etanercept coherus.com ↗
Results of the study demonstrated the equivalence of CHS-0214 to etanercept with respect to efficacy as measured by a primary endpoint. |
| 2016-01-12 | Daiichi Sankyo | Results Daiichi Sankyo Announces Results of Phase 3 International Joint Trial (RApsody) of Investigational Etanercept Biosimilar daiichisankyo.com ↗
The primary endpoint (ACR20*2), evaluating the disease activity of rheumatoid arthritis at 24 weeks after the administration of CHS-0214, met the criteria of equivalence as defined in advance in CHS-0214 and reference product groups, achieving the intended purpose. |
| 2016-01-11 | Coherus Oncology, Inc. | Results Coherus and Baxalta Announce CHS-0214 (Investigational Etanercept Biosimilar) Met Primary Efficacy Endpoint in Phase 3 Rheumatoid Arthritis Clinical Study (RaPsODY) coherus.com ↗
The primary endpoint was within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel. |
| 2015-11-09 | Coherus Oncology, Inc. | Results Coherus BioSciences Reports Third Quarter 2015 Financial and Operating Results and Corporate Events coherus.com ↗
Coherus and Baxalta announced today that CHS-0214 met its primary efficacy endpoints in its phase 3 psoriasis clinical study. |
| 2015-11-09 | Coherus Oncology, Inc. | Results Coherus and Baxalta Announce CHS-0214 (Investigational Etanercept Biosimilar) Met Primary Efficacy Endpoints in Phase 3 Psoriasis Clinical Study (RaPsODY) coherus.com ↗
Coherus BioSciences, Inc. (NASDAQ:CHRS) and Baxalta Incorporated (NYSE:BXLT) today announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study. |
All press releases naming this drug 11 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CHS-0214 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02115750 ↗ |
| Route | Subcutaneous | “50mg subcutaneous (Sc)” NCT02134210 ↗ |