Drugs / Sprifermin
Sprifermin
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 missed | ||||||
| Phase 1 | NCT01033994 | Oct 2008 → Oct 2010 | osteoarthritis, knee | Merck KGaA, Darmstadt, Germany | Completed | Missed primary |
| Phase 1 | NCT00911469 | Nov 2007 → Apr 2010 | osteoarthritis, knee | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT01919164 | Jul 2013 → May 2016 | osteoarthritis, knee | EMD Serono Research & Development Institute, Inc. | Completed | Met primary |
| Phase 2 | NCT01689337 | Apr → Oct 2013 | — | EMD Serono | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01066871 | Mar 2010 → Apr 2013 | — | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-04-18 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, Presents New Osteoarthritis Data at OARSI 2018 World Congress prnewswire.com ↗
Results were consistent with the two-year results, which showed a statistically significant dose-dependent increase in cartilage thickness in total, lateral and medial femorotibial compartments as compared to placebo treatment, based on quantitative magnetic resonance imaging (qMRI). |
| 2017-11-04 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Presents Late Breaking Clinical Data from Phase II Trial of Sprifermin for Osteoarthritis Disease Modification prnewswire.com ↗
Demonstration of an increase in cartilage thickness as opposed to a delay in decreasing cartilage thickness has not been previously reported. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-04-18 | Merck KGaA, Darmstadt, Germany | Merck KGaA, Darmstadt, Germany, Presents New Osteoarthritis Data at OARSI 2018 World Congress prnewswire.com ↗ |
| 2017-11-04 | Merck KGaA, Darmstadt, Germany | Merck KGaA, Darmstadt, Germany Presents Late Breaking Clinical Data from Phase II Trial of Sprifermin for Osteoarthritis Disease Modification prnewswire.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sprifermin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01689337 ↗ |
| Known as | AS902330 | “Sprifermin (AS902330) will be administered at a dose of 30 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.” NCT01689337 ↗4“Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Knee Primary Osteoarthritis Who Are Candidates for Total Knee Replacement” NCT00911469 ↗ “Sprifermin (AS902330) will be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.” NCT01066871 ↗ “Sprifermin (AS902330) 30 mcg- 4 Cycles” NCT01919164 ↗ |
| Known as | Esprifermina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108302 ↗ |
| Known as | rhFGF-18 | “Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Knee Primary Osteoarthritis Who Are Candidates for Total Knee Replacement” NCT00911469 ↗ |
| Known as | Sprifermine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108302 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant human fibroblast growth factor 18” NCT01033994 ↗ |
| Route | Other | “intra-articular injection” NCT01033994 ↗ |