drugset / Trial / NCT01226745
Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
Phase 2
Terminated
340 enrolled
EMD Serono
Merck KGaA, Darmstadt, Germany · collabOno Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 \[NCT01081782\]).
Timeline
- Start
- 2010-10
- Primary completion
- 2015-01
- Completion
- 2015-01
Outcome
Outcome not reported
Stopped: “Merck has decided to not pursue phase 3 development of ceralifimod (ONO-4641). The decision was not related to any safety and efficacy findings”
Publications
- Results Effect of Ceralifimod (ONO-4641), a Sphingosine-1-Phosphate Receptor-1 and -5 Agonist, on Magnetic Resonance Imaging Outcomes in Patients with Multiple Sclerosis: Interim Results from the Extension of the DreaMS Study (P3.161) Amit Bar-Or, Frauke Zipp, Matthew Scaramozza, Timothy Vollmer, Bryan Due, Karthinathan Thangavelu, Tanya Fischer, and Krzysztof Selmaj April 8, 2014 82:10 Supplement P3.161; 1526-632X
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ONO-4641 | Unknown | 0.05 mg | — |
| Subject | ONO-4641 | Unknown | 0.1 mg | — |
| Subject | ONO-4641 | Unknown | 0.15 mg | — |