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)
Bibliographic record
Abstract
OBJECTIVE: To evaluate the effect of ceralifimod (ONO-4641) on magnetic resonance imaging (MRI) outcomes during the first 6 months of a 225-week extension to the DreaMS (Drug Research and EvaluAtion in Multiple Sclerosis) study. BACKGROUND: The randomized, double-blind, 26-week, placebo-controlled Phase 2 DreaMS study showed that oral ceralifimod (ONO-4641) significantly reduced key MRI measures of disease in patients with relapsing-remitting multiple sclerosis. METHODS: Patients continued their core study-assigned dose of ceralifimod (ONO-4641) or were re-randomized from placebo to active treatment (0.05, 0.10 or 0.15 mg; dose-blinded). The interim analysis was performed 6 months into the extension (Week 52: representing 26 weeks of core study and 26 weeks of extension). MRI measures included the numbers of T1-weighted gadolinium-enhancing (Gd+) and new/enlarging T2-weighted lesions, and the proportions of patients free of new/enlarging T2 lesions or Gd+ lesions at extension study baseline and Week 52. RESULTS: Of 360 patients who completed the core study, 343 entered the extension and 310 (90.4%) completed at least 6 months of the extension. At extension study baseline, mean numbers of new/enlarging T2 lesions were 2.4 (placebo/0.05 mg), 3.2(placebo/0.10 mg), 2.5 (placebo/0.15 mg), 0.3 (0.05 mg), 0.1 (0.10 mg), and 0.2 (0.15 mg). By Week 52, these values were 1.0, 0.1, 0.6, 0.8, 0.5, and 0.4, respectively. The proportions of patients free of new/enlarging T2 lesions increased from extension study baseline to Week 52 in patients switched to active treatment: placebo/0.05 mg, 52% to 62%; placebo/0.10 mg, 56% to 87%; placebo/0.15 mg, 21% to 71%. Consistent effects were seen on the mean number of Gd+ lesions and patients free of Gd+ lesions. CONCLUSIONS: There were notable reductions in the numbers of new/enlarging T2 lesions in patients switching from placebo to active treatment in the extension study, while efficacy was sustained for patients on continuous active treatment. Study Support: Merck Serono SA, Geneva, Switzerland; EMD Serono, Inc., Rockland, MA, USA; Ono Pharmaceutical Co. Ltd, Osaka, Japan
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".