Results from the 48-Week Blinded Extension of RADIANCE: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Oral Ozanimod in Relapsing Multiple Sclerosis (P3.023)
Bibliographic record
Abstract
OBJECTIVE: Demonstrate long-term efficacy and safety of low (LD, 0.5mg) and high (HD, 1mg) dose Ozanimod. BACKGROUND: Ozanimod (RPC1063) is an oral, selective S1P receptor modulator in development for treatment of relapsing multiple sclerosis. DESIGN/METHODS: RADIANCE is a Phase-2/3 trial. 24-week results demonstrated efficacy with LD and HD, compared to PBO, with a good safety profile. In the 48-week, blinded extension, patients originally randomized to Ozanimod continued their assigned dose (LDc,n=85; HDc,n=81) while PBO patients were re-randomized (LDp,n=41; HDp,n=42). RESULTS: 249 of 258 patients (97[percnt]) entered blinded extension. 230 (92[percnt]) completed Wk72 visit. In LDc and HDc, treatment effect on mean±SD GdE-lesions (0.4±1.4; 0.2±0.6) and proportion of patients GdE-lesion free (73[percnt]; 88[percnt]) at Wk72 were comparable to Wk24 and the unadjusted annualized relapse rate (uARR) dropped from 0.43 and 0.26 at Wk24 to 0.26 and 0.15 at Wk72. NEDA (no GdE/new/enlarging T2-lesions at Wk72, and no relapse or increase in EDSS from Wk24 to Wk72) was achieved in 44[percnt] (LDc) and 63[percnt] (HDc). In LDp and HDp, mean GdE-lesions reduced 91[percnt] (4.5±13.0 to 0.4±2.0) and 95[percnt] (1.9±5.9 to 0.1±0.3), proportion of patients GdE-lesion free was 85[percnt] and 79[percnt] at Wk72, uARR reduced from 0.5 at Wk24 to 0.26 and 0.16 at Wk72, while NEDA from Wk24 to Wk72 was achieved in 42[percnt] and 57[percnt]. AE profiles were comparable across dose groups. The most common AEs were minor infections and headache. Maximum mean first-dose heart rate reductions were <1bpm from baseline. Only 1 patient transiently had a minimum hourly heart rate <45bpm. No notable cardiac, pulmonary, ophthalmologic or malignancy AEs were observed. ALT ≥3x ULN occurred in 3.2[percnt] of patients. CONCLUSIONS: Both doses demonstrated efficacy over 48 and 72 weeks on MRI and MS disease activity in patients continuing Ozanimod or switching from PBO. Safety results suggest a favorable risk-benefit profile.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".