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)
Why this work is in the frame
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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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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it