Efficacy Results of the Phase 2 Portion of the RADIANCE Trial: A Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 in Adults with Relapsing Multiple Sclerosis (P7.198)
Bibliographic record
Abstract
Objective: Demonstrate efficacy of low (LD, 0.5 mg) and high (HD, 1.0 mg) dose RPC1063 vs placebo (PBO) in relapsing multiple sclerosis (RMS). Background: RPC1063 is an oral sphingosine 1-phosphate (S1P) 1,5 receptor modulator in clinical development for RMS. Methods: RADIANCE is an ongoing international Phase 2/3 trial. In the 24-week, Phase 2 portion, 258 patients were randomized (1:1:1) to PBO (n=88), LD (n=87) or HD (n=83). The primary endpoint was cumulative number of total gadolinium-enhancing (GdE) MRI lesions from Wks 12-24. Key secondary endpoints included number of GdE lesions at Wk 24, cumulative number of new/enlarging T2 lesions from Wks 12-24, and annualized relapse rate (ARR). Results: 98[percnt] of patients completed the trial. Cumulative total Wk 12-24 GdE lesions decreased 86[percnt] in both RPC1063 arms vs PBO (mean±SD: PBO 11.1±29.9, LD 1.5±3.7, HD 1.5±3.4, p<0.0001). Numbers of GdE lesions at Wk 24 significantly decreased 91 and 94[percnt] vs PBO (PBO 3.2±9.8, LD 0.3±0.9, HD 0.2±0.6, both p<0.0001) and cumulative Wks 12-24 new/enlarging T2 lesions decreased 84 and 91[percnt] (PBO 9.0±20.9, LD 1.4±3.2, HD 0.8±1.9, both p<0.0001). Proportion of GdE lesion-free patients increased from baseline to Wk 24 with RPC1063 and decreased with PBO (PBO 70.5[percnt]-59.1[percnt], LD 60.9[percnt]-86.2[percnt], HD 62.7[percnt]-88.0[percnt], both doses p<0.0001 vs PBO at Wk 24). Time to first relapse increased with increasing dose with a significant increase in HD vs PBO (p=0.0397), while ARR reduction showed a favorable trend (LD: 31[percnt], p=0.27; HD: 53[percnt], p=0.053). Proportion of subjects with No Evidence of Disease Activity was significantly higher in both RPC1063 groups (LD 56.3[percnt], HD 55.4[percnt], PBO 26.1[percnt], both p<0.001). RPC1063 treatment was well tolerated with a good safety profile. Conclusions: Both doses of RPC1063 demonstrated significant efficacy on MRI measures, with the high dose also reducing clinical disease activity, supporting the ongoing Phase 3 portion (NCT02047734).
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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) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| 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".