A Randomized, Double-Blind, Placebo-Controlled Trial of Ozanimod, an Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative Colitis: Results of the Maintenance Period of the TOUCHSTONE Study
Bibliographic record
Abstract
Introduction: Ozanimod (RPC1063) is an oral, selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in clinical development for the treatment of ulcerative colitis (UC) and relapsing multiple sclerosis. The objective of the maintenance period of TOUCHSTONE was to evaluate the longer term efficacy and safety of 0.5 mg (low dose, LD) and 1 mg (high dose, HD) ozanimod in comparison to placebo (PBO), in patients with moderate to severe UC. Methods: This randomized, double-blind, placebo-controlled trial assessed the efficacy, safety and tolerability of two orally administered doses of ozanimod vs placebo in patients with moderate to severe UC. A total of 197 patients were randomized (1:1:1) and treated once daily with HD (n=67), LD (n=65) or PBO (n=65). As previously reported, a significantly greater proportion of patients receiving HD were in clinical remission, clinical response, and had mucosal improvement than placebo patients at week 8. Patients who achieved clinical response at week 8 continued into the maintenance period (MP) with their original treatment for an additional 24 weeks. Results: Of 197 patients in the induction period, 103 (52.3%) entered the MP and 91 (88.3%) completed. At Week 32 clinical remission occurred in 14/67 (20.9%), HD (p=0.0108 vs. PBO), 17/65 (26.2%), LD (p=0.0021), and 4/65 (6.2%), PBO; clinical response occurred in 34/67 (50.7%), HD (p=0.0002), 23/65 (35.4%), LD (p=0.0571), and 13/65 (20.0%), PBO; mucosal improvement (Mayo endo-subscore ≤1) occurred in 22/67 (32.8%) for HD (p=0.0046), 21/65 (32.3%), LD (p=0.0064), and 8/65 (12.3%), PBO. The improvement in total Mayo score at Week 32 from baseline was 3.4, HD (p=0.0004), 2.2, LD (p=0.1932), and 1.6, PBO. During the MP, adverse events (AEs) were most common in PBO. AEs occurred in 11/42 (26.2%), HD; 4/36 (11.1%), LD; 8/25 (32.0%), PBO. The most common AEs were: worsening of UC (HD, n=1; LD, 0; PBO, n=2) and UTI (HD, 0; LD, n=1; PBO, n=1). No AEs of special interest (cardiac, pulmonary, ophthalmologic, hepatic, malignancy or serious infections) were reported during the MP. Conclusion: Patients with moderate to severe UC who continued treatment with ozanimod were more likely to achieve and maintain clinical remission, clinical response and mucosal improvement than those receiving placebo. These data support the longer term efficacy and safety/tolerability profile of ozanimod in the treatment of moderate to severe UC.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 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) | 0.005 | 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".