Trial reportJournal of Crohn's & colitis2026
Safety and tolerability of anti-toll-like receptor 3, monoclonal antibody PRV-300 in patients with moderate-to-severe ulcerative colitis: a randomized phase 1B clinical trial (PULSE).
Trial report in Journal of Crohn's & colitis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03849599 (A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
BACKGROUND &
aimsPRV-300 is a fully human IgG4κ monoclonal antibody that binds the extracellular domain of human toll-like receptor 3, which is overexpressed in the inflamed colonic epithelium in patients with inflammatory bowel disease. This study aimed at proving its safety and efficacy in patients with ulcerative colitis (UC).
methodsPatients with moderate-to-severe UC (Mayo Clinical Score [MCS] 6-12) were randomized to receive 7 doses of PRV-300 intravenously or matched placebo (PBO). After a 12-week treatment period, participants underwent an 8-week follow-up. The primary endpoint was to assess the safety and tolerability of PRV-300. Secondary endpoints included assessment of pharmacodynamics, pharmacokinetics, immunogenicity, and endoscopic disease activity.
resultsIn total, 38 patients were randomized (28 in PRV-300 arm, 9 in placebo arm), of whom 32 completed the trial (24 and 8, respectively). Although TEAEs and TE-SAEs were numerically higher with PRV-300 than placebo (50.0% vs 11.1% and 39.3% vs 0.0%, respectively), the drug was well-tolerated, with only 7.1% (2/28) discontinuing therapy due to AEs and most events being mild, non-specific, or related to underlying disease. In colonic biopsies, PRV-300 had a greater, albeit not statistically significant, effect on the downregulation of TLR3 expression, but not on a UC gene expression signature. No differences in MCS and endoscopic severity were observed.
conclusionsWhile PRV-300 demonstrated an acceptable safety profile, TLR3 blockade did not translate into clinical benefit despite exploratory evidence of target engagement. Our results are challenging a pivotal role of the mode-of-action for the pathogenesis of UC (funded by Provention Bio). CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03849599).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.