Study to Assess SLN124 in Patients With Polycythemia Vera
Condition(s) studied
Investigational drug(s) / intervention(s)
SLN124: SLN124 is a double-stranded small interfering ribonucleic acid (siRNA) targeting transmembrane protease, serine 6 (TMPRSS6) messenger ribonucleic acid (mRNA).
Placebo: sodium chloride, solution for injection
Study summary
This is a Phase 1/2, multicenter study with an open-label dose escalation followed by a randomized placebo controlled and double-blind phase of SLN124 in adult patients with Polycythemia Vera (PV) to assess the safety, tolerability, efficacy, pharmacokinetic (PK), and Pharmacodynamic (PD) response of SLN124.
Eligibility
Primary outcome measure(s)
- Phase 1: Incidence of treatment-emergent adverse events (AEs) — Day 239
Safety and tolerability will be reported separately following open-label dose escalation phase and double-blind phase - Phase 1: Assessment of the number of phlebotomies at intervals — 6 months prior to dosing to Day 239
- Phase 2: Proportion of patients who achieve response between week 18 and week 36 (placebo controlled double blind phase) — 18 to 36 weeks
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Hammond | Louisiana | |
| Research Site | Buffalo | New York | |
| Research Site | New York | New York | |
| Research Site | Columbus | Ohio | |
| Research Site | Huntsville | Texas | |
| Research Site | Benowa | Australia | |
| Research Site | Hobart | Australia | |
| Research Site | Kurralta Park | Australia | |
| Research Site 2 | Melbourne | Australia | |
| Research Site | Melbourne | Australia | |
| Linear Clinical Research | Nedlands | Australia | |
| Research Site | Richmond | Australia | |
| Research Site 2 | Plovdiv | Bulgaria | |
| Research Site | Plovdiv | Bulgaria | |
| Research Site | Toronto | Canada | |
| Research Site | Freiburg im Breisgau | Germany | |
| Research Site | Hanover | Germany | |
| Research Site | Alessandria | Italy | |
| Research Site | Meldola | Italy | |
| Research Site | Johor Bahru | Malaysia | |
| Research Site | Kuala Terengganu | Malaysia | |
| Research Site | Kuantan | Malaysia | |
| Research Site | Kuching | Malaysia | |
| Research Site | Gdansk | Poland | |
| Research Site | Katowice | Poland | |
| Research Site | Lublin | Poland | |
| Research Site | Barcelona | Spain | |
| Research Site | Madrid | Spain |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05499013 on ClinicalTrials.gov ↗ ← All trials in Spain