SLN124 for Polycythemia Vera (SLN Trial)

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Silence Therapeutics plc

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called SLN124 in adults with Polycythemia Vera, a condition where the body makes too many red blood cells. The study aims to see if SLN124 is safe and effective. Researchers will also look at how the drug moves through and affects the body.

Will I have to stop taking my current medications?

If you are not on cytoreductive therapy, you must have stopped any previous cytoreductive medications at least 24 weeks before starting the trial. If you are on cytoreductive therapy like hydroxyurea, interferon, busulfan, or ruxolitinib, you need to be on a stable dose for at least 12 weeks before starting the trial.

Eligibility Criteria

Adults with Polycythemia Vera (PV) who've had a skin check in the last 6 months, meet specific PV diagnostic criteria, and have stable phlebotomy history. They must not be on or have recently used certain drugs for PV, agree to contraception, and have an acceptable level of physical functioning.

Participant Groups

The study is testing SLN124 against a placebo in patients with PV. It starts with an open-label phase where everyone gets SLN124 to find safe doses, followed by a randomized phase where participants are blindly given either SLN124 or a placebo to compare effects.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase 2 Blinded SLN124Experimental Treatment1 Intervention

SLN124 for subcutaneous (s.c.) injection

Group II: Phase 1 open-label SLN124Experimental Treatment1 Intervention

SLN124 for subcutaneous (s.c.) injection

Group III: Phase 2 Blinded PlaceboPlacebo Group1 Intervention

Sodium chloride for s.c. injection