ONO-0530-03-001
Research type
Research Study
Full title
A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera.
IRAS ID
1013770
Contact name
Priyankha Kamath
Contact email
Sponsor organisation
Ono Pharmaceutical Co., Ltd [sponsor representative: Deciphera Pharmaceuticals LLC (a member of Ono Pharma)]
Eudract number
2025-524669-25
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Research summary
This trial will include adults with PV who may or may not be taking CRT but still need phlebotomies to help control their PV. People cannot take part if they have received certain medications for PV in the past. People also cannot take part if they have certain medical conditions or take certain medications that could make it unsafe for them to participate or affect the trial results. A trial doctor will review each person’s medical history and medications before they join to see if they can take part. This trial will happen in 3 parts. All participants will enter Part 1a. Participants who complete Part 1a may enter Part 1b. After they complete Part 1b, they may enter Part 2. Participants who complete all parts may be in the trial for just over 3 years: Part 1a: Participants will receive either sapablursen or a placebo for almost 8 months. A placebo is an identical-looking treatment with no active trial drug in it. Some clinical trials use a placebo because this lets researchers compare results in a group that got the trial treatment to results in a group that did not. Those who do not get the trial treatment still follow the same steps and receive the same care. Any differences observed between these 2 groups are more likely to be due to the actual effects of the trial treatment. Researchers will use a computer program to randomly assign which treatment participants will receive in Part 1a. This helps make sure the treatments are assigned without bias to individual participants. None of the participants, trial doctors, or others involved in reviewing the results will know which treatment each participant is receiving in this part. Some trials are done this way because knowing what treatment a participant is receiving can affect the results. Part 1b: Participants who received a placebo in Part 1a will have the opportunity to receive sapablursen. Participants who received sapablursen in Part 1a will have the opportunity to continue treatment.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
26/EM/0087
Date of REC Opinion
16 Jun 2026
REC opinion
Further Information Favourable Opinion