At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pacritinib (drug), Placebo (drug)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Pacritinib — drug: Supplied in hard capsules. · Placebo — drug: Supplied in hard capsules.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 156
- Started
- 2025-05-28
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for vexas
- • Phase2 - 156 participants
- • This trial is to assess the effectiveness and safety of pacritinib in patients with VEXAS (i
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with vexas
Where?
- • Leeds - St James's University Hospital
- • London - Royal Free Hospital
- • London - King's College Hospital, Department of Hematology
- • Oxford - Churchill Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This trial is to assess the effectiveness and safety of pacritinib in patients with VEXAS (i.e., Vacuoles in myeloid progenitors, E1 ubiquitin-activating enzyme, X-linked, autoinflammatory manifestations, and somatic) syndrome. In phase 2a, approximately 78 participants will be randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. In Phase 2b, approximately 78 participants will be randomized. Phase 2b participants will initially be randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. After dose selection, Phase 2b further participants will be randomized to either the selected pacritinib dose or placebo. Randomization will be stratified by prescribed GC dose on the day of randomization.
More detail
This trial is a randomized, multicenter, double-blind, placebo-controlled phase 2a and 2b trial designed to evaluate the efficacy and safety of pacritinib for the prevention of VEXAS flares after glucocorticoid (GC) taper. The trial will enroll participants ≥18 years with inflammatory VEXAS syndrome receiving ongoing GC therapy for ≥4 consecutive weeks, requiring between 15 and 45 mg daily (of prednisone / prednisolone or equivalent) at the time of enrollment (randomization). In phase 2a, participants will be randomized 1:1:1 to receive pacritinib dose A (n=26), pacritinib dose B plus placebo (n=26), or placebo (n=26) for up to 24 weeks during a double-blind treatment period, followed by treatment with pacritinib during an open-label treatment period for up to 48 weeks. In Phase 2b, approximately 78 participants will be randomized (enrollment starts after completion of Phase 2a enrollment). Randomization will initially be conducted in a 1:1:1 ratio to receive pacritinib dose A, pacritinib dose B plus placebo, or placebo, consistent with Phase 2a. Following Phase 2a results, a single pacritinib dose will be selected for continued evaluation. After dose selection, Phase 2b further participants will be randomized in a 2:1 ratio of the selected pacritinib dose to placebo until the total target of 78 participants are randomized. Randomization will be stratified by prescribed GC dose on the day of randomization. All outcomes will be reported by treatment arm, and comparisons between each pacritinib arm and placebo (Phase 2a) or between the selected pacritinib dose and placebo (Phase 2b) will be performed in the double-blind treatment periods. Participants who complete the double-blind treatment period at EOW 24 or meet Early Failure criteria at EOW 12 will transition to an open-label pacritinib treatment period through EOW 48. In addition, if a trial arm closes (due to interim futility or safety in Phase 2a or due to dose selection in Phase 2b), all participants currently randomized to the terminated arm will transition to open-label treatment. Participants who complete the open-label treatment period at End of Week (EOW) 48 and who are benefitting from pacritinib in the opinion of the Investigator may continue to receive treatment for an additional 2 years on the extension period. Participants who discontinue study treatment will have a 30-day post-End of Treatment (EOT) follow-up period. The trial (including the double-blind and open-label treatment periods, as well as the extension period) is planned to end approximately 3 years from the first dose of the last participant.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative serum pregnancy test within 30 days
What the study is looking for
- ✓Receiving ongoing GC therapy (stable prednisone or prednisolone dose of 15-45 mg/day) leading up to enrollment.
- ✓Good overall fitness (Karnofsky 50)%
- ✓healthy organ, meeting all the following criteria within 30 days prior to enrollment:
- ✓Aspartate aminotransferase (liver enzymes) and alanine aminotransferase (liver enzymes) ≤3 × upper limit of normal (ULN)
- ✓Total liver blood test ≤4 × ULN (≤8 × ULN in the setting of Gilbert's syndrome)
See the full criteria
Where Is This Study? (4 UK sites)
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
King's College Hospital, Department of Hematology
London SE5 9RS, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
