Trial · NCT06782373
A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)
NCT06782373, Phase 2, Recruiting, Swedish Orphan Biovitrum
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS). Trials, record NCT06782373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06782373
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)
- NCT number
- NCT06782373
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 156 participants, estimated
- Lead sponsor
- Swedish Orphan Biovitrum
- Conditions
- VEXAS, VEXAS Syndrome
- Interventions
- Pacritinib, Placebo
- First posted
- 2025-01-17
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR), defined as achieving Partial Clinical Response or better at any time during the double-blind treatment period. | up to End of Week 24 | Difference in the proportion of participants achieving ORR for the pairwise comparison of pacritinib dose A vs. placebo and pacritinib dose B plus placebo vs. placebo (Phase 2a) and selected pacritinib dose compared to placebo (Phase 2b) |
| Secondary | Overall Clinical Response (OCR), defined as achieving Clinical Response or better at any time during the double-blind treatment period | up to End of Week 24 | Difference in the proportion of participants achieving OCR for the pairwise comparison of pacritinib dose A vs. placebo and pacritinib dose B plus placebo vs. placebo (Phase 2a) and selected pacritinib dose compared to placebo (Phase 2b) |
| Secondary | Number of flare-free days with GC dose ≤10 mg | up to End of Week 24 | |
| Secondary | Proportion of participants on each arm achieving each Best Response category (Clinical Biochemical Response, Clinical Response, Partial Clinical Response, Stable Disease, or Non-response). | up to End of Week 24 | |
| Secondary | Hematologic Improvement - Erythroid | up to End of Week 24 | Erythroid (HI-E) at any time among participants with baseline hemoglobin \<10 g/dL per modified International Working Group (IWG) criteria |
| Secondary | Hematologic Improvement - Platelets | up to End of Week 24 | Platelets (HI-P) at any time among participants with baseline platelet count \<100 × 10\^9/L per modified IWG criteria |
| Secondary | Change in health-related quality of life (QOL) as measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS) fatigue short form | up to End of Week 24 | The PROMIS short form domains of fatigue 4a will be summarized, raw score from 4 to 20 (T-score from 33.7 to 75.8). A higher score is associated with more fatigue. |
| Secondary | Change in health-related QOL as measured by PROMIS physical function short form | up to End of Week 24 | The PROMIS short form domains of physical function 4a will be summarized, raw score from 4 to 20 (T-score from 22.5 to 57.0). A higher score is associated with better physical function. |
| Secondary | Change in health-related QOL as measured by PROMIS sleep disturbance short form | up to End of Week 24 | The PROMIS short form domains of sleep disturbance 4a will be summarized, raw score from 4 to 20 (T-score from 32.0 to 73.3). A higher score is associated with more sleep disturbance. |
| Secondary | Change in health-related QOL as measured by the 36-item short form (SF) Survey | up to End of Week 24 | The SF-36 Survey measures eight domains of health status; physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. The values for each domain range from 0 to 100, with the higher score indicating a better health status. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41753113 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06782373
GET https://conductscience.org/api/trials/v1/NCT06782373/registered