Trial · NCT07098936
Momelotinib in VEXAS Syndrome
NCT07098936, Phase 2, Recruiting, Groupe Francophone des Myelodysplasies
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Momelotinib in VEXAS Syndrome. Trials, record NCT07098936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07098936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Momelotinib in VEXAS Syndrome
- NCT number
- NCT07098936
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 57 participants, estimated
- Lead sponsor
- Groupe Francophone des Myelodysplasies
- Conditions
- VEXAS Syndome, Myelo Dysplastic Syndrome
- Interventions
- Momelotinib treatment
- First posted
- 2025-08-01
- Last updated
- 2026-08-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of the maximum tolerated dose of momelotinib | First 4-week cycle of momelotinib treatment | The maximum tolerated dose (MTD) is defined by a target dose-limiting toxicities (DLT) rate of 30%, assessed during the observation window by a 3+3 design. The 3+3 design will enroll a first cohort of 3 patients at the starting dose of 200 mg/d: * If 0 of the 3 patients at the dose of 200 mg/d experienced a DLT during the first 4-week cycle of momelotinib, the dose will escalate to 300 mg/d for the next cohort. * If 1 of the 3 patients at the dose of 200 mg/d has a DLT, a cohort of three additional patients will be treated at the same dose of 200 mg/d. * If \> 1 patient of the 3 patients at the dose of 200 mg/d have a DLT, the dose will de-escalate to 150 mg/d for the next cohort. The same process will be repeated until reaching the MTD. In total, between 6 and 18 patients will be enrolled during this safety run-in phase. |
| Primary | Clinical efficacy | During the 24 first weeks of momelotinib treatment | Determination of overall clinical response rate at 24 weeks after momelotinib initiation on VEXAS related symptoms (including complete (CR) or partial response (PR)) : * CR includes complete disappearance of symptoms related to systemic inflammation according to treating physician and daily dose of steroids ≤ 10 mg/d (equivalent prednisolone). * PR includes complete disappearance of symptoms related to systemic inflammation according to treating physician and reduction of at least 50% of daily dose steroids compared to baseline and/or daily dose of steroids \> 10 mg/d. |
| Secondary | Pharmacokinetic | At cycle 1 Day 8-9 and cycle 13 Day 8-9 | Concentrations of momelotinib and its major metabolite M21 will be determined in plasma samples using the currently approved bioanalytical methodology by Frontage Laboratories Inc. Pharmacokinetic sampling will be only performed for patients in safety run-in phase. Samples should be obtained at cycle 1 Day 8 and cycle 13 Day 8, at times following : Pre-dose then at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8h and at 24 h post Day 8 dose. |
| Secondary | Incidence of Treatment-Emergent Adverse Events | From enrollment to the end of treatment at 48 weeks | Collection of Adverse events (AE), serious AE (SAE) and toxicities as measured by NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 |
| Secondary | Response | After 4, 12, 24 and 48 weeks of momelotinib treatment | Determination of overall clinical response rates (including Complete Response or Partial Response) and biological response rates (complete or partial) |
| Secondary | Hematological response | After 16 weeks of momelotinib treatment | Erythroid hematological improvement will be assessed by the investigators according to IWG 2018 criteria through collection of transfusion records and hematology parameters. |
| Secondary | Steroids dose reduction | After 24 weeks of momelotinib treatment | Steroids dose reduction compared to baseline and/or steroids withdrawal rates |
| Secondary | Overall survival | From enrollment to the end of treatment at 12 months | Overall survival assessment |
| Secondary | Myelodysplastic syndrome (MDS) evolution | From baseline at 12 and 24 weeks of momelotinib treatment | Changes in the underlying MDS from baseline, at 12 and 24 weeks, including MDS progression based on hematological, cytogenetic and molecular analysis |
| Secondary | Duration of response | From enrollment to the end of treatment at 48 weeks | Duration of response on VEXAS symptoms defined as the time from the date of initial documentation of a clinical response (Complete Response or Partial Response) to the date of first documented evidence of relapse or death |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07098936
GET https://conductscience.org/api/trials/v1/NCT07098936/registered