Trial · NCT07569081
A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome
NCT07569081, Phase 2, Phase 3, Not yet recruiting, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome. Trials, record NCT07569081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07569081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome
- NCT number
- NCT07569081
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 136 participants, estimated
- Lead sponsor
- GlaxoSmithKline
- Conditions
- VEXAS Syndrome
- Interventions
- Momelotinib, Glucocorticoids, Placebo
- First posted
- 2026-05-06
- Last updated
- 2026-06-01
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR (Objective response rate) at Week 26 | At Week 26 | ORR is defined as the proportion of participants who have achieved complete response (CR) or partial response (PR) during the 26-week Primary Treatment Period. |
| Secondary | Phase 2: Percentage of participants with partial response (PR) or complete response (CR) at Week 26 | At Week 26 | Percentage of participants with PR or CR at Week 26 to support identification of the Recommended Phase 3 dose (RP3D) |
| Secondary | Phase 2: Number of participants with adverse events and clinically significant changes in laboratory parameters, and vital signs to support identification of the RP3D | Up to 26 Weeks | |
| Secondary | Phase 2: Plasma concentrations of momelotinib and metabolite of momelotinib 21 (M21) to support identification of the RP3D | Up to 26 Weeks | |
| Secondary | Number of flare-free days | Up to 26 Weeks | Flare-free days are calendar days without clinical evidence of VEXAS flare and without treatment escalation. Total number of flare-free days is defined as the cumulative number of consecutive and non-consecutive flare-free days. |
| Secondary | Duration of response (DoR) | Up to 104 Weeks | DoR defined as the date of clinical response (CR or PR) to the date of relapse. |
| Secondary | Number of flare-free days with glucocorticoid (GC) dose <=10 mg/day | Up to 104 Weeks | Flare-free days are calendar days without clinical evidence of VEXAS flare and without treatment escalation. Total number of flare-free days is defined as the cumulative number of consecutive and non-consecutive flare-free days. |
| Secondary | Percentage of participants achieving complete and partial biochemical response | Up to 26 Weeks | Complete biological response is defined as complete or partial normalization of C-reactive protein. |
| Secondary | Objective response rate (ORR) at Week 52 | At Week 52 | ORR is defined as the proportion of participants who have achieved complete response or partial response |
| Secondary | Number of Participants with Hematologic Improvement- Erythroid (HI-E) response per International Working Group (IWG) 2018 criteria | Up to 26 Weeks | HI-E response is measured based on the combined incidence of: Low transfusion burden participants defined as absence of any transfusion for greater than or equal to (\>=)8 consecutive weeks. High transfusion burden participants: minor response defined as reduction by \>=50% of red blood cell (RBC) units for \>=8 consecutive weeks. Major response defined as absence of RBC transfusions for \>=8 consecutive weeks or longer up to 26 weeks. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 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/NCT07569081
GET https://conductscience.org/api/trials/v1/NCT07569081/registered?page=2