VEXAS SyndromePhase 2/3ATLASNCT07569081
A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome
A Phase 2/3 study testing Momelotinib and Glucocorticoids in people with VEXAS Syndrome, run by GlaxoSmithKline.
Trial summary
This study will assess the efficacy and safety of momelotinib in participants with a diagnosis of VEXAS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VEXAS Syndrome
- What is being tested?
- Momelotinib and Glucocorticoids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2026to 4 Jun 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than equal to (>=)18 years OR of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the Informed Consent Form.
- Confirmed diagnosis of clinical VEXAS defined by:
- Documented evidence of a canonical, pathogenic Ubiquitin-like modifier activating enzyme 1 (UBA1) mutation
- Inflammatory manifestations: current or documented past involvement within 6 months of at least one organ system
- Receiving glucocorticoid (GC) treatment (prednisone/prednisolone) for >=4 consecutive weeks for >=10 days prior to randomization.
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
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- Is a Participant of non-childbearing potential (PONCBP) OR
- Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective
- Is capable of giving signed informed consent including compliance with the requirements and restrictions
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at the time of screening.
- Has adequate organ function
Who cannot join
- More than 1 prior admission to an intensive care unit due to a VEXAS flare within the 6 months prior to randomization.
- History of severe corticosteroid toxicity: uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries, nausea or vomiting or gastrointestinal disease.
- High risk/very high risk Myelodysplastic syndrome (MDS), according to the Revised International Prognostic Scoring System (IPSS-R) with overall risk score >3.5.
- Peripheral blood blast counts >=10%.
- Multiple myeloma (all stages) and other active plasma cell dyscrasias requiring treatment.
- Malignancy (except disease under study including Lower-risk myelodysplastic syndrome [LR-MDS]) that has progressed or required active treatment within the past (24 months) except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas).
Show all 36Show fewer
- Uncontrolled intercurrent illness within 12 weeks prior to initiation of momelotinib.
- Ongoing adverse reaction(s) from prior therapy that have not recovered to Grade <=1 per NCI CTCAE v6.0 or to the Baseline status preceding prior therapy
- Psychiatric illness, social situation, or any other condition that would limit informed consent and/or compliance with trial requirements or may interfere with the interpretation of study results, as judged by Investigator or Sponsor.
- Has any clinically significant gastrointestinal conditions or abnormalities that may alter absorption or swallowing
- Known contraindication or hypersensitivity to momelotinib and its metabolites, or any of their excipients.
- Presence of peripheral neuropathy >=Grade 2 per NCI CTCAE v6.0.
- Known history of disseminated mycobacterial infection.
- Known positive status for human immunodeficiency virus (HIV).
- Positive QuantiFERON (or other interferon gamma release assay) during Screening.
- Unable to receive any Pneumocystis jiroveci pneumonia (PJP) medical prophylaxis
- Known clinically significant anemia due to iron, vitamin B12 or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia.
- More than 1 prior line of VEXAS directed therapy before or after VEXAS diagnosis or other medical condition.
- Use of the following treatments within the noted time periods referenced from date of randomization:
- VEXAS-directed therapies (washout period) up to 5 half-lives or up 14 days if half-life is <3 days
- Other non-GC anti-inflammatory therapies: for non-biologics): 14 days or five half-lives, whichever is longer; for biologics): 28 days or two half-lives whichever is longer.
- Hematologic support therapy (e.g., ESAs, danazol, luspatercept, G-CSF): 4 weeks
- Cell-depleting therapies such as anti-CD20 (rituximab): 12 months
- Investigational agent from a class not otherwise specified: 5 half-lives or 60 days, whichever is longer
- GC use for conditions other than VEXAS, which would interfere with adherence to the fixed GC taper regimen and/or to assessment of efficacy.
- Chronic use of systemic corticosteroids for >4 years or inability to withdraw corticosteroid treatment
- Planned allogeneic HSCT for MDS or VEXAS, within 1 year.
- Any major surgery within 28 days prior to randomization.
- Prior allogeneic/autologous stem cell transplant or solid organ transplant (other than corneal).
- Presence of peripheral neuropathy >=Grade 2 per NCI CTCAE v6.0.
- Hepatitis B or C active infection, unless protocol defined criteria are met.
- Any of the following conditions within 6 months prior to randomization:
- Unstable angina pectoris
- Symptomatic congestive heart failure
- Uncontrolled cardiac arrhythmia
- QTc >450 msec or QTc >480 msec for participants with bundle branch block.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Phase 2/3, Double-blind, Placebo Controlled Adaptive Study Evaluating the Efficacy and Safety of Momelotinib in Participants With VEXAS Syndrome
This study will assess the efficacy and safety of momelotinib in participants with a diagnosis of VEXAS.
- Conditions
- VEXAS Syndrome
- Being tested
- Momelotinib, Glucocorticoids, Placebo
- Keywords
- VEXAS Syndrome, Momelotinib, Adaptive, Ubiquitin-like modifier activating enzyme 1 mutation, ATLAS
- Medical subject headings
- VEXAS syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MomelotinibDrug
Also called GSK3070785
Momelotinib will be administered
GlucocorticoidsDrug
Glucocorticoids (prednisone or prednisolone) will be administered
PlaceboDrug
Placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| Momelotinib Dose level 1 + Glucocorticoids | Experimental | Participants will receive momelotinib at dose level 1 along with glucocorticoids as a background therapy (prednisone or prednisolone). Due to adaptive design of the study, additional participants may be randomized to this arm in phase 3. Receives: Drug: Momelotinib; Drug: Glucocorticoids |
| Momelotinib Dose level 2 + Glucocorticoids | Experimental | Participants will receive momelotinib at dose level 2 along with glucocorticoids as a background therapy (prednisone or prednisolone). Due to adaptive design of the study, additional participants may be randomized to this arm in phase 3 Receives: Drug: Momelotinib; Drug: Glucocorticoids |
| Placebo + Glucocorticoids | Placebo comparator | Participants will receive momelotinib matched placebo along with glucocorticoids as a background therapy(prednisone or prednisolone). Due to adaptive design of the study, additional participants may be randomized to this arm in phase 3 Receives: Drug: Glucocorticoids; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (Objective response rate) 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.
Measured: At Week 26
Secondary outcomes (22)
Phase 2: Percentage of participants with partial response (PR) or complete response (CR) at Week 26
Percentage of participants with PR or CR at Week 26 to support identification of the Recommended Phase 3 dose (RP3D)
Measured: At Week 26
Phase 2: Number of participants with adverse events and clinically significant changes in laboratory parameters, and vital signs to support identification of the RP3D
Measured: Up to 26 Weeks
Phase 2: Plasma concentrations of momelotinib and metabolite of momelotinib 21 (M21) to support identification of the RP3D
Measured: Up to 26 Weeks
Number of flare-free days
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.
Measured: Up to 26 Weeks
Duration of response (DoR)
DoR defined as the date of clinical response (CR or PR) to the date of relapse.
Measured: Up to 104 Weeks
Number of flare-free days with glucocorticoid (GC) dose <=10 mg/day
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.
Measured: Up to 104 Weeks
Percentage of participants achieving complete and partial biochemical response
Complete biological response is defined as complete or partial normalization of C-reactive protein.
Measured: Up to 26 Weeks
Objective response rate (ORR) at Week 52
ORR is defined as the proportion of participants who have achieved complete response or partial response
Measured: At Week 52
Number of Participants with Hematologic Improvement- Erythroid (HI-E) response per International Working Group (IWG) 2018 criteria
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.
Measured: Up to 26 Weeks
Change from Baseline in Short Form 36 (SF-36) domain and summary scores
Short-Form 36 is a health-related survey that assesses quality of life covering 8 domains: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; and mental health. The domain scores are weighted to a scale ranging between 0 to 100, where higher score represents better health. The Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are derived from the eight domain scores. These scores are standardized to a general U.S. population average of 50, with a standard deviation of 10. For both PCS and MCS, scores range from 0 to 100, higher scores indicate a better health outcome.
Measured: Baseline and up to Week 48
Change from Baseline in European Organization for Research and Treatment of Cancer Item Library (EORTC IL) 479 score
The EORTC Item Library is a database containing >1000 individual items from more than 70 EORTC quality of life measures. A subset of 7 items from the library were selected based on symptoms experienced by participants with VEXAS syndrome. Scores range from 1 to 100 with higher scores representing a higher ("worse") level of symptoms.
Measured: Baseline and up to Week 156
Change From Baseline in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function Short Form 10b
PROMIS Physical Function Short Form 10b consists of 10 questions; each with a 5-point response. PROMIS short form assesses self-reported capability of a participant rather than actual performance of physical activities. Higher scores indicate better functioning. Total possible range of scores is 10 to 50, with higher scores corresponding to a greater physical function ability.
Measured: Baseline and up to Week 156
Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-FATIGUE)
The FACIT-Fatigue is a short, 13-item questionnaire that assesses self-reported fatigue and its associated impact on daily activities over the past 7 days. A higher score indicates a better outcome (no fatigue). The total score ranges from 0 to 52, with 0 being the worst possible score and 52 being the best possible score (indicating no fatigue).
Measured: Baseline and up to Week 156
Changes from Baseline in Patient Global Impression of Severity (PGIS) scores
The PGIS is a single global question which asks participants to rate the severity of their VEXAS syndrome symptoms on a 5-point rating scale with response categories of "No symptoms", "Mild", "Moderate", "Severe", and "Very Severe." The PGIS scores ranges from 0 (absent) to 4 (very severe).
Measured: Baseline and up to Week 156
Changes in Patient Global Impression of Change (PGIC) scores
The PGIC is a single global question which asks participants to rate the change in severity of their VEXAS syndrome symptoms since starting study medication using a 5-point rating scale with response categories of "much better", "a little better", "no change", "a little worse", "much worse". The PGIC score ranges from +2 (much better) to -2 (much worse).
Measured: Baseline and up to Week 156
Changes from Baseline in European quality of life 5 dimensions 5 level version (EQ-5D-5L)
EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by 5-point Likert scale ranging from 1=no problems to 5=extreme problems.
Measured: Baseline and up to Week 48
Changes from Baseline in European quality of life-Visual Analogue Scale (EQ-VAS)
The EQ-VAS records the respondents self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health.
Measured: Baseline and up to Week 48
Number of participants with adverse events (AEs) and Serious adverse events (SAEs)
Measured: Up to Week 108
Number of participants with adverse events (AEs) and Serious adverse events (SAEs) by severity
Measured: Up to Week 108
Number of participants with AEs leading to discontinuation or dose modifications
Measured: Up to Week 108
Plasma concentration of momelotinib and M21
Measured: Up to 26 Weeks
Overall Survival
Overall survival is defined as the time from randomization to the date of death due to any cause.
Measured: At Months 12, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start5 Aug 2026 (estimated)
- Primary completion6 Dec 2028 (estimated)
- Study completion4 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VEXAS SyndromeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569081
- Sponsor's protocol ID
- 223401
- Other IDs
- 2025-524416-11-00, 2025
- Acronym
- ATLAS
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2/3, Double-blind, Placebo Controlled Adaptive Study Evaluating the Efficacy and Safety of Momelotinib in Participants With VEXAS Syndrome
- ClinicalTrials.gov ID
- NCT07569081
- Acronym / sponsor ID
- ATLAS / 223401
- Conditions
- VEXAS Syndrome
- Keywords
- VEXAS Syndrome, Momelotinib, Adaptive, Ubiquitin-like modifier activating enzyme 1 mutation, ATLAS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 6 Dec 2028 (estimated)
- Study completion
- 4 Jun 2031 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of momelotinib in participants with a diagnosis of VEXAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Momelotinib Dose level 1 + Glucocorticoids | Experimental | Drug: Momelotinib, Drug: GlucocorticoidsParticipants will receive momelotinib at dose level 1 along with glucocorticoids as a background therapy (prednisone or prednisolone). Due to adaptive design of the study, additional participants may be randomized to this arm in phase 3. |
| Momelotinib Dose level 2 + Glucocorticoids | Experimental | Drug: Momelotinib, Drug: GlucocorticoidsParticipants will receive momelotinib at dose level 2 along with glucocorticoids as a background therapy (prednisone or prednisolone). Due to adaptive design of the study, additional participants may be randomized to this arm in phase 3 |
| Placebo + Glucocorticoids | Placebo comparator | Drug: Glucocorticoids, Drug: PlaceboParticipants will receive momelotinib matched placebo along with glucocorticoids as a background therapy(prednisone or prednisolone). Due to adaptive design of the study, additional participants may be randomized to this arm in phase 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age greater than equal to (>=)18 years OR of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the Informed Consent Form.
- Confirmed diagnosis of clinical VEXAS defined by:
- Receiving glucocorticoid (GC) treatment (prednisone/prednisolone) for >=4 consecutive weeks for >=10 days prior to randomization.
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- Is capable of giving signed informed consent including compliance with the requirements and restrictions
Key exclusion criteria (36 listed)
- More than 1 prior admission to an intensive care unit due to a VEXAS flare within the 6 months prior to randomization.
- History of severe corticosteroid toxicity: uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries, nausea or vomiting or gastrointestinal disease.
- High risk/very high risk Myelodysplastic syndrome (MDS), according to the Revised International Prognostic Scoring System (IPSS-R) with overall risk score >3.5.
- Peripheral blood blast counts >=10%.
- Multiple myeloma (all stages) and other active plasma cell dyscrasias requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MomelotinibAlso: GSK3070785Momelotinib will be administered | Drug | Momelotinib Dose level 1 + Glucocorticoids, Momelotinib Dose level 2 + Glucocorticoids |
| GlucocorticoidsGlucocorticoids (prednisone or prednisolone) will be administered | Drug | Momelotinib Dose level 1 + Glucocorticoids, Momelotinib Dose level 2 + Glucocorticoids, Placebo + Glucocorticoids |
| PlaceboPlacebo will be administered | Drug | Placebo + Glucocorticoids |
Primary outcome
ORR (Objective response rate) at Week 26
Time frame: 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.
22 secondary outcomes
Phase 2: Percentage of participants with partial response (PR) or complete response (CR) at Week 26
Time frame: At Week 26
Phase 2: Number of participants with adverse events and clinically significant changes in laboratory parameters, and vital signs to support identification of the RP3D
Time frame: Up to 26 Weeks
Phase 2: Plasma concentrations of momelotinib and metabolite of momelotinib 21 (M21) to support identification of the RP3D
Time frame: Up to 26 Weeks
Number of flare-free days
Time frame: Up to 26 Weeks
Duration of response (DoR)
Time frame: Up to 104 Weeks
Number of flare-free days with glucocorticoid (GC) dose <=10 mg/day
Time frame: Up to 104 Weeks
Percentage of participants achieving complete and partial biochemical response
Time frame: Up to 26 Weeks
Objective response rate (ORR) at Week 52
Time frame: At Week 52
Number of Participants with Hematologic Improvement- Erythroid (HI-E) response per International Working Group (IWG) 2018 criteria
Time frame: Up to 26 Weeks
Change from Baseline in Short Form 36 (SF-36) domain and summary scores
Time frame: Baseline and up to Week 48
Change from Baseline in European Organization for Research and Treatment of Cancer Item Library (EORTC IL) 479 score
Time frame: Baseline and up to Week 156
Change From Baseline in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function Short Form 10b
Time frame: Baseline and up to Week 156
Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-FATIGUE)
Time frame: Baseline and up to Week 156
Changes from Baseline in Patient Global Impression of Severity (PGIS) scores
Time frame: Baseline and up to Week 156
Changes in Patient Global Impression of Change (PGIC) scores
Time frame: Baseline and up to Week 156
Changes from Baseline in European quality of life 5 dimensions 5 level version (EQ-5D-5L)
Time frame: Baseline and up to Week 48
Changes from Baseline in European quality of life-Visual Analogue Scale (EQ-VAS)
Time frame: Baseline and up to Week 48
Number of participants with adverse events (AEs) and Serious adverse events (SAEs)
Time frame: Up to Week 108
Number of participants with adverse events (AEs) and Serious adverse events (SAEs) by severity
Time frame: Up to Week 108
Number of participants with AEs leading to discontinuation or dose modifications
Time frame: Up to Week 108
Plasma concentration of momelotinib and M21
Time frame: Up to 26 Weeks
Overall Survival
Time frame: At Months 12, 24 and 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Momelotinib and Glucocorticoids in people with VEXAS Syndrome, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (Objective response rate) at Week 26 (time frame: At Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.