Autoimmune Hemolytic AnemiaPhase 2NCT03538041
A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
A Phase 2 study testing Parsaclisib in people with Autoimmune Hemolytic Anemia, run by Incyte Corporation at 12 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hemolytic Anemia
- What is being tested?
- Parsaclisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 21 Nov 2018to 2 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test.
- Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
- Hemoglobin 7 to 10 g/dL.
- No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Pregnant or breastfeeding women.
- Concurrent conditions and history of other protocol-specified diseases.
- ANC < 1.5 × 10^9/L.
- Platelet count < 100 × 10^9/L.
- Severely impaired liver function.
- Impaired renal function with estimated creatinine clearance less than 45 mL/min.
Show all 11Show fewer
- Anti-phospholipid antibodies positive or elevated anti-streptolysin antibodies.
- Positive serology test results for hepatitis B surface antigen or core antibody, or hepatitis C virus antibody with detectable RNA at screening, consistent with active or chronic infection.
- Known HIV infection or positivity on immunoassay.
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
- Known hypersensitivity or severe reaction to parsaclisib or its excipients.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States6 sites
University Health System Inc., Dba the University of Tn Medical Center
Knoxville, Tennessee, 37920
University of Minnesota
Minneapolis, Minnesota, 55455
Weill Medical College of Cornell University
New York, New York, 10021
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Italy3 sites
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122
UNIVERSIT� DI NAPOLI FEDERICO II
Naples, 80131
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARIT� DI NOVARA
Novara, 28100
France2 sites
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
Centre Hospitalier Regional Universitaire (Chru) de Lille
Lille, 59037
About this study
Official title: A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.
- Conditions
- Autoimmune Hemolytic Anemia
- Being tested
- Parsaclisib
- Keywords
- autoimmune hemolytic anemia, phosphatidylinositol 3-kinase (PI3K) inhibitor
- Medical subject headings
- Anemia, Hemolytic, Autoimmune, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
Also called INCB050465
Parsaclisib administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Parsaclisib 1 mg QD | Experimental | Parsaclisib at 1 milligram (mg) once daily (QD) for 12 weeks followed by extension period, with a dose-increase option (to 2.5 mg QD) at Week 6 for participants who fulfill dose increase criteria. Receives: Drug: Parsaclisib |
| Parsaclisib 2.5 mg QD | Experimental | Parsaclisib at 2.5 mg QD for 12 weeks followed by extension period. Receives: Drug: Parsaclisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12
A complete response was defined as hemoglobin >12 grams per deciliter (g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as > 1 week since the last transfusion.
Measured: Week 6 to Week 12
Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12
A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as > 1 week since the last transfusion.
Measured: Week 6 to Week 12
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy, or required changes in the study drug. Anemia and transfusions should not have been reported as AEs unless they represented a clinically meaningful decrease from Baseline in hemoglobin. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Measured: up to 1638 days
Secondary outcomes (23)
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
A complete response was defined as hemoglobin >12 g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as > 1 week since the last transfusion.
Measured: up to 1638 days
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as > 1 week since the last transfusion.
Measured: up to 1638 days
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Hemoglobin levels were assessed throughout the study.
Measured: up to 1638 days
Change From Baseline in Hemoglobin
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to 1638 days
Percentage Change From Baseline in Hemoglobin
Percentage change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Measured: Baseline; up to 1638 days
Percentage of Participants Requiring Transfusions
A participant was defined to have required a transfusion if his or her last transfusion was within 7 days of the visit date.
Measured: Baseline; up to 1638 days
Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin
Normalization was determined by the Investigator based on normal ranges for the clinical reference laboratory.
Measured: up to 1638 days
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Prednisone use was monitored throughout the study.
Measured: up to 1638 days
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores
The FACIT-F subscale is a 13-item instrument designed to assess fatigue/tiredness and its impact on daily activities and functioning in a number of chronic diseases. Participants were asked to respond to 13 statements that people with the illness have said are important on the following scale: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. Participants were asked to indicate the response as it applied to the last 7 days. The total fatigue subscale score ranges from 0 to 52; a higher score indicates more severe impact on daily activities and functioning.
Measured: Baseline; up to 1638 days
Mean Cmax of Parsaclisib
Cmax was defined as the maximum observed concentration. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Measured: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean Tmax of Parsaclisib
tmax was defined as the time to the maximum concentration. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Measured: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean Cmin of Parsaclisib
Cmin was defined as the minimum observed concentration over the dose interval. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Measured: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean AUC0-4 of Parsaclisib
AUC0-4 was defined as the area under the concentration-time curve from time = 0 to 4 hours postdose. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Measured: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean AUC0-t of Parsaclisib
AUC0-t was defined as the area under the concentration-time curve from time = 0 to the last measureable concentration at time = t. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Measured: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean Clast of Parsaclisib
Clast was defined as the last measurable concentration (above the quantification limit). Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Measured: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean Tlast of Parsaclisib
Tlast was defined as the time of the last measurable concentration (above the quantification limit). Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Measured: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Change From Baseline in Reticulocyte Count
Change from Baseline was calculated as the post-Baseline value minus the Baseline value
Measured: Baseline; up to 1638 days
Change From Baseline in Cardiolipin Immunoglobulin G (IgG) Antibody and Cardiolipin Immunoglobulin M (IgM) Antibody
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 12
Change From Baseline in Cold Hemagglutinin Levels
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 12
Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to 1638 days
Change From Baseline in Lactate Dehydrogenase (LDH)
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to 1638 days
Change From Baseline in CH50
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to 1638 days
Change From Baseline in Complement C3 and Complement C4
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to 1638 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start21 Nov 2018
- Primary completion5 Aug 2021
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Butler, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538041
- Sponsor's protocol ID
- INCB 50465-206
- Other IDs
- Parsaclisib, 2017-003652-22, 2017
- Status last verified
- Jul 2025
- First submitted
- 15 May 2018
- Last updated
- 11 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barcellini W, Pane F, Patriarca A, Murakhovskaya I, Terriou L, DeSancho MT, Hanna WT, Leopold L, Rappold E, Szeto K, Wei S, Jager U. Parsaclisib for the treatment of primary autoimmune hemolytic anemia: Results from a phase 2, open-label study. Am J Hematol. 2024 Dec;99(12):2313-2320. doi: 10.1002/ajh.27493. Epub 2024 Oct 22.
PubMed 39435908
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT03538041
- Acronym / sponsor ID
- INCB 50465-206
- Conditions
- Autoimmune Hemolytic Anemia
- Keywords
- autoimmune hemolytic anemia, phosphatidylinositol 3-kinase (PI3K) inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parsaclisib 1 mg QD | Experimental | Drug: ParsaclisibParsaclisib at 1 milligram (mg) once daily (QD) for 12 weeks followed by extension period, with a dose-increase option (to 2.5 mg QD) at Week 6 for participants who fulfill dose increase criteria. |
| Parsaclisib 2.5 mg QD | Experimental | Drug: ParsaclisibParsaclisib at 2.5 mg QD for 12 weeks followed by extension period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test.
- Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
- Hemoglobin 7 to 10 g/dL.
- No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women.
- Concurrent conditions and history of other protocol-specified diseases.
- ANC < 1.5 × 10^9/L.
- Platelet count < 100 × 10^9/L.
- Severely impaired liver function.
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 |
|---|---|---|
| ParsaclisibAlso: INCB050465Parsaclisib administered orally. | Drug | Parsaclisib 1 mg QD, Parsaclisib 2.5 mg QD |
Primary outcome
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12
Time frame: Week 6 to Week 12
A complete response was defined as hemoglobin >12 grams per deciliter (g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as > 1 week since the last transfusion.
Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12
Time frame: Week 6 to Week 12
A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as > 1 week since the last transfusion.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 1638 days
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy, or required changes in the study drug. Anemia and transfusions should not have been reported as AEs unless they represented a clinically meaningful decrease from Baseline in hemoglobin. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
23 secondary outcomes
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Time frame: up to 1638 days
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Time frame: up to 1638 days
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Time frame: up to 1638 days
Change From Baseline in Hemoglobin
Time frame: Baseline; up to 1638 days
Percentage Change From Baseline in Hemoglobin
Time frame: Baseline; up to 1638 days
Percentage of Participants Requiring Transfusions
Time frame: Baseline; up to 1638 days
Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin
Time frame: up to 1638 days
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Time frame: up to 1638 days
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores
Time frame: Baseline; up to 1638 days
Mean Cmax of Parsaclisib
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean Tmax of Parsaclisib
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean Cmin of Parsaclisib
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean AUC0-4 of Parsaclisib
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean AUC0-t of Parsaclisib
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean Clast of Parsaclisib
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Mean Tlast of Parsaclisib
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Change From Baseline in Reticulocyte Count
Time frame: Baseline; up to 1638 days
Change From Baseline in Cardiolipin Immunoglobulin G (IgG) Antibody and Cardiolipin Immunoglobulin M (IgM) Antibody
Time frame: Baseline; Week 12
Change From Baseline in Cold Hemagglutinin Levels
Time frame: Baseline; Week 12
Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin
Time frame: Baseline; up to 1638 days
Change From Baseline in Lactate Dehydrogenase (LDH)
Time frame: Baseline; up to 1638 days
Change From Baseline in CH50
Time frame: Baseline; up to 1638 days
Change From Baseline in Complement C3 and Complement C4
Time frame: Baseline; up to 1638 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39435908Barcellini W, Pane F, Patriarca A, Murakhovskaya I, Terriou L, DeSancho MT, Hanna WT, Leopold L, Rappold E, Szeto K, Wei S, Jager U. Parsaclisib for the treatment of primary autoimmune hemolytic anemia: Results from a phase 2, open-label study. Am J Hematol. 2024 Dec;99(12):2313-2320. doi: 10.1002/ajh.27493. Epub 2024 Oct 22.
- 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. This study is not recruiting at the moment.
Kathleen Butler, MD study director
Incyte Corporation
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parsaclisib in people with Autoimmune Hemolytic Anemia, run by Incyte Corporation at 12 sites in 4 countries.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Italy, France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12 (time frame: Week 6 to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538041, which also lists 1 linked publication.
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 11 Jul 2025.