Interstitial Lung DiseasePhase 2ABCVILDNCT04925375
Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease
A Phase 2 study testing Abatacept in people with Interstitial Lung Disease and Common Variable Immunodeficiency, run by Children's Hospital Medical Center, Cincinnati at 6 sites in United States.
Trial summary
There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Interstitial Lung Disease, Common Variable Immunodeficiency
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Jul 2021to Jul 2028
- Phase
- Phase 2
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of CVID according to the international consensus document (ICON)
- Age 4 years or above
- Serum IgG at least 2 standard deviations below the age adjusted normal
- Decreased serum IgA and/or serum IgM
- Abnormal specific antibody response to immunization
- Exclusion of secondary immunodeficiency
Show all 16Show fewer
- On replacement immunoglobulin for at least 6 months and willing to maintain throughout study
- Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
- Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 3 months of study entry.
- Signed written informed consent
- Willing to allow storage of biological specimens for future use in medical research.
- Female subjects of childbearing potential must agree to an effective form of birth control such as hormone based contraceptive, intrauterine device, condoms/barrier, surgically sterile partner, or abstinence.
- Fertile, non-vasectomized males with a female partner of childbearing potential should use condoms throughout the study and for 3 months after the last dose
- Patients must have completed the abatacept for the treatment of Interstitial Lung Disease in Common Variable Immunodeficiency (ABCVILD) trial
- Patients must have demonstrated positive response to abatacept.
- Patients must provide informed consent to participate in the Extended Treatment Plan.
Who cannot join
- History of hypersensitivity to abatacept or any of its components
- Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months
- Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as >15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months
- Have started or increased any of the following immune modulating drugs within 3 months of enrolling and 3 months from initial CT chest: azathioprine, cyclosporine, tacrolimus, mercaptopurine, methotrexate, mycophenolate mofetil, or sirolimus
- History of HIV infection (positive PCR)
- Chronic untreated hepatitis B or C (positive PCR)
Show all 16Show fewer
- Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.
- Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units/mL blood checked twice at least 1 month apart
- Other uncontrolled infections
- Live vaccine given within 6 weeks of the start of the trial
- Malignancy or treated for malignancy within the past year
- Currently pregnant or breast feeding
- Life expectancy less than 1 month
- Subjects unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home
- Other conditions that the investigators feel contraindicate participation in the study
- Patients who experienced SAEs during the original trial, and such SAEs were determined as related to treatment, or patients who in the opinion of the investigator would not benefit from the extended treatment option.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Jocelyn Farmer, MD, Jocelyn.Farmer@lahey.org
Ahmed Sanousi, Ahmed.Sanousi@lahey.org
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Michael Jordan, 513-803-9063, Michael.Jordan@cchmc.org
Michael Jordan, MD
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
Katherine Prince, 919-681-8931, katherine.prince@duke.edu
Peter Bressler, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Dahir Sharif, 507-255-1574, sharif.dahir@mayo.edu
Avni Joshi, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Alma Andrade, 415-476-7054, Alma.Andrade@ucsf.edu
Michele Pham, MD
- Recruiting
University of South Florida
Tampa, Florida, 33620
Jolan Walter, 727-553-1258, jolanwalter@usf.edu
Jolan Walter, MD
About this study
There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID. This study is a multi-site, phase II, randomized, blinded/placebo-controlled clinical trial in pediatric and adult subjects to determine the efficacy of abatacept compared to placebo for treatment of subjects with GLILD in the context of CVID.
Funding Source - FDA OOPD
Read the detailed description
There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept is a recombinant, human fusion protein of cytotoxic T lymphocyte-associated protein 4 (CTLA-4) and human IgG1 that blocks T cell activation by binding to CD80 and CD86, thereby blocking CD28 engagement- the "second signal" needed for T cell activation. Abatacept has recently looked promising for the treatment of patients with complex CVID.
This study is a multi-site, phase II, randomized, blinded/placebo-controlled clinical trial in pediatric subjects ≥50 kg and adult subjects (cohort 1), with an additional cohort (#2) of pediatric subjects <50 kg tested as a single arm, receiving open-label abatacept. Cohort 1 utilizes a 'delayed-start' design to obtain maximum statistical power from this cohort. Cohort 2 will be open label due to the lack of a suitable placebo for pediatric dose abatacept syringes. A total of 21-30 evaluable subjects will be treated in cohort 1 and 8 evaluable subjects in cohort 2.
Following the initial 12 months of treatment, patients will have the option of continuing abatacept for up to 3 years. Patients will have the option of continuing abatacept any time after the initial 12 months of treatment (does not have to be immediately). A separate consent form will be utilized to document a patient's decision to continue. Abatacept will be provided by BMS. Patients who decide to continue abatacept will be monitored for safety, including infections, approximately every 3 months.
- Being tested
- Abatacept, Placebo
- Medical subject headings
- Lung Diseases, Interstitial, Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia
Abatacept is a selective costimulation modulator, inhibiting T lymphocyte activation by binding to CD80 and CD86, thereby blocking interaction with CD28. Orencia solution supplied in a prefilled syringe should be refrigerated at 2C to 8C (36F to 46F). Orencia should not be used beyond the expiration date on the prefilled syringe. The product should be protected from light by storing in the original package until time of use. The prefilled syringe should not be frozen.
PlaceboOther
The composition of the placebo for Orencia is the same as the active study drug without the abatacept. The placebo will be packaged and labeled as described above for the Orencia prefilled syringes. To maintain the blind, injection volumes will be the same as the active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | Pediatric subjects weighing <50 kg will be placed in an single arm with abatacept with dosing based on weight. Pediatric subjects weighing ≥50kg and adult subjects will enter a double blinded, randomization in a 1:2 ratio of subjects to the abatacept treatment group (arm 1) or to the placebo group (arm 2) treated weekly through month 6. After month 6, all subjects will begin receiving abatacept weekly.
Pediatric dosing:
Abatacept subcutaneous every week:
10-25 kg: 50 mg; 25-50 kg: 87.5 mg; >50 kg: 125 mg
Adult dosing:
Abatacept: 125 mg subcutaneous every week Receives: Drug: Abatacept |
| Placebo | Placebo comparator | Pediatric subjects weighing ≥50kg and adult subjects will enter a double blinded, randomization in a 1:2 ratio of subjects to the abatacept treatment group (arm 1) or to the placebo group (arm 2) treated weekly through month 6. The composition of the placebo is the same as the active study drug without the abatacept. To maintain the blind, injection volumes will be the same as the active treatment. After month 6, all subjects will begin receiving abatacept weekly. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Resolution CT Scan of the chest (HRCT)
Proportion of subjects achieving a significant response (defined as >30 percent change in lung tissue disease burden by GLILD) on HRCT after 6 months of abatacept therapy.
Measured: 6 months
Secondary outcomes (18)
Forced vital capacity (FVC)
Forced vital capacity (FVC)
Measured: 6 months, 12 months
Forced expiratory volume (FEV)
Forced expiratory volume (FEV)
Measured: 6 months, 12 months
Diffusion capacity of carbon monoxide (DLCo)
Diffusion capacity of carbon monoxide (DLCo)
Measured: 6 months, 12 months
Incidence
Incidence of new onset autoimmune/inflammatory diseases while on abatacept or placebo
Measured: 6 months, 12 months
Resolution
Resolution of existing autoimmune/inflammatory diseases while on abatacept or placebo
Measured: 6 months, 12 months
Change in Short Form-36 scores
Short Form-36: scoring ranges from 0-100 where a higher score denotes better health
Measured: 6 months, 12 months
Change in PedsQL (Pediatric Quality of Life) Generic Core scores
PedsQL Generic Core Scales: items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL. Range of 0-2300 for ages above 4, range of 0-2100 for 4 years old
Measured: 6 months, 12 months
Change in King's Interstitial Lung Disease scores
King's Interstitial Lung Disease: scoring ranges from 0-100 where a higher score denotes better health
Measured: 6 months, 12 months
Steroid usage
Cumulative number of steroids used after 6 months and 12 months
Measured: 6months, 12 months
Survival
Survival at 12 months
Measured: 6 months, 12 months
Pediatric growth - change in height
Change in height at 6 and 12 months.
Measured: 6 months, 12 months
Pediatric growth - change in weight
Change in weight at 6 and 12 months.
Measured: 6 months, 12 months
Additional Immune Agents
Rate of discontinuation of additional immune agents while on study agent
Measured: 6 months, 12 months
Adverse Events/Serious Adverse Events
Incidence of adverse events and severe adverse events, compared to placebo
Measured: 6 months, 12 months
Dropout rate
Study dropout rate
Measured: 6 months, 12 months
Incidence of concurrent infections
Incidence of concurrent infections while on study
Measured: 6 months, 12 months
Treatment of concurrent infections
Number of infections per patient which require treatment with antibiotics
Measured: 6 months, 12 months
Complications of concurrent infections
Complications of concurrent infections while on study
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start14 Jul 2021
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, blinded/placebo-controlled clinical trial in pediatric and adult subjects ≥50 kg (cohort 1), with an additional cohort (#2) of pediatric subjects \<50 kg tested as a single arm, receiving open-label abatacept
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Michael Jordan, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925375
- Sponsor's protocol ID
- 2020-0876
- Other IDs
- R01FD007267
- Acronym
- ABCVILD
- Status last verified
- Jul 2026
- First submitted
- 11 May 2021
- Last updated
- 22 Jul 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04925375
- Acronym / sponsor ID
- ABCVILD / 2020-0876
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 14 Jun 2021 (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.
There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID. This study is a multi-site, phase II, randomized, blinded/placebo-controlled clinical trial in pediatric and adult subjects to determine the efficacy of abatacept compared to placebo for treatment of subjects with GLILD in the context of CVID.
Funding Source - FDA OOPD
Detailed description
There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept is a recombinant, human fusion protein of cytotoxic T lymphocyte-associated protein 4 (CTLA-4) and human IgG1 that blocks T cell activation by binding to CD80 and CD86, thereby blocking CD28 engagement- the "second signal" needed for T cell activation. Abatacept has recently looked promising for the treatment of patients with complex CVID.
This study is a multi-site, phase II, randomized, blinded/placebo-controlled clinical trial in pediatric subjects ≥50 kg and adult subjects (cohort 1), with an additional cohort (#2) of pediatric subjects <50 kg tested as a single arm, receiving open-label abatacept. Cohort 1 utilizes a 'delayed-start' design to obtain maximum statistical power from this cohort. Cohort 2 will be open label due to the lack of a suitable placebo for pediatric dose abatacept syringes. A total of 21-30 evaluable subjects will be treated in cohort 1 and 8 evaluable subjects in cohort 2.
Following the initial 12 months of treatment, patients will have the option of continuing abatacept for up to 3 years. Patients will have the option of continuing abatacept any time after the initial 12 months of treatment (does not have to be immediately). A separate consent form will be utilized to document a patient's decision to continue. Abatacept will be provided by BMS. Patients who decide to continue abatacept will be monitored for safety, including infections, approximately every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, blinded/placebo-controlled clinical trial in pediatric and adult subjects ≥50 kg (cohort 1), with an additional cohort (#2) of pediatric subjects <50 kg tested as a single arm, receiving open-label abatacept
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Drug: AbataceptPediatric subjects weighing <50 kg will be placed in an single arm with abatacept with dosing based on weight. Pediatric subjects weighing ≥50kg and adult subjects will enter a double blinded, randomization in a 1:2 ratio of subjects to the abatacept treatment group (arm 1) or to the placebo group (arm 2) treated weekly through month 6. After month 6, all subjects will begin receiving abatacept weekly. Pediatric dosing: Abatacept subcutaneous every week: 10-25 kg: 50 mg; 25-50 kg: 87.5 mg; >50 kg: 125 mg Adult dosing: Abatacept: 125 mg subcutaneous every week |
| Placebo | Placebo comparator | Other: PlaceboPediatric subjects weighing ≥50kg and adult subjects will enter a double blinded, randomization in a 1:2 ratio of subjects to the abatacept treatment group (arm 1) or to the placebo group (arm 2) treated weekly through month 6. The composition of the placebo is the same as the active study drug without the abatacept. To maintain the blind, injection volumes will be the same as the active treatment. After month 6, all subjects will begin receiving abatacept weekly. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of CVID according to the international consensus document (ICON)
- On replacement immunoglobulin for at least 6 months and willing to maintain throughout study
- Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
- Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 3 months of study entry.
- Signed written informed consent
Key exclusion criteria (16 listed)
- History of hypersensitivity to abatacept or any of its components
- Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months
- Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as >15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months
- Have started or increased any of the following immune modulating drugs within 3 months of enrolling and 3 months from initial CT chest: azathioprine, cyclosporine, tacrolimus, mercaptopurine, methotrexate, mycophenolate mofetil, or sirolimus
- History of HIV infection (positive PCR)
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 |
|---|---|---|
| AbataceptAlso: OrenciaAbatacept is a selective costimulation modulator, inhibiting T lymphocyte activation by binding to CD80 and CD86, thereby blocking interaction with CD28. Orencia solution supplied in a prefilled syringe should be refrigerated at 2C to 8C (36F to 46F). Orencia should not be used beyond the expiration date on the prefilled syringe. The product should be protected from light by storing in the original package until time of use. The prefilled syringe should not be frozen. | Drug | Abatacept |
| PlaceboThe composition of the placebo for Orencia is the same as the active study drug without the abatacept. The placebo will be packaged and labeled as described above for the Orencia prefilled syringes. To maintain the blind, injection volumes will be the same as the active treatment. | Other | Placebo |
Primary outcome
High Resolution CT Scan of the chest (HRCT)
Time frame: 6 months
Proportion of subjects achieving a significant response (defined as >30 percent change in lung tissue disease burden by GLILD) on HRCT after 6 months of abatacept therapy.
18 secondary outcomes
Forced vital capacity (FVC)
Time frame: 6 months, 12 months
Forced expiratory volume (FEV)
Time frame: 6 months, 12 months
Diffusion capacity of carbon monoxide (DLCo)
Time frame: 6 months, 12 months
Incidence
Time frame: 6 months, 12 months
Resolution
Time frame: 6 months, 12 months
Change in Short Form-36 scores
Time frame: 6 months, 12 months
Change in PedsQL (Pediatric Quality of Life) Generic Core scores
Time frame: 6 months, 12 months
Change in King's Interstitial Lung Disease scores
Time frame: 6 months, 12 months
Steroid usage
Time frame: 6months, 12 months
Survival
Time frame: 6 months, 12 months
Pediatric growth - change in height
Time frame: 6 months, 12 months
Pediatric growth - change in weight
Time frame: 6 months, 12 months
Additional Immune Agents
Time frame: 6 months, 12 months
Adverse Events/Serious Adverse Events
Time frame: 6 months, 12 months
Dropout rate
Time frame: 6 months, 12 months
Incidence of concurrent infections
Time frame: 6 months, 12 months
Treatment of concurrent infections
Time frame: 6 months, 12 months
Complications of concurrent infections
Time frame: 6 months, 12 months
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 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Interstitial Lung Disease
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
Radiation Pneumonitis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
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.
Michael Jordan principal investigator
Children's Hospital Medical Center, Cincinnati
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept in people with Interstitial Lung Disease and Common Variable Immunodeficiency, run by Children's Hospital Medical Center, Cincinnati at 6 sites in United States.
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 16 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. 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 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?
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 Michael Jordan (513-803-9063, Michael.Jordan.@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Resolution CT Scan of the chest (HRCT) (time frame: 6 months). 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 22 Jul 2026.