Lung TransplantPhase 2TIGER-LungNCT07538336
Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction
A Phase 2 study testing Emapalumab in people with Lung Transplant, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This study is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a sudden drop in lung function, called acute lung allograft dysfunction (ALAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Emapalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2026to 1 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients ≥10 months post-lung transplant who are enrolled in existing biorepository study (IRB #13-10738) will be approached if they have ALAD and elevated AI2 and CXCL9 levels
- Age: ≥18 years old
- Informed Consent: Ability to provide written informed consent to participate in the study.
Who cannot join
- Active Bacterial Infection: Positive bacterial cultures from bronchoalveolar lavage (BAL) samples at the time of ALAD diagnosis. Viral infections, which are typically treated in lung transplant recipients with a steroid taper and cleared by type I interferons, are not exclusion criteria per se.
- Active CMV or EBV Infection: Active reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) based on plasma PCR testing.
- Severe Comorbidities: Presence of severe conditions likely to compromise study participation or outcomes (e.g., terminal illness).
- Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding at the time of screening.
- Concurrent Immunosuppressive Therapy Trials: Use of investigational agents or therapies other than standard of care post-transplant immunosuppression.
- Allergy to Study Drug: Known hypersensitivity to emapalumab or any of its components.
- Insufficient Baseline Data: Lack of prior baseline FEV1 data for comparison.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Principal Investigator contact
United States2 sites
University of California, Los Angeles
Los Angeles, California, 90095
University of California, San Francisco
San Francisco, California, 94143
About this study
This study is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a sudden drop in lung function, called acute lung allograft dysfunction (ALAD).
ALAD is a serious condition that can happen after a lung transplant and can lead to worsening breathing and other complications. Right now, there is no approved treatment for ALAD.
The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.
Read the detailed description
You may be able to join if:
You had a lung transplant more than 10 months ago, and Your lung function has dropped by 10% or more compared to your best level in the past 6 months.
What will happen in the study?
As part of your usual care, you will have a procedure called a bronchoscopy (a test that looks inside your lungs). During this test, doctors will collect samples to check for infection and measure certain markers in your lungs and blood.
These results will help determine if you can join the study.
People with certain lung infections will not be able to participate.
Study treatment
The study has two parts:
Part 1 (finding the right dose):
Small groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs.
Part 2 (testing how well it works):
Participants will receive the selected dose of emapalumab. Doctors will:
Monitor blood and lung markers, Check for viruses, Follow your progress weekly for about 4 weeks.
Study goals:
The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.
The study will also look at:
Whether the condition gets worse or improves, How safe the treatment is, Overall outcomes after treatment.
- Conditions
- Lung Transplant
- Being tested
- Emapalumab, Placebo
- Keywords
- ALAD, Acute Lung Allograft Dysfunction, Lung Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmapalumabDrug
This is a one-time infusion
PlaceboDrug
This is a one-time infusion of inactive drug
| Study group | Role | What they receive |
|---|---|---|
| Part I (finding the right dose) | Active comparator | Small groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs. Receives: Drug: Emapalumab |
| Part 2 (testing how well it works) | Other | Participants will receive the selected dose of emapalumab or placebo. Doctors will:
Monitor blood and lung markers Check for viruses Follow your progress weekly for about 4 weeks Receives: Drug: Emapalumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from Acute Lung Allograft Dysfunction, defined by International Society for Heart and Lung Transplantation guidelines as a return to within 10% of baseline FEV1 within 90 days
Measured: 90 days
Secondary outcomes (1)
CXCL9 area under the curve (AUC), safety outcomes and retransplant-free survival will be used to measure ALAD Progression
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Sequential
- Model description
- This is a multi-center, prospective, biomarker-driven, placebo-controlled, randomized interventional study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Greenland, Dr., Principal investigator, University of California, San FranciscoJohn Belperio, Dr., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538336
- Sponsor's protocol ID
- 25-45438
- Acronym
- TIGER-Lung
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herlong HF, Maddrey WC, Walser M. The use of ornithine salts of branched-chain ketoacids in portal-systemic encephalopathy. Ann Intern Med. 1980 Oct;93(4):545-50. doi: 10.7326/0003-4819-93-4-545.
PubMed 7001971Concepcion J, Marti M, Vehar S, Corbitt K. Refractory MDA-5 dermatomyositis rapidly progressive interstitial lung disease successfully treated with emapalumab. Ann Rheum Dis. 2025 May;84(5):879-880. doi: 10.1016/j.ard.2025.01.010. Epub 2025 Jan 31. No abstract available.
PubMed 39893100Liu G, Qian S, Liu J, Ma H, Wang Q. Efficacy of emapalumab in treating 3 pediatric patients with epstein-barr virus-associated hemophagocytic lymphohistiocytosis complicated by multiple organ dysfunction. Ann Med. 2025 Dec;57(1):2569991. doi: 10.1080/07853890.2025.2569991. Epub 2025 Oct 9.
PubMed 41066671Shino MY, Todd JL, Neely ML, Kirchner J, Frankel CW, Snyder LD, Pavlisko EN, Fishbein GA, Schaenman JM, Mason K, Kesler K, Martinu T, Singer LG, Tsuang W, Budev M, Shah PD, Reynolds JM, Williams N, Robien MA, Palmer SM, Weigt SS, Belperio JA. Plasma CXCL9 and CXCL10 at allograft injury predict chronic lung allograft dysfunction. Am J Transplant. 2022 Sep;22(9):2169-2179. doi: 10.1111/ajt.17108. Epub 2022 Jun 15.
PubMed 35634722Groom JR, Luster AD. CXCR3 in T cell function. Exp Cell Res. 2011 Mar 10;317(5):620-31. doi: 10.1016/j.yexcr.2010.12.017.
PubMed 21376175Feng H, Zhang YB, Gui JF, Lemon SM, Yamane D. Interferon regulatory factor 1 (IRF1) and anti-pathogen innate immune responses. PLoS Pathog. 2021 Jan 21;17(1):e1009220. doi: 10.1371/journal.ppat.1009220. eCollection 2021 Jan.
PubMed 33476326Tellides G, Pober JS. Interferon-gamma axis in graft arteriosclerosis. Circ Res. 2007 Mar 16;100(5):622-32. doi: 10.1161/01.RES.0000258861.72279.29.
PubMed 17363708Zhang H, Zhang D, Xu Y, Zhang H, Zhang Z, Hu X. Interferon-gamma and its response are determinants of antibody-mediated rejection and clinical outcomes in patients after renal transplantation. Genes Immun. 2024 Feb;25(1):66-81. doi: 10.1038/s41435-024-00254-x. Epub 2024 Jan 22.
PubMed 38246974D'Elios MM, Josien R, Manghetti M, Amedei A, de Carli M, Cuturi MC, Blancho G, Buzelin F, del Prete G, Soulillou JP. Predominant Th1 cell infiltration in acute rejection episodes of human kidney grafts. Kidney Int. 1997 Jun;51(6):1876-84. doi: 10.1038/ki.1997.256.
PubMed 9186878Wiseman AC, Pietra BA, Kelly BP, Rayat GR, Rizeq M, Gill RG. Donor IFN-gamma receptors are critical for acute CD4(+) T cell-mediated cardiac allograft rejection. J Immunol. 2001 Nov 1;167(9):5457-63. doi: 10.4049/jimmunol.167.9.5457.
PubMed 11673565Moshkelgosha S, Duong A, Wilson G, Andrews T, Berra G, Renaud-Picard B, Liu M, Keshavjee S, MacParland S, Yeung J, Martinu T, Juvet S. Interferon-stimulated and metallothionein-expressing macrophages are associated with acute and chronic allograft dysfunction after lung transplantation. J Heart Lung Transplant. 2022 Nov;41(11):1556-1569. doi: 10.1016/j.healun.2022.05.005. Epub 2022 May 20.
PubMed 35691795Brunet-Ratnasingham E, Yellamilli S, Guo R, Mohanty RP, Duong A, Kolaitis NA, Hays SR, Shah RJ, Venado A, Maheshwari JA, Kleinhenz ME, Leard LE, McDyer J, Martinu T, Combes AJ, Calabrese DR, Singer JP, Greenland JR. Persistent and progressive acute lung allograft dysfunction is linked to cell compositional and transcriptional changes in small airways. J Heart Lung Transplant. 2025 Sep;44(9):1482-1492. doi: 10.1016/j.healun.2025.03.010. Epub 2025 Apr 28.
PubMed 40293382Calabrese DR, Ekstrand CA, Yellamilli S, Singer JP, Hays SR, Leard LE, Shah RJ, Venado A, Kolaitis NA, Perez A, Combes A, Greenland JR. Macrophage and CD8 T cell discordance are associated with acute lung allograft dysfunction progression. J Heart Lung Transplant. 2024 Jul;43(7):1074-1086. doi: 10.1016/j.healun.2024.02.007. Epub 2024 Feb 15.
PubMed 38367738
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction
- ClinicalTrials.gov ID
- NCT07538336
- Acronym / sponsor ID
- TIGER-Lung / 25-45438
- Conditions
- Lung Transplant
- Keywords
- ALAD, Acute Lung Allograft Dysfunction, Lung Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 20 Apr 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 is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a sudden drop in lung function, called acute lung allograft dysfunction (ALAD).
ALAD is a serious condition that can happen after a lung transplant and can lead to worsening breathing and other complications. Right now, there is no approved treatment for ALAD.
The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.
Detailed description
You may be able to join if:
You had a lung transplant more than 10 months ago, and Your lung function has dropped by 10% or more compared to your best level in the past 6 months.
What will happen in the study?
As part of your usual care, you will have a procedure called a bronchoscopy (a test that looks inside your lungs). During this test, doctors will collect samples to check for infection and measure certain markers in your lungs and blood.
These results will help determine if you can join the study.
People with certain lung infections will not be able to participate.
Study treatment
The study has two parts:
Part 1 (finding the right dose):
Small groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs.
Part 2 (testing how well it works):
Participants will receive the selected dose of emapalumab. Doctors will:
Monitor blood and lung markers, Check for viruses, Follow your progress weekly for about 4 weeks.
Study goals:
The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.
The study will also look at:
Whether the condition gets worse or improves, How safe the treatment is, Overall outcomes after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a multi-center, prospective, biomarker-driven, placebo-controlled, randomized interventional study.
| Arm | Type | Receives |
|---|---|---|
| Part I (finding the right dose) | Active comparator | Drug: EmapalumabSmall groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs. |
| Part 2 (testing how well it works) | Other | Drug: Emapalumab, Drug: PlaceboParticipants will receive the selected dose of emapalumab or placebo. Doctors will: Monitor blood and lung markers Check for viruses Follow your progress weekly for about 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipients ≥10 months post-lung transplant who are enrolled in existing biorepository study (IRB #13-10738) will be approached if they have ALAD and elevated AI2 and CXCL9 levels
- Age: ≥18 years old
- Informed Consent: Ability to provide written informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Active Bacterial Infection: Positive bacterial cultures from bronchoalveolar lavage (BAL) samples at the time of ALAD diagnosis. Viral infections, which are typically treated in lung transplant recipients with a steroid taper and cleared by type I interferons, are not exclusion criteria per se.
- Active CMV or EBV Infection: Active reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) based on plasma PCR testing.
- Severe Comorbidities: Presence of severe conditions likely to compromise study participation or outcomes (e.g., terminal illness).
- Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding at the time of screening.
- Concurrent Immunosuppressive Therapy Trials: Use of investigational agents or therapies other than standard of care post-transplant immunosuppression.
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 |
|---|---|---|
| EmapalumabThis is a one-time infusion | Drug | Part 2 (testing how well it works), Part I (finding the right dose) |
| PlaceboThis is a one-time infusion of inactive drug | Drug | Part 2 (testing how well it works) |
Primary outcome
Recovery from Acute Lung Allograft Dysfunction, defined by International Society for Heart and Lung Transplantation guidelines as a return to within 10% of baseline FEV1 within 90 days
Time frame: 90 days
1 secondary outcome
CXCL9 area under the curve (AUC), safety outcomes and retransplant-free survival will be used to measure ALAD Progression
Time frame: 90 days
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 20 Apr 2026.
- Background: PubMed 7001971Herlong HF, Maddrey WC, Walser M. The use of ornithine salts of branched-chain ketoacids in portal-systemic encephalopathy. Ann Intern Med. 1980 Oct;93(4):545-50. doi: 10.7326/0003-4819-93-4-545.
- Background: PubMed 39893100Concepcion J, Marti M, Vehar S, Corbitt K. Refractory MDA-5 dermatomyositis rapidly progressive interstitial lung disease successfully treated with emapalumab. Ann Rheum Dis. 2025 May;84(5):879-880. doi: 10.1016/j.ard.2025.01.010. Epub 2025 Jan 31. No abstract available.
- Background: PubMed 41066671Liu G, Qian S, Liu J, Ma H, Wang Q. Efficacy of emapalumab in treating 3 pediatric patients with epstein-barr virus-associated hemophagocytic lymphohistiocytosis complicated by multiple organ dysfunction. Ann Med. 2025 Dec;57(1):2569991. doi: 10.1080/07853890.2025.2569991. Epub 2025 Oct 9.
- Background: PubMed 35634722Shino MY, Todd JL, Neely ML, Kirchner J, Frankel CW, Snyder LD, Pavlisko EN, Fishbein GA, Schaenman JM, Mason K, Kesler K, Martinu T, Singer LG, Tsuang W, Budev M, Shah PD, Reynolds JM, Williams N, Robien MA, Palmer SM, Weigt SS, Belperio JA. Plasma CXCL9 and CXCL10 at allograft injury predict chronic lung allograft dysfunction. Am J Transplant. 2022 Sep;22(9):2169-2179. doi: 10.1111/ajt.17108. Epub 2022 Jun 15.
- Background: PubMed 21376175Groom JR, Luster AD. CXCR3 in T cell function. Exp Cell Res. 2011 Mar 10;317(5):620-31. doi: 10.1016/j.yexcr.2010.12.017.
- Background: PubMed 33476326Feng H, Zhang YB, Gui JF, Lemon SM, Yamane D. Interferon regulatory factor 1 (IRF1) and anti-pathogen innate immune responses. PLoS Pathog. 2021 Jan 21;17(1):e1009220. doi: 10.1371/journal.ppat.1009220. eCollection 2021 Jan.
- Background: PubMed 17363708Tellides G, Pober JS. Interferon-gamma axis in graft arteriosclerosis. Circ Res. 2007 Mar 16;100(5):622-32. doi: 10.1161/01.RES.0000258861.72279.29.
- Background: PubMed 38246974Zhang H, Zhang D, Xu Y, Zhang H, Zhang Z, Hu X. Interferon-gamma and its response are determinants of antibody-mediated rejection and clinical outcomes in patients after renal transplantation. Genes Immun. 2024 Feb;25(1):66-81. doi: 10.1038/s41435-024-00254-x. Epub 2024 Jan 22.
- Background: PubMed 9186878D'Elios MM, Josien R, Manghetti M, Amedei A, de Carli M, Cuturi MC, Blancho G, Buzelin F, del Prete G, Soulillou JP. Predominant Th1 cell infiltration in acute rejection episodes of human kidney grafts. Kidney Int. 1997 Jun;51(6):1876-84. doi: 10.1038/ki.1997.256.
- Background: PubMed 11673565Wiseman AC, Pietra BA, Kelly BP, Rayat GR, Rizeq M, Gill RG. Donor IFN-gamma receptors are critical for acute CD4(+) T cell-mediated cardiac allograft rejection. J Immunol. 2001 Nov 1;167(9):5457-63. doi: 10.4049/jimmunol.167.9.5457.
- Background: PubMed 35691795Moshkelgosha S, Duong A, Wilson G, Andrews T, Berra G, Renaud-Picard B, Liu M, Keshavjee S, MacParland S, Yeung J, Martinu T, Juvet S. Interferon-stimulated and metallothionein-expressing macrophages are associated with acute and chronic allograft dysfunction after lung transplantation. J Heart Lung Transplant. 2022 Nov;41(11):1556-1569. doi: 10.1016/j.healun.2022.05.005. Epub 2022 May 20.
- Background: PubMed 40293382Brunet-Ratnasingham E, Yellamilli S, Guo R, Mohanty RP, Duong A, Kolaitis NA, Hays SR, Shah RJ, Venado A, Maheshwari JA, Kleinhenz ME, Leard LE, McDyer J, Martinu T, Combes AJ, Calabrese DR, Singer JP, Greenland JR. Persistent and progressive acute lung allograft dysfunction is linked to cell compositional and transcriptional changes in small airways. J Heart Lung Transplant. 2025 Sep;44(9):1482-1492. doi: 10.1016/j.healun.2025.03.010. Epub 2025 Apr 28.
- The induction of class I and II major histocompatibility complex by allogeneic stimulation is dependent on the transcription factor interferon regulatory factor 1 (IRF-1): observations in IRF-1 knockout miceLink provided by the sponsor.
- Efficacy and Safety of the Janus Kinase 1 Inhibitor Itacitinib (ITA) in Patients with Bronchiolitis Obliterans (BOS) Syndrome Following Double Lung Transplant. The Journal of Heart and Lung TransplantationLink provided by the sponsor.
- 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.
Principal Investigator contact
John Greenland, Dr. principal investigator
University of California, San Francisco
John Belperio, Dr. principal investigator
University of California, Los Angeles
2 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 Emapalumab in people with Lung Transplant, run by University of California, San Francisco at 2 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 3 inclusion and 7 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 Legna Betancourt ((415) 476-8073, legna.betancourt@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery from Acute Lung Allograft Dysfunction, defined by International Society for Heart and Lung Transplantation guidelines as a return to within 10% of baseline FEV1 within 90 days (time frame: 90 days). 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 NCT07538336, which also lists 13 linked publications.
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 20 Apr 2026.