AzTrials
AzTrials

Graft-versus-host Disease (GVHD)Phase 3NCT03139604

GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

A Phase 3 study testing Itacitinib, Prednisone and Methylprednisolone in people with Graft-versus-host Disease (GVHD), run by Incyte Corporation at 129 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Graft-versus-host Disease (GVHD)
What is being tested?
Itacitinib, Prednisone and Methylprednisolone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
439 participants
Where
129 sitesin 19 countries
Study dates
19 Jul 2017to 13 Jul 2020
Phase
Phase 3
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

  • Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
  • Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen.
  • Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
  • Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft Gault equation.
  • Willing to avoid pregnancy or fathering children.
  • Able to give written informed consent and comply with all study visits and procedures.
  • Able to swallow and retain oral medication.

Who cannot join

  • Has received more than 1 allo-HSCT.
  • Has received more than 2 days of systemic corticosteroids for aGVHD.
  • Presence of GVHD overlap syndrome.
  • Presence of an active uncontrolled infection.
  • Known human immunodeficiency virus infection.
  • Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.
Show all 17Show fewer
  • Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
  • Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.
  • Severe organ dysfunction unrelated to underlying GVHD, including:
  • Cholestatic disorders or unresolved veno-occlusive disease of the liver.
  • Clinically significant or uncontrolled cardiac disease.
  • Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
  • Currently breast feeding.
  • Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
  • Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.
  • Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Trial locations and contacts

129 sites in 19 countries.

129 sites in 19 countries

United States49 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado - Aurora Cancer Center

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Oncology Hematology in Cincinnati

    Cincinnati, Ohio, 45236

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University (OSU)

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Florida (UF) - Division of Hematology & Oncology

    Gainesville, Florida, 32610

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Greenville Health System

    Greenville, South Carolina, 29615

  • John Theurer Cancer Center At Hackensack UMC

    Hackensack, New Jersey, 07601

  • Indiana University (IU) Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Indiana Blood and Marrow Transplant

    Indianapolis, Indiana, 46237

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of California, San Diego (UCSD) - Moores Cancer Center

    La Jolla, California, 92093-0698

  • Northwell Health

    Lake Success, New York, 11042

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Southern California

    Los Angeles, California, 90033

  • University of California, Los Angeles (UCLA) - Medical Center

    Los Angeles, California, 90095-1678

  • Methodist Healthcare Foundation

    Memphis, Tennessee, 38104

  • University of Miami - Sylvester Cancer Center

    Miami, Florida, 33136

  • Sarah Cannon Research Institute, LLC (SCRI)

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903-2681

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • Columbia University

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma - Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Advocate Lutheran General Hospital - Oncology Specialists SC

    Park Ridge, Illinois, 60028

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239-3098

  • Texas Transplant Institute

    San Antonio, Texas, 78229

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Cancer Center

    Stanford, California, 94305

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Wake Forest Baptist Medical Center - Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Italy17 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari

    Cagliari, 09126

  • Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi

    Catania, 95124

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Clinica Ematologica CTA, Ospedale "San Gerardo" di Monza

    Monza, 20900

  • Casa di Cura La Maddalena

    Palermo, 90146

  • Fondazione IRCCS Policlinco San Matteo

    Pavia, 27100

  • Presidio Ospedaliero Pescara

    Pescara, 65124

  • Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

    Reggio Calabria, 89124

  • Azienda Unità Sanitaria Locale di Reggio Emilia

    Reggio Emilia, 42123

  • University of Rome La Sapienza

    Roma, 00161

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • A.O.U. Città della Salute e della Scienza di Torino

    Torino, 10126

  • SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine

    Udine, 33100

Other trials in Italy

Spain16 sites

  • Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Barcelona, 08907

  • Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Donostia

    San Sebastián, 20014

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clinico de Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Belgium8 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • General Hospital Sint-Jan Brugge-Oostend

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent (UZG)

    Ghent, 9000

  • Jessa Ziekenhuis

    Hasselt, 3500

  • Hopital universitaire du Sart Tilman de Liege

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

France8 sites

  • CHU Amiens Picardie - Hopital Sud

    Amiens, 80054

  • CHRU de Lille-Hopital Claude Huriez

    Lille, 59037

  • Hotel Dieu Hospital - Hematologie

    Nantes, 44000

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Haut Leveque - CHU Bordeaux - Maladies du sang

    Pessac, 33604

  • Hopital de Hautepierre

    Strasbourg, 67098

  • Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol

    Toulouse, 31059

  • CHU de Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Germany7 sites

  • Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln)

    Cologne, 50924

  • University Clinic Carl Gustav Carus, Technical University Dresden

    Dresden, 1307

  • Universitatsklinikum Freiburg - Klinik fur Innere Medizin I

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Hamburg - Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Leipzig

    Leipzig, 4103

  • Universitaetsmedizin der Johannes Gutenberg

    Mainz, 55131

  • UKGM Marburg Innere Medizin: Haematologie Onkolog

    Marburg, 35043

Other trials in Germany

Israel4 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah Hebrew University Medical Center Ein Karem

    Jerusalem, 9112001

  • Chaim Sheba Medical Center

    Ramat Gan, 5262160

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

United Kingdom4 sites

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Hammersmith Hospital

    London, W12 0HS

  • Nottingham University Hospitals

    Nottingham, NG5 1PB

Other trials in United Kingdom

Portugal3 sites

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa)

    Lisbon, 1099-023

  • Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

Switzerland3 sites

  • Universtity Hospital Basel - Haematology

    Basel, 4031

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

  • Universitaetsspital Zuerich - Klinik fuer Haematology

    Zurich, CH-8091

Other trials in Switzerland

Poland2 sites

  • Centrum Onkologii- Instytut w Gliwicach

    Gliwice, 44-101

  • Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

Other trials in Poland

Australia1 site

  • St Vincents Hospital Sydney Limited

    Darlinghurst, NSW 2010

Other trials in Australia

Austria1 site

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

Other trials in Austria

Czechia1 site

  • UHKT Prague - Institute of Hematology and Blood Transfusion

    Prague, 128 20

Other trials in Czechia

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, 00290

Other trials in Finland

Greece1 site

  • General Hospital of Thessaloniki G. Papanikolaou - Hematology Department

    Chortiatis, 57010

Other trials in Greece

New Zealand1 site

  • Auckland District Health Board

    Auckland, 1023

Other trials in New Zealand

South Korea1 site

  • Seoul National University Hospital

    Seoul, 3080

Other trials in South Korea

Taiwan1 site

  • China Medical University Hospital

    Taichung, 40447 ROC

Other trials in Taiwan

About this study

Official title: GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

Being tested
Itacitinib, Placebo, Prednisone, Methylprednisolone
Keywords
Acute graft-versus-host disease, Janus kinase (JAK) inhibitor, itacitinib, corticosteroids, allogeneic hematopoietic stem cell transplant (allo-HSCT)
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItacitinibDrug

    Also called INCB039110

    Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.

  • PlaceboDrug

    Matching placebo tablets administered orally once daily (QD) plus corticosteroids.

  • PrednisoneDrug

    Also called Deltasone, Prednicot, predniSONE Intensol, Rayos

    Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.

  • MethylprednisoloneDrug

    Also called Medrol, Medrol Dosepak, Solu-Medrol

    Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.

Study groups in NCT03139604
Study groupRoleWhat they receive
ItacitinibExperimentalItacitinib plus corticosteroids
Receives: Drug: Itacitinib; Drug: Prednisone; Drug: Methylprednisolone
PlaceboPlacebo comparatorMatching placebo plus corticosteroids
Receives: Drug: Placebo; Drug: Prednisone; Drug: Methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index

    Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).

    Measured: Day 28

Secondary outcomes (19)

  1. Nonrelapse Mortality

    Defined as the percentage of participants who died due to causes other than malignancy relapse.

    Measured: Month 6,9,12 and 24

  2. Duration of Response

    Defined as the interval from first response until GVHD progression or death.

    Measured: Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months

  3. Cmax of Itacitinib When Administered in Combination With Corticosteroids

    Defined as maximum observed plasma concentration.

    Measured: Protocol-defined timepoints up to Day 28

  4. Cmin of Itacitinib When Administered in Combination With Corticosteroids

    Defined as minimum observed plasma concentration.

    Measured: Protocol-defined timepoints up to Day 28

  5. Tmax of Itacitinib When Administered in Combination With Corticosteroids

    Defined as time to maximum plasma concentration.

    Measured: Protocol-defined timepoints up to Day 28

  6. AUC of Itacitinib When Administered in Combination With Corticosteroids

    Defined as area under the concentration-time curve.

    Measured: Protocol-defined timepoints up to Day 28

  7. CL/F of Itacitinib When Administered in Combination With Corticosteroids

    Defined as oral dose clearance.

    Measured: Protocol-defined timepoints up to Day 28

  8. Time to Response

    Defined as the interval from treatment initiation to first response

    Measured: End of Study, total particpation expected to average 24 months

  9. Relapse Rate of Malignant and Nonmalignant Hematologic Disease

    Defined as the proportion of subjects whose underlying hematologic disease relapses

    Measured: Randomization through end of Study, study duration expected to average 24 months

  10. Malignancy Relapse-related Mortality Rate

    Defined as the proportion of subjects whose malignancy relapses and has a fatal outcome.

    Measured: Randomization through end of Study, study duration expected to average 24 months

  11. Failure-free Survival

    Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD)

    Measured: 6 months from randomization

  12. Overall Survival (OS)

    Defined as the interval from study enrollment to death due to any cause.

    Measured: End of Study up to approximately 24 months

  13. Number of Treatment-emergent Adverse Events With INCB39110

    Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment

    Measured: 30-35 days after end of treatment, approximately 24 months

  14. Incidence Rate of Secondary Graft Failure

    Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion

    Measured: Randomization through end of Study, study duration expected to average 24 months

  15. Proportion of Subjects Who Discontinue Corticosteroids

    Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated

    Measured: Days 28, 56, 100, and 180

  16. Proportion of Subjects Who Discontinue Immunosuppressive Medications

    Summary statistics of subjects discontinuing immunosuppressive medications will be calculated

    Measured: Days 56 and 100

  17. Incidence Rate of aGVHD Flares

    Measured: up to day 100

  18. Incidence Rate of cGVHD

    Measured: Days 180 and 365

  19. Objective Response Rate

    Measured: Days 14, 56 and 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2017
  2. Study start19 Jul 2017
  3. Primary completion2 May 2019
  4. Study completion13 Jul 2020

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03139604
Sponsor's protocol ID
INCB 39110-301
Other IDs
2017-000538-78, 2017
Status last verified
Aug 2025
First submitted
2 May 2017
Last updated
2 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.

    PubMed 35689489

  • Zeiser R, Socie G, Schroeder MA, Abhyankar S, Vaz CP, Kwon M, Clausen J, Volodin L, Giebel S, Chacon MJ, Meyers G, Ghosh M, Deeren D, Sanz J, Morariu-Zamfir R, Arbushites M, Lakshminarayanan M, Barbour AM, Chen YB. Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301): a randomised, multicentre, double-blind, phase 3 trial. Lancet Haematol. 2022 Jan;9(1):e14-e25. doi: 10.1016/S2352-3026(21)00367-7.

    PubMed 34971577

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Itacitinib, Prednisone and Methylprednisolone in people with Graft-versus-host Disease (GVHD), run by Incyte Corporation at 129 sites in 19 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 7 inclusion and 17 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 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Italy, Spain, Belgium, France and 14 more countries. 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 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?

Yes. Results are posted in the registry (first posted 15 May 2020). 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?

Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index (time frame: Day 28). 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 NCT03139604, which also lists 2 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 2 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in