AzTrials
AzTrials

Immune System DisorderPhase 1/2NCT04294459

Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

A Phase 1/2 study testing Isatuximab SAR650984, Acetaminophen (paracetamol) or equivalent and Ranitidine or equivalent in people with Immune System Disorder, run by Sanofi at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Primary Objectives: Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates. Phase 2: To evaluate the efficacy of isatuximab in desensitization of participants awaiting kidney transplantation. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Immune System Disorder
What is being tested?
Isatuximab SAR650984, Acetaminophen (paracetamol) or equivalent and Ranitidine or equivalent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
6 sitesin 2 countries
Study dates
18 Jun 2020to 2 May 2022
Phase
Phase 1/2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of chronic kidney disease (CKD) and active candidate on the kidney donor waitlist at the time of screening.
  • Body mass index (BMI) </=40 kg/m^2.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent.
  • For Participants in Cohort A: active candidates on the kidney waitlist with living donor.
  • For Participants in Cohort B: active candidates on the kidney waitlist with no living donor cleared for donation.

Who cannot join

  • Significant cardiac dysfunction.
  • Known active, recurrent, or chronic infection.
  • Active lupus or uncontrolled diabetes.
  • Prior treatment with rituximab within 6 months from SAR650984 administration.
  • Inadequate organ and bone marrow function at screening.
  • Pregnant or breastfeeding women or women who intend to become pregnant during participation in the study.
Show all 9Show fewer
  • Known intolerance or hypersensitivity to any component of SAR650984 or pre-medications.
  • Participants who were not suitable for participation as judged by the Investigator.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States4 sites

  • Investigational Site Number :8400004

    Houston, Texas, 77030

  • Investigational Site Number :8400002

    New York, New York, 10016

  • Investigational Site Number :8400001

    Rochester, Minnesota, 55905

  • Investigational Site Number :8400003

    San Francisco, California, 94143

Other trials in United States

Spain2 sites

  • Investigational Site Number :7240002

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number :7240001

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907

Other trials in Spain

About this study

Official title: A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation

Primary Objectives:

  • Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates.
  • Phase 2: To evaluate the efficacy of isatuximab in desensitization of participants awaiting kidney transplantation.

Secondary Objectives:

  • Phase 2: To characterize the safety profile of isatuximab in kidney transplant candidates.
  • To characterize the pharmacokinetic (PK) profile of isatuximab in kidney transplant candidates.
  • To evaluate the immunogenicity of isatuximab.
  • To assess the overall efficacy of isatuximab in desensitization of participants awaiting kidney transplantation.
Read the detailed description

The study had a screening period of up to 28 days, a treatment period of up to 12 weeks, a site visit FUP of up to 26 weeks, and an extended follow-up (FUP) until study cut-off.

The study duration involved site visit per participant (i.e., screening, treatment, site visit FUP was approximately 42 weeks.

The study duration included extended FUP per participant was approximately 97.7 weeks (depending on when the participant was enrolled).

Being tested
Isatuximab SAR650984, Acetaminophen (paracetamol) or equivalent, Ranitidine or equivalent, Diphenhydramine or equivalent, Methylprednisolone or equivalent
Keywords
Anti-CD38 monoclonal antibody
Medical subject headings
Immune System Diseases

What participants receive

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

  • Isatuximab SAR650984Drug

    Also called Sarclisa

    Pharmaceutical form: Solution for infusion

    Route of administration: Intravenous

  • Acetaminophen (paracetamol) or equivalentDrug

    Pharmaceutical form: Tablets

    Route of administration: Oral

  • Ranitidine or equivalentDrug

    Pharmaceutical form: Solution

    Route of administration: Intravenous

  • Diphenhydramine or equivalentDrug

    Pharmaceutical form: Solution

    Route of administration: Intravenous

  • Methylprednisolone or equivalentDrug

    Pharmaceutical form: Solution

    Route of administration: Intravenous

  • Montelukast or equivalentDrug

    Pharmaceutical form: Tablets

    Route of administration: Oral

Study groups in NCT04294459
Study groupRoleWhat they receive
Cohort A: Participants with cPRA >=99.90%ExperimentalParticipants with calculated panel reactive antibodies (cPRA) >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, once weekly (QW) for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then every 2 weeks (Q2W) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events (AEs) or participant's decision to stop the treatment (maximum treatment duration: 13 weeks).
Receives: Drug: Isatuximab SAR650984; Drug: Acetaminophen (paracetamol) or equivalent; Drug: Ranitidine or equivalent; Drug: Diphenhydramine or equivalent; Drug: Methylprednisolone or equivalent; Drug: Montelukast or equivalent
Cohort B: Participants with cPRA 80.00% to 99.89%ExperimentalParticipants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks).
Receives: Drug: Isatuximab SAR650984; Drug: Acetaminophen (paracetamol) or equivalent; Drug: Ranitidine or equivalent; Drug: Diphenhydramine or equivalent; Drug: Methylprednisolone or equivalent; Drug: Montelukast or equivalent

What is being measured

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

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)

    An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study drug until study cut-off date).

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  2. Number of Participants With Hematological Abnormalities

    Abnormal hematological parameters assessed were anemia, platelet count decreased, neutrophil count decreased, lymphocyte count decreased and monocytes. The hematological abnormality grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Monocytes were assessed as per potentially clinically significant abnormality (PCSA) criteria defined as: greater than (>) 0.7*10^9/L.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  3. Number of Participants With Renal Function Abnormalities

    Abnormal renal parameters assessed were creatinine increased and estimated Glomerular Filtration Rate (eGFR). The renal function abnormality grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. eGFR was assessed as per PCSA criteria: 60 (less than equal to) <= to less than (<) 90 milliliter/minute/1.73 meter square (mL/min/1.73m^2) (Mild), 30<= to <60 mL/min/1.73m^2 (Moderate), 15<=to <30 mL/min/1.73m^2 (Severe), <15 mL/min/1.73m^2 (End Stage Renal Disease).

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  4. Number of Participants With Abnormal Electrolytes Parameters

    Abnormal electrolyte parameters assessed were hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypercalcemia, hypocalcemia, blood bicarbonate decreased, hypermagnesemia, hypomagnesemia and chloride. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Chloride was estimated as per PCSA criteria: <80 millimoles per liter (mmol/L) and >115 mmol/L.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  5. Number of Participants With Abnormal Metabolism Parameters

    Abnormal metabolism parameters assessed were hypoglycemia, hypoalbuminemia and glycated Hemoglobin (HbA1c). The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. HbA1c was estimated as per PCSA criteria: >8%.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  6. Number of Participants With Liver Function Abnormalities

    Abnormal liver function parameters assessed were Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, Alkaline phosphatase (ALP) increased, and Total bilirubin (TB) increased. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  7. Percentage of Participants With Response

    Response was defined as the percentage of participants meeting at least one of the predefined desensitization efficacy criteria as measured by single antigen bead (SAB) assay as follows: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer (>=75% reduction from Baseline) to achieve target cPRA; elimination of >=1 human leukocyte antigen (HLA) antibody (i.e., mean fluorescence intensity [MFI] reduced to <2000) as measured by a SAB assay, for antibodies with Baseline MFI >=3000.

    Measured: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

Secondary outcomes (18)

  1. Pharmacokinetics (PK) Parameters: Concentration Observed at the End of First Intravenous Infusion (Ceoi) of Isatuximab

    Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.

    Measured: At End of infusion on Cycle 1 Day 1

  2. PK Parameters: Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab

    Cmax was defined as the maximum concentration observed after the first administration calculated using the noncompartmental analysis after the intravenous infusion of isatuximab.

    Measured: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

  3. PK Parameters: Time Taken to Reach Cmax (Tmax) After the First Infusion of Isatuximab

    Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab.

    Measured: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

  4. PK Parameters: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab

    Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification calculated using non-compartmental analysis after the first infusion of isatuximab.

    Measured: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

  5. PK Parameters: Time of Clast (Tlast) After First Infusion of Isatuximab

    Tlast was defined as the time of last concentration observed above the lower limit of quantification, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab.

    Measured: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

  6. PK Parameters: Trough Plasma Concentrations (Ctrough) of Isatuximab

    Ctrough was the plasma concentration of isatuximab observed just before (pre-dose) treatment administration.

    Measured: Cycle 2 Day 1

  7. PK Parameters: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 168 Hours Over the Dosing Interval (AUC0-168 Hours) After First Infusion of Isatuximab

    AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated using trapezoidal method after first infusion of isatuximab.

    Measured: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

  8. Number of Participants With Anti-drug Antibodies (ADA) Against Isatuximab

    ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  9. Duration of Response (DOR)

    Duration of response (DOR) was defined as time (in weeks) from laboratory sample collection date used in determining a participant to be a responder (defined as participants meeting at least one of the predefined desensitization efficacy criteria: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer [>=75% reduction from Baseline] to achieve target cPRA; elimination of >=1 anti-HLA antibody i.e. MFI reduced to <2000 as measured by a SAB assay, for antibodies with Baseline MFI >=3000) up to the laboratory sample collection date when participant was confirmed as no longer meeting any response criterion (i.e., non-responder) or the date of death due to any cause, whichever occurs first. DOR was analyzed using Kaplan-Meier method.

    Measured: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

  10. Number of Participants Achieving Target cPRA

    Target calculated panel reactive antibodies (cPRA) was defined as the reduction of cPRA required to achieve at least 100% increase of likelihood of compatible donor (LCD). Number of participants who achieved target cPRA was assessed using the Organ Procurement and Transplantation Network (OPTN) calculator during the specified timepoint were reported in this outcome measure. Participants who retained their target cPRA values were censored at the date of the last available laboratory assessment achieving their target cPRA.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  11. Duration for Achieving Target cPRA

    Duration of achieving target cPRA was defined as the time (in weeks) from laboratory sample collection date of achieving target cPRA (defined as the reduction of cPRA required to achieve at least 100% increase of LCD) the first time up to the laboratory sample collection date when no longer achieving target cPRA calculated using OPTN calculator or the date of death due to any cause, whichever occurs first. The duration of achieving target cPRA was assessed using the Kaplan-Meier method.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  12. Number of Participants With Anti-Human Leukocyte Antigen (HLA)-Antibody Reduction

    Number of participants with anti-HLA-antibody (Baseline MFI >=3000) reduced to <2000 as measured using a SAB assay per central laboratory assessment was reported in this outcome measure. Participants were categorized in various categories of number of antibodies which were reduced as: none, 1-5, >5-10, >10-15, and >15. If multiple visits had the same number of total anti-HLA antibody reduction, the last visit data was summarized.

    Measured: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

  13. Time to First Transplant Offer

    Time to first transplant offer was defined as time (in days) from date of first study treatment dose up to date of first kidney transplant offer. Data on transplant status were collected and followed up until study cut-off date.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  14. Time to Transplant

    Time to transplant was defined as time (in days) from date of first study treatment dose up to date of kidney transplant. Data on transplant status were collected and followed up until study cut-off date.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  15. Number of Kidney Transplant Offers

    Number of kidney transplants offers received for each participant was reported in the outcome measure. Data on transplant offers were collected and followed up until study cut-off date.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  16. Time to First Antibody Mediated Rejection (AMR) Episode

    Time to first AMR was defined as time from date of first study treatment dose up to date of biopsy with first AMR (defined as the graft rejection due to generation of antibodies against the graft). Transplanted participants without any AMR were censored at the participant's last assessment or contact date collected in the study or at the analysis cut-off date, whichever was earlier.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  17. Percentage of Participants Who Experienced Any Antibody Mediated Rejection (AMR)

    Antibody mediated rejection was defined as the graft rejection due to generation of antibodies against the graft. The number of participants with AMR field checked as 'yes' based on the graft rejection biopsy in the electronic case report form was considered.

    Measured: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

  18. Number of Participants With Graft Survival at 6 Months Post-Transplant

    Number of participants with graft survival status as functioning at 6-months post-transplant was reported in this outcome measure.

    Measured: At 6 Months post-transplant

Timeline

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

  1. First posted4 Mar 2020
  2. Study start18 Jun 2020
  3. Primary completion2 May 2022
  4. Study completion2 May 2022

Why it stopped: Terminated due to non-safety reasons

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04294459
Sponsor's protocol ID
TED16414
Other IDs
2019-004154-28, U1111-1238-9716, 2019
Status last verified
Sep 2025
First submitted
19 Feb 2020
Last updated
17 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Torija A, Matignon M, Vincenti F, Casanova-Ferrer F, Pilon C, Tambur AR, Donadeu L, Crespo E, Kervella D, Meneghini M, Torres IB, Hafkamp F, Martinez-Lacalle A, Carrera C, Zuniga J, Brar A, Cruzado J, Gaber AO, Lee H, Montgomery RA, Stegall M, Carmagnat M, Usureau C, Moreso F, Grimbert P, Bestard O. Anti-HLA serologic response to CD38-targeting desensitization therapy is challenged by peripheral memory B cells in highly sensitized kidney transplant candidates. Am J Transplant. 2025 Jan;25(1):88-101. doi: 10.1016/j.ajt.2024.08.004. Epub 2024 Aug 10.

    PubMed 39134120

  • Mannon RB, Vincenti FG. Poised for Innovation: Considerations for End Points for New Drug Development in Kidney Transplantation. J Am Soc Nephrol. 2024 Nov 1;35(11):1603-1606. doi: 10.1681/ASN.0000000000000475. Epub 2024 Aug 5. No abstract available.

    PubMed 39102302

  • Vincenti F, Bestard O, Brar A, Cruzado JM, Seron D, Gaber AO, Ali N, Tambur AR, Lee H, Abbadessa G, Paul JA, Dudek M, Siegel RJ, Torija A, Semiond D, Lepine L, Ternes N, Montgomery RA, Stegall M. Isatuximab Monotherapy for Desensitization in Highly Sensitized Patients Awaiting Kidney Transplant. J Am Soc Nephrol. 2024 Mar 1;35(3):347-360. doi: 10.1681/ASN.0000000000000287. Epub 2023 Dec 26.

    PubMed 38147137

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Isatuximab SAR650984, Acetaminophen (paracetamol) or equivalent and Ranitidine or equivalent in people with Immune System Disorder, run by Sanofi at 6 sites in 2 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 9 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: stopped early, as of the sponsor's last update on 17 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 6 sites in United States, Spain. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 30 May 2023). 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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)). The study lists 7 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 NCT04294459, which also lists 3 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 17 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