A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors

August 5, 2024 updated by: Sanofi

A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With Cemiplimab in Adult Patients With Advanced Solid Tumors

Primary Objectives:

Dose escalation (Part 1)

Part 1A (SAR439459 monotherapy)

  • To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors.

Part 1B (SAR439459 and cemiplimab combination therapy)

  • To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors.

Dose expansion (Part 2)

Part 2A (SAR439459 monotherapy)

  • To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1.

Part 2B (SAR439459 and cemiplimab combination therapy)

  • To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).

Secondary Objectives:

  • Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459.
  • Immunogenicity of SAR439459 monotherapy and combined with cemiplimab.

Dose escalation (Part 1)

  • Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab.
  • Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab.

Dose expansion (Part 2)

  • Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab.
  • To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 4 weeks (28 days), a treatment period of at least 1 or 2 cycles (21 or 14 days per cycle, respectively), an end-of-treatment visit at least 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier. For the urothelial cancer cohort in Part 2B, follow-up visits will occur every 3 months until death, study cut-off date, or upon cancellation of Survival follow-up at the discretion of the Sponsor at any prior timepoint. For the overall survival analysis (approximately 12 months after last patient first dose), whichever comes first.

Patients who have no disease progression, and continue to benefit from the study drug(s), will be allowed to continue treatment beyond the common study end-date at their assigned dose unless the study is terminated by the Sponsor. The expected enrollment period is approximately 42 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg West, Victoria, Australia, 3081
        • Investigational Site Number : 0360002
      • Melbourne, Victoria, Australia, 3000
        • Investigational Site Number : 0360001
  • Belgium
      • Leuven, Belgium, 3000
        • Investigational Site Number : 0560001
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Investigational Site Number : 1240003
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Investigational Site Number : 1240001
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Investigational Site Number : 1240002
  • Estonia
      • Tallinn, Estonia, 13419
        • Investigational Site Number : 2330001
  • France
      • Marseille, France, 13385
        • Investigational Site Number : 2500002
      • Nantes, France, 44093
        • Investigational Site Number : 2500005
      • Nantes, France, 44093
        • Investigational Site Number : 2500003
      • Villejuif, France, 94800
        • Investigational Site Number : 2500001
  • Germany
      • Essen, Germany, 45122
        • Investigational Site Number : 2760001
      • Hannover, Germany, 30625
        • Investigational Site Number : 2760003
  • Italy
      • Milano, Italy, 20133
        • Investigational Site Number : 3800001
      • Milano, Italy, 20141
        • Investigational Site Number : 3800002
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Investigational Site Number : 3800003
  • Korea, Republic of
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03080
        • Investigational Site Number : 4100001
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 138-736
        • Investigational Site Number : 4100002
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Investigational Site Number : 5280001
      • Utrecht, Netherlands, 3584 CX
        • Investigational Site Number : 5280002
  • Spain
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Investigational Site Number : 7240001
      • Barcelona, Barcelona [Barcelona], Spain, 08003
        • Investigational Site Number : 7240002
    • Madrid, Comunidad De
      • Madrid / Madrid, Madrid, Comunidad De, Spain, 28050
        • Investigational Site Number : 7240004
      • Madrid / Madrid, Madrid, Comunidad De, Spain, 28040
        • Investigational Site Number : 7240003
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Investigational Site Number : 7240005
  • Taiwan
      • Tainan, Taiwan, 704
        • Investigational Site Number : 1580002
  • United Kingdom
    • Central Bedfordshire
      • Glasgow, Central Bedfordshire, United Kingdom, G12 0YN
        • Investigational Site Number : 8260001
    • Vale Of Glamorgan, The
      • Cardiff, Vale Of Glamorgan, The, United Kingdom, CF14 2TL
        • Investigational Site Number : 8260002
  • United States
    • Kansas
      • Fairway, Kansas, United States, 66205
        • The University of Kansas Clinical Research Center Site Number : 8400004
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Site Number : 8400001
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute Site Number : 8400101
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Site Number : 8400008
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC Site Number : 8400006
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research Center Site Number : 8400003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

Dose escalation (Part 1A and Part 1B)

  • Patients with histologically confirmed, advanced unresectable or metastatic solid tumor whom in the opinion of the Investigator does not have a suitable alternative therapy.

Dose expansion (Part 2A)

  • Patients with histologically confirmed, advanced unresectable or metastatic melanoma whom in the opinion of the Investigator does not have a suitable alternative therapy.
  • Patients must have failed after any prior therapy based on anti-PD-1 or anti-PD-L1 as defined by disease progression within 26 weeks of initiating anti-PD-1 or anti-PD-L1 based therapy without any evidence of a response (primary resistance to anti-PD-1 or anti-PD-L1).
  • Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy. Patients must be able and willing to provide mandatory tumor biopsies prior to and during study treatment.

Dose expansion (Part 2B)

  • Patients with disease location amenable to mandatory tumor biopsy at baseline with histologically confirmed advanced unresectable or metastatic melanoma, colorectal adenocarcinoma, urothelial cancer, hepatocellular carcinoma (HCC), or non-small cell lung cancer (NSCLC).
  • Melanoma patients must have failed one prior therapy based on anti-PD-1 or anti-PD-L1.
  • Patients with colorectal cancer must have progressed after last line of therapy.
  • Patients with urothelial cancer must have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients must not have received >2 lines of therapy for advanced disease. Patients must not have received prior treatment with anti-PD-1 or anti-PD-L1.
  • Patients with HCC must have failed after 1 prior therapy based on anti-PD-1 or anti-PD-L1.
  • Patients with NSCLC must have failed during or after 1 prior therapy based on anti-PD-1 or anti-PD-L1.
  • Patients with histologically confirmed, advanced unresectable or metastatic melanoma, or colorectal cancer or NSCLC whom in the opinion of the Investigator do not have a suitable alternative therapy.

Dose expansion parts 2A and 2B

  • At least 1 measurable lesion by RECIST v1.1.

All cohorts

  • Patient understands and has signed Informed Consent form and is willing and able to comply with the requirements of the trial.

Exclusion criteria:

  • Age <18 years or < the country's legal age of majority if the legal age is more than 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status >1.
  • Concurrent treatment with any other anticancer therapy (including radiotherapy or investigational agents) or participation in another clinical study.
  • Washout period of less than 3 weeks to prior anticancer therapy.
  • Women of reproductive potential and male subjects with female partners of childbearing potential who are not willing to avoid pregnancy by using highly effective contraceptive.
  • Pregnant or breast-feeding women.
  • Unwillingness and inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
  • Significant and uncontrolled concomitant illness, including any psychiatric condition.
  • Active infections, including unexplained fever (temperature >38.1ºC), or antibiotic therapy within 1 week prior to enrollment.
  • Any prior organ transplant including allogeneic bone marrow transplant.
  • History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
  • History of known human immunodeficiency virus (HIV), HIV serology at screening will be conducted only for patients in German study sites.
  • Known uncontrolled hepatitis B virus (HBV) infection.
  • Known untreated current hepatitis C virus (HCV) infection.
  • Any major surgery within the last 28 days.
  • Patients with primary central nervous system (CNS) tumors and/or CNS metastases of non-CNS primary tumors.
  • History of congestive heart failure, myocardial infarction with reduced ejection fraction, symptomatic coronary artery disease, documented uncontrolled hypertension, major clinically significant Electrocardiography (ECG) and echocardiogram abnormalities, significant ventricular arrhythmias, significant valvular heart disease (including valve replacement), vascular malformation, aneurysm, significant pulmonary conditions such as idiopathic pulmonary hypertension, uncontrolled chronic lung disease.
  • History of severe, acute or chronic renal diseases.
  • Any of the following within 6 months prior to study enrollment: pulmonary embolism, deep vein thrombosis, active uncontrolled bleeding, infectious or inflammatory bowel disease, diverticulitis, intestinal obstruction or perforation and gastrointestinal hemorrhage.
  • Inadequate hematological, renal or liver function.
  • Non-resolution of any prior treatment related toxicity to Grade <2.
  • Prior treatment with any anti-transforming growth factor β (anti-TGFβ) inhibitors.
  • Known allergies to any component of SAR439459 and/or cemiplimab.
  • Patients with uveal melanoma and patients with prior or ongoing uveitis.
  • Patients who received prior immunotherapy who developed toxicity leading to a permanent discontinuation of immunotherapy.
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
  • Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of SAR439459 and/or cemiplimab (occasional use of inhaled, intraocular, nasal or topical steroids for symptomatic relief allowed).
  • History of interstitial lung disease or active non-infectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
  • Patients with underlying cancer predisposition syndromes.
  • Receipt of a live vaccine within 30 days of planned start of study medication.
  • Therapeutic doses of anticoagulants or antiplatelet agents within 7 days prior the first dose of SAR439459.
  • Prothrombin time (PT) or international normalized ratio (INR) > 1.5 × upper limit of normal (ULN).
  • Patients accommodated in an institution because of regulatory or legal order; prisoners or patients who are legally institutionalized.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation SAR439459 monotherapy
SAR439459 administered intravenously every 2 weeks in a 14-day cycle with escalating doses
Biological: SAR439459

Pharmaceutical form: powder for solution for infusion

Route of administration: intravenous infusion
Experimental: Dose Expansion SAR439459 monotherapy
SAR439459 administered intravenously every 3 weeks in a 21-day cycle with the previously determined recommended doses as the patients will be randomized to 2 different doses
Biological: SAR439459

Pharmaceutical form: powder for solution for infusion

Route of administration: intravenous infusion
Experimental: Dose Escalation SAR439459 + cemiplimab combination
SAR439459 + cemiplimab combination administered intravenously every 2 weeks in a 14-day cycle or every 3 weeks in a 21-day cycle with escalating SAR439459 doses and cemiplimab
Biological: SAR439459

Pharmaceutical form: powder for solution for infusion

Route of administration: intravenous infusion

Drug: Cemiplimab REGN2810

Pharmaceutical form: solution for infusion

Route of administration: intravenous infusion
Experimental: Dose Expansion SAR439459 + cemiplimab combination
SAR439459 + cemiplimab combination administered intravenously every 3 weeks in a 21-day cycle with previously determined SAR439459 doses and cemiplimab
Biological: SAR439459

Pharmaceutical form: powder for solution for infusion

Route of administration: intravenous infusion

Drug: Cemiplimab REGN2810

Pharmaceutical form: solution for infusion

Route of administration: intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Dose Limiting Toxicities (DLTs)
Time Frame: Through the end of 1 or 2 cycles, total duration up to 6 weeks (for Part 1A each cycle is 2 weeks; for Part 1B each cycle is 2 or 3 weeks)
Incidence of DLTs at Cycle 1 and/or 2 in Parts 1A and 1B.
Through the end of 1 or 2 cycles, total duration up to 6 weeks (for Part 1A each cycle is 2 weeks; for Part 1B each cycle is 2 or 3 weeks)
Objective Response Rate (ORR) for Part 2B
Time Frame: Continuous throughout study assessment (up to approximately 1 year)
Efficacy as documented by ORR will be assessed by evaluation of antitumor response information according to RECIST 1.1 (Part 2B).
Continuous throughout study assessment (up to approximately 1 year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall safety profile
Time Frame: Continuous throughout study assessment (up to approximately 1 year)
The overall safety profile of SAR439459 administered in monotherapy (Part 1A and Part 2A) or in combination with cemiplimab (Part 1B and Part 2B).
Continuous throughout study assessment (up to approximately 1 year)
Progression free survival (PFS)
Time Frame: Continuous throughout study assessment (up to approximately 1 year)
The time from first investigational medicinal product (IMP) administration until objective tumor progression or death (Part 2A and Part 2B).
Continuous throughout study assessment (up to approximately 1 year)
Time to progression (TTP)
Time Frame: Continuous throughout study assessment (up to approximately 1 year)
The time from first IMP administration until objective tumor progression (Part 2A and 2B).
Continuous throughout study assessment (up to approximately 1 year)
Objective Response Rate (ORR) Part 2A
Time Frame: Continuous throughout study assessment (up to approximately 1 year)
Efficacy as documented by ORR will be assessed by evaluation of antitumor response information according to RECIST 1.1 (Part 2A).
Continuous throughout study assessment (up to approximately 1 year)
Duration of response Part 2B
Time Frame: Continuous throughout study assessment (up to approximately 1 year)
Time from initial response to the first documented tumor progression.
Continuous throughout study assessment (up to approximately 1 year)
Disease Control Rate Part 2B
Time Frame: Continuous throughout study assessment (up to approximately 1 year)
Sum of complete response, partial response and stable disease rates
Continuous throughout study assessment (up to approximately 1 year)
Immunogenicity evaluation
Time Frame: Up to approximately 1 year
Blood samples will be assessed for human anti-SAR439459 antibodies (all cohorts) and for human anti-cemiplimab antibodies (Parts 1B and 2B).
Up to approximately 1 year
Cmax for SAR439459 and for cemiplimab
Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22
Maximum plasma concentration observed.
Cycle 1, Day 1 to Day 15 or to Day 22
AUC for SAR439459
Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22
Area under the serum concentration versus time curve extrapolated to infinity.
Cycle 1, Day 1 to Day 15 or to Day 22
AUC0-tau for SAR439459 and for cemiplimab
Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to 14 or 21 days post-dose.
Cycle 1, Day 1 to Day 15 or to Day 22
t1/2z for SAR439459
Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22
Terminal half-life associated with the terminal slope (λz).
Cycle 1, Day 1 to Day 15 or to Day 22
CL for SAR439459
Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22
Total body clearance of a drug from plasma calculated using the following equation from AUC: CL= Dose/AUC on cycle 1.
Cycle 1, Day 1 to Day 15 or to Day 22
Vss for SAR439459
Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22
Estimate of Volume of distribution at the steady state after single intravenous dose.
Cycle 1, Day 1 to Day 15 or to Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCD14678 (Other Identifier: Sanofi Identifier)
  • 2018-001113-32 (EudraCT Number)
  • U1111-1187-5425 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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