An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma (ProvIDHe)

July 30, 2026 updated by: Servier Affaires Médicales

An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

Ivosidenib is approved in the United States and in EU for the treatment of advanced or metastatic CCA; this study is being conducted to conslidate the data related to the safety, efficacy, and impact on quality of life for patients. This is an open-label, single-arm study of ivosidenib, which means that all patients meeting eligibility criteria will receive two 250 mg ivosidenib tablets, totaling 500mg of drug, to be taken orally, once daily, for 28 consecutive days, also referred to as one cycle. Additional cycles can continue as long as clinical benefit is confirmed by an investigator, and consent is maintained. There will be a screening visit, study visit on day 1 of each cycle, withdrawal visit within 42 days of stopping treatment, and a follow-up visit every 6 months for up to 18 months after stopping treatment. This results in a minimum of 6 study visits for the completion of one 28-day cycle of ivosidenib. One additional study visit will be added on day one of each additional cycle of treatment. Study visits will include an electrocardiogram (ECG), physical exam, tumor assessment, according to local practive at a given site and blood and urine analyses. If at any point ivosidenib is made available as a medical prescription at the patient's site, patients will be withdrawn from the study treatment and patients will be followed to collect data on overall survival.

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.
299

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 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Armenia
      • Yerevan, Armenia
        • Erebouni MC
      • Yerevan, Armenia
        • National Center of Oncology of Ra M
  • Australia
      • Brisbane, Australia
        • Royal Brisbane & Women's Hospital
      • Fitzroy, Australia
        • St Vincent's Hospital
      • Subiaco, Australia
        • St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
      • Sydney, Australia
        • Kinghorn Cancer Centre
      • Woodville, Australia
        • The Queen Elizabeth Hospital
  • Austria
      • Graz, Austria
        • Medizinische Universitaet Graz
      • Linz, Austria
        • Ordensklinikum Linz GmbH
      • Salzburg, Austria
        • Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
      • Vienna, Austria
        • Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I
  • Belgium
      • Brussels, Belgium
        • Universite Libre de Bruxelles ULB -
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent UZ Gent
      • Leuven, Belgium
        • UZ Leuven
      • Woluwe-Saint-Lambert, Belgium
        • Cliniques Univ St Luc - Gastro-Enterology
  • Canada
      • Calgary, Canada
        • Tom Baker Cancer Center
      • Halifax, Canada
        • NSHA, QEII Health Sciences Centre
      • London, Canada
        • London Regional Cancer Program
      • Toronto, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Canada
        • Princess Margaret Cancer Center
  • France
      • Lyon, France
        • Hôpital privé Jean Mermoz
      • Marseille, France
        • Hôpital de la Timone
      • Montpellier, France
        • CHU Montpellier
      • Nantes, France
        • Centre Hospitalier Universitaire de Nantes CHU de Nantes
      • Paris, France
        • Institute Mutualiste Montsouris
      • Pessac, France
        • CHU Bordeaux, Hôpital Haut-Lévêque
      • Poitiers, France
        • CHU De Poitiers
  • Germany
      • Berlin, Germany
        • Charite Universittsmedizin Berlin
      • Dresden, Germany
        • Universitaetsklinikum Carl-Gustav-Carus
      • Düsseldorf, Germany, 40225
        • Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
      • Frankfurt, Germany
        • Universitaetsklinikum Frankfurt
      • Freiburg im Breisgau, Germany
        • Medizinische Fakultaet der Universitaet Freiburg
      • Hanover, Germany
        • Medizinische Hochschule Hannover
      • München, Germany
        • Klinikum der Universitaet Muenchen-Grosshadern
  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Dublin, Ireland
        • St. James Hospital
      • Dublin, Ireland
        • St. Vincent's Private Hospital
  • Italy
      • Bologna, Italy
        • Policlinico S. Orsola-Malpighi
      • Florence, Italy
        • Aou Careggi
      • Milan, Italy
        • Ospedale San Raffaele
      • Milan, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Naples, Italy
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
      • Reggio Emilia, Italy
        • IRCCS Arcispedale Santa Maria Nuova
      • Roma, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Rozzano, Italy
        • Humanitas Research Hospital
      • San Giovanni Rotondo, Italy
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
      • Turin, Italy
        • A.O.U. Città della Salute e della Scienza di Torino
      • Verona, Italy
        • AOUI Verona - Ospedale Borgo Roma
  • Japan
      • Kanagawa, Japan
        • Kanagawa Cancer Center
      • Kumamoto, Japan
        • Kumamoto University Hospital
      • Matsuyama, Japan
        • Shikoku Cancer Center
      • Osaka, Japan
        • Osaka International Cancer Institution
      • Sapporo, Japan
        • Hokkaido University Hospital
      • Tokyo, Japan
        • National Cancer Center Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC, location AMC
      • Limburg, Netherlands
        • Universiteit Maastricht UM - Maastricht University Medical Centre MUMC
  • Romania
      • Bucharest, Romania
        • Institutul Clinic Fundeni
      • Cluj-Napoca, Romania
        • Regional Institute of Gastroenterology and Hepatology
      • Craiova, Romania
        • Centrul de Oncologie Sfantu Necta
      • Otopeni, Romania
        • Radiotherapy Center Cluj
      • Ploieşti, Romania
        • Municipal Hospital Ploiesti
  • South Korea
      • Seongnam, South Korea
        • CHA Bundang Medical Center
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Yonsei University Health System
      • Seoul, South Korea
        • Seoul National University
  • Spain
      • A Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña (CHUAC)
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)
      • Córdoba, Spain
        • Hospital Universitario Reina Sofa
      • Elche, Spain
        • Hospital General de Elche
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital Universitario HM Sanchinarro
      • Pamplona, Spain
        • Hospital Universitario de Navarra
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital
  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)
      • Glasgow, United Kingdom
        • The Beatson Institute West of Scotland Cancer Research
      • London, United Kingdom
        • Imperial College London
      • London, United Kingdom
        • University College London Hospital NHS Trust
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Newcastle upon Tyne, United Kingdom
        • The Newcastle Upon Tyne Hospitals

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies
  • Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease
  • Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects
  • Female patients of childbearing potential must have a negative blood pregnancy test prior to starting treatment and must agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug
  • Male patients with a female partner with childbearing potential must also agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug

Exclusion Criteria:

  • Received a prior IDH1 inhibitor
  • Have received a transplant
  • Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
  • Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1
  • Have ongoing brain metastases requiring steroids
  • Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1
  • Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness
  • Are pregnant or breastfeeding

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: N/A
  • Interventional Model: Single Group 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: Ivosidenib
Ivosidenib 500 mg, taken orally as two 250 mg tablets once daily for an unlimited amount of continuous 28-day cycles
Drug: Ivosidenib Oral Tablet
Ivosidenib 500 mg

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
Number of Adverse Events (AEs) from Day 1 of Cycle 1 through 28 days after last study treatment
Time Frame: Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. All reported AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), using the latest version.
Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Number of Serious Adverse Events (SAEs) during the study treatment period (from Day 1 of Cycle 1 through the last study treatment intake or withdrawal of consent, whichever comes first).
Time Frame: Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment, 6 months after last study treatment, 12 months after last study treatment, 18 months after last study treatment
SAEs related to study drug will be collected irrespective of the time of onset. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment, 6 months after last study treatment, 12 months after last study treatment, 18 months after last study treatment
Number of QT prolongation events during electrocardiogram (ECG) assessed as Grade 2 or worse occurring from Day 1 of Cycle 1 through 28 days after last study treatment
Time Frame: Day 1 of cycle 1, week 2 of cycle 1, week 3 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
QT interval, using Fridericia's formula [QTcF], to average QTc interval > 480 to 500msec (Grade 2) or worse, as seen during an ECG. This is classified as an Adverse Event of Special Interest (AESI) for this study.
Day 1 of cycle 1, week 2 of cycle 1, week 3 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Change in Eastern Cooperative Oncology Group (ECOG) performance status (PS) score from baseline to worst value out of the post-baseline assessments.
Time Frame: Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
ECOG PS scoring consists of Grade 0 - 5, with 0 being the patient is fully active and 5 being the patient is dead. Descriptive statistics of ECOG PS over time will be summarized by frequency. Shift tables may be provided for ECOG PS from baseline to worst value of post-baseline assessments.
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Number of Adverse Events (AEs) leading to discontinuation or death from day 1 through 28 days after the last study treatment
Time Frame: Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Total number of AEs that result in discontinuation from treatment or death. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Total laboratory abnormalities using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 grading scale or the low/normal/high classifications based on laboratory normal ranges.
Time Frame: Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Listing of all laboratory hematology, coagulation, and chemistry data with values flagged as abnormal to show the corresponding NCI-CTCAE grades and the classifications relative to the laboratory normal ranges.
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Change from baseline to the worst on-treatment value of laboratory abnormalities.
Time Frame: Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Abnormalities will be classified by using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 grading scale or the low/normal/high classifications based on laboratory normal ranges. Shift tables using NCI-CTCAE grades to compare baseline to the worst on-treatment value will be used. For laboratory tests, including hematology, coagulation, and chemistry, where NCI-CTCAE grades are not defined, shift tables using the low/normal/high [low and high] classification to compare baseline to the worst on treatment may be generated. On-treatment is considered from Day 1 of Cycle 1 through 28 days after the last dose.
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Number of patients with vital sign values outside limits of the normal range at each time point.
Time Frame: Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Vital signs include systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Mean change from baseline values to the worst on-treatment value of patients with vital signs outside limits of the normal range
Time Frame: Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
On-treatment is considered from Day 1 of Cycle 1 through 28 days after the last dose. Vital signs include systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment

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 survival (OS)
Time Frame: through 28 days after last treatment
OS is defined as the time from date of enrollment to the date of death due to any cause. It will be assessed using the Kaplan-Meier (KM) method curves and estimates.
through 28 days after last treatment
Duration of response (DOR)
Time Frame: through 28 days after last treatment
DOR is defined as the time from the date of response to either progression or death. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
through 28 days after last treatment
Time to response (TTR)
Time Frame: through 28 days after last treatment
TTR is defined as the time from the date of enrollment to the date of response. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
through 28 days after last treatment
Proportion of days at home or hospital for all patients
Time Frame: through 28 days after last treatment
through 28 days after last treatment
Change from baseline of health economic measures, as assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5).
Time Frame: through 28 days after last treatment
Health economic measures, as assessed by the EQ-5D-5L, will be evaluated for patients with a baseline assessment and at least 1 post-baseline EQ-5D-5L assessment that generate a score. Change from baseline scores for each time point will be quantified with descriptive statistics.
through 28 days after last treatment
Progression-free survival (PFS) time beginning at enrollement
Time Frame: through 28 days after last treatment
PFS is defined as the time from the date of enrollment to the date at which the disease escalates or progresses. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
through 28 days after last treatment
Change from baseline of Quality of life scores
Time Frame: through 28 days after last study treatment
Measured by the validated European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21). EORTC QLQ-BIL21, will be evaluated for patients with a baseline assessment and at least 1 post-baseline QLQ-BIL21 assessment that generates a score. Change from baseline for each time point, will be summarized using descriptive statistics.
through 28 days after last study treatment

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.
Servier Affaires Médicales

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.
May 3, 2023

Primary Completion (Estimated)

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 1, 2027

Study Completion (Estimated)

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.
December 1, 2027

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).
May 17, 2023

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.
May 17, 2023

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.
May 25, 2023

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.
July 31, 2026

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.
July 30, 2026

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.
July 1, 2026

More Information

Terms related to this study

Keywords

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.
  • DIM-95031-002
  • 2022-501463-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

IPD Sharing Time Frame

After Marketing Authorization in EEA or US if the study is used for the approval.

IPD Sharing Access Criteria

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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