A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma

NCT04074330 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: TAK-981-1501U1111-1236-02432020-003946-36
• Study Type: interventional
• Target: 38
• Locations: 9 countries
• Sites: 59

Brief Summary

This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma. This study has 2 parts. The main aims of the study are:

• To check for side effects from treatment with TAK-981 given with rituximab.
• To check how much TAK-981 participants can tolerate.
• To check if participants with diffuse large B-cell lymphoma or follicular lymphoma respond well to treatment. Participants will receive TAK-981 and rituximab in 21-day cycles. They will continue treatment for about 12 months unless their condition gets worse (disease progression), they cannot tolerate the treatment, or they leave the study for certain reasons.

Conditions

Lymphoma, Non-Hodgkin

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (5)

• Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)

  Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.

  From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)

• Phase 1: Number of Participants With Grade 3 or Higher TEAEs

  AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which was assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.

  From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)

• Phase 1: Duration of TEAEs

  AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled.

  From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)

• Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) Per Dose Level

  DLTs were evaluated according to NCI CTCAE, Version 5.0.

  Up to 42 months

• Phase 2: Overall Response Rate (ORR)

  ORR was defined as the percentage of participants who achieved complete response (CR) and partial response (PR), as defined by the investigator according to Lugano classification for lymphomas during the study.

  Up to 42 months

Secondary Outcomes (23)

• Cmax: Maximum Observed Plasma Concentration for TAK-981

  Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)

• Tmax: Time of First Occurrence of the Maximum Plasma Concentration (Cmax) for TAK-981

  Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)

• AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981

  Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)

• AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981

  Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)

• t1/2z: Terminal Disposition Phase Half-life for TAK-981

  Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)

Study Arms (10)

Phase 1: TAK-981 10mg QW

EXPERIMENTAL

Participants with indolent or aggressive non-Hodgkin lymphoma (NHL) received TAK-981 10 mg, infusion, intravenously (IV), once weekly (QW) on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 milligram per square meter (mg/m\^2), infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or disease progression (PD) or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Phase 1: TAK-981 40mg QW

EXPERIMENTAL

Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Phase 1: TAK-981 60mg QW

EXPERIMENTAL

Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Phase 1: TAK-981 90mg QW

EXPERIMENTAL

Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Phase 1: TAK-981 90mg BIW

EXPERIMENTAL

Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Phase 1: TAK-981 120mg QW

EXPERIMENTAL

Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Phase 1: Japan Lead-in: TAK-981 60mg QW

EXPERIMENTAL

Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Phase 1: Japan Lead-in: TAK-981 60mg BIW

EXPERIMENTAL

Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981

Phase 2 (A): TAK-981 120 mg

EXPERIMENTAL

Participants with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Phase 2 (C): TAK-981 120 mg

EXPERIMENTAL

Participants with follicular lymphoma (FL) received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.

Drug: TAK-981; Drug: Rituximab

Interventions

TAK-981 DRUG

TAK-981 intravenous infusion.

Phase 1: Japan Lead-in: TAK-981 60mg BIW; Phase 1: Japan Lead-in: TAK-981 60mg QW; Phase 1: TAK-981 10mg QW; Phase 1: TAK-981 120mg QW; Phase 1: TAK-981 40mg QW; Phase 1: TAK-981 60mg QW; Phase 1: TAK-981 90mg BIW; Phase 1: TAK-981 90mg QW; Phase 2 (A): TAK-981 120 mg; Phase 2 (C): TAK-981 120 mg

Rituximab DRUG

Rituximab intravenous infusion.

Phase 1: Japan Lead-in: TAK-981 60mg QW; Phase 1: TAK-981 10mg QW; Phase 1: TAK-981 120mg QW; Phase 1: TAK-981 40mg QW; Phase 1: TAK-981 60mg QW; Phase 1: TAK-981 90mg BIW; Phase 1: TAK-981 90mg QW; Phase 2 (A): TAK-981 120 mg; Phase 2 (C): TAK-981 120 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant Population:
• o. For Phase 1 Dose Escalation: o. aNHL including mantle cell lymphoma and DLBCL histologies such as transformed DLBCL from low-grade lymphoma (follicular or others), DLBCL associated with small-cell infiltration in bone marrow, B-cell lymphoma with intermediate features between DLBCL and Burkitt's lymphoma or with intermediate features between DLBCL and Hodgkin lymphoma, FL grade 3B, and aggressive B-cell lymphoma unclassifiable who must have previously received rituximab, cyclophosphamide, doxorubicin (hydroxydaunorubicin), vincristine, (Oncovin) and prednisone (R-CHOP) (or equivalent anti-CD20 containing therapy) and 1 additional line of therapy in the r/r setting.
• o. iNHL (including FL of grades 1-3A and marginal zone lymphoma) refractory to rituximab or to any other anti-CD20 monoclonal antibodies, who have received at least 1 prior systemic therapy for r/r iNHL.
• o. Rituximab or anti-CD20 refractoriness is defined as failure to respond to, or progression during, any previous rituximab/anti-CD20-containing regimen (monotherapy or combined with chemotherapy), or progression within 6 months of the last rituximab or anti-CD20 dose.
• Note: The minimum qualifying rituximab/anti-CD20 dose is 1 full cycle (that is, weekly\*4 doses monotherapy or 1 complete dose if combined with chemotherapy). Prior anti-CD20 antibody or cytotoxic drugs may have been administered as single agents or as components of combination therapies. Each repeated course of the same single-agent or combination is considered an independent regimen.
• o. For Phase 2, the following confirmed CD20+: o. r/r DLBCL progressed or relapsed after a prior CAR T-cells therapy that has received approval by a health authority for the treatment of DLBCL (Cohort A).
• o. r/r DLBCL that has progressed or relapsed after at least 2 but no more than 3 prior lines of systemic therapy and has not I prior cellular therapy. At least one prior line of therapy must have included a CD20-targeted therapy (Cohort B).
• o. r/r FL that has progressed or relapsed after at least 2 but no more than 3 prior lines of systemic therapy. At least 1 prior line of therapy must have included a CD20-targeted therapy (Cohort C).
• Must be considered ineligible in the opinion of the investigator, or refused autologous stem-cell transplantation (ASCT).
• Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\<=) 2.
• Adequate bone marrow function per local laboratory reference range at screening as follows:
• o Platelet count greater than or equal to (\>=) 75.0\*10\^9/L, Grade 2 thrombocytopenia (platelet count \>=50.0\*10\^9 per liter \[/L\]) is allowed if it is clearly due to marrow involvement with no evidence of myelodysplastic syndrome or hypoplastic bone marrow if found. Absolute neutrophil count (ANC) \>=1.0\*10\^9/L. Hemoglobin \>=85 gram per liter (g/L) (red blood cell \[RBC\] transfusion allowed \>=14 days before assessment).
• Adequate renal and hepatic function, per local laboratory reference range at screening as follows:
• Calculated creatinine clearance \>=30 milliliter per minute (mL/min) calculated with Cockcroft-Gault formula.
• Potassium levels \>=lower limit of normal (LLN). For potassium \>upper limit of normal (ULN) discussion with Takeda medical monitor (MM)/designee recommended.

You may not qualify if:

• Central nervous system lymphoma; active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or CT scan/magnetic resonance imaging (MRI).
• History of Grade \>=3 infusion-related reaction (IRR) that lead to permanent discontinuation of previous rituximab treatment.
• Post transplantation lymphoproliferative disease except relapsed NHL after ASCT.
• Undergone ASCT or treatment with cellular therapy including CAR T within \<=12 weeks of TAK-981 dosing.
• Prior allogeneic hematopoietic stem-cell transplantation.
• Lymphomas with leukemic expression.
• Prior anticancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 5 half-lives before TAK-981 dosing, whichever is shorter. Low dose steroids (oral prednisone or equivalent \<=20 mg per day), hormonal therapy for prostate cancer or breast cancer (in adjuvant situation), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors are allowed.
• Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
• Significant medical diseases or conditions, as assessed by the Investigators and sponsor that would substantially increase the risk-benefit ratio of participating in the study. This includes but is not limited to acute myocardial infarction or unstable angina within the last 6 months; uncontrolled diabetes mellitus; significant active bacterial, viral, or fungal infections; severely immunocompromised state; severe non-compensated hypertension and congestive heart failure New York Heart Association Class III or IV; ongoing symptomatic cardiac arrhythmias of \>Grade 2, pulmonary embolism, or symptomatic cerebrovascular events; or any other serious cardiac condition (example, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
• Known chronic hepatitis C and/or positive serology (unless due to vaccination or passive immunization due to immunoglobulin \[Ig\] therapy) for chronic hepatitis B. Known Human Immunodeficiency Virus (HIV) infection.
• Second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.
• Receipt of any live vaccine within 4 weeks of initiation of study treatment.
• Active, uncontrolled autoimmune disease requiring \>20 mg of prednisone or equivalent, cytotoxics or biologicals.
• Corticosteroid use within 1 week before the first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. Participants requiring steroids at daily doses \>20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for lymphoma control or white blood cell count lowering are not eligible.
• With baseline prolongation of the QT interval with Fridericia correction method (QTcF) (example, \>470 milliseconds (ms) for women and \>450 ms for men and a history of congenital long QT syndrome, or torsades de pointes).

Sponsors & Collaborators

• Takeda: lead

Study Sites (59)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic - Cancer Center - Rochester - PPDS

Rochester, Minnesota, 55905, United States

Location

Levine Cancer Institute - Charlotte

Chapel Hill, North Carolina, 27514, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

City of Hope - Comprehensive Cancer Center (CCC)

Portland, Oregon, 97239, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Oncology (Medical City) - USOR

Dallas, Texas, 75230, United States

Location

Texas Oncology (Tyler) - USOR

Tyler, Texas, 75702, United States

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L 4M1, Canada

Location

Sir Mortimer B Davis Jewish General Hospital

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

Institut Paoli Calmettes

Marseille, Bouches-du-Rhone, 13273, France

Location

Hopital Francois Mitterand

Dijon, Cote-d'Or, 21000, France

Location

CHU Montpellier - Hopital St Eloi

Montpellier, Herault, 34090, France

Location

Hopital Prive Sevigne

Rennes, Ille-et-Vilaine, 35000, France

Location

Hotel Dieu - Nantes

Nantes, Loire-Atlantique, 44093, France

Location

Centre Henri Becquerel

Rouen, Seine-Maritime, 76038, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Hopital Universitaire Pitie Salpetriere

Paris, 75013, France

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitatsklinikum Tubingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum rechts der Isa der Technischen Universitaet Muenchen

München, Bavaria, 81675, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, Bavaria, 97080, Germany

Location

Universitatsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitatsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Otto-von-Guericke-Universitat Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Charite - Universitatsmedizin Berlin

Berlin, 12203, Germany

Location

Azienda Ospedaliera Cardinale G Panico

Tricase, Apulia, 73039, Italy

Location

Azienda Sanitaria Locale di Ravenna

Ravenna, Emilia-Romagna, 48100, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, 00152, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Istituto Nazionale Dei Tumori

Milan, Lombardy, 20133, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, Lombardy, 20162, Italy

Location

A.O.U. Maggiore della Carita

Novara, Piedmont, 28100, Italy

Location

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Turin, Piedmont, 10126, Italy

Location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Aiti, 460-0001, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

National University Corporation Tohoku University Tohoku University Hospital

Sendai, Miyagi, 980-0872, Japan

Location

Kindai University Hospital

Osakasayama-Shi, Osaka, 589-0014, Japan

Location

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Koto-Ku, Tokyo, 135-0063, Japan

Location

Hospital Clinic de Barcelona

Barcelona, '08036, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

Complejo Asistencial Universitario de Salamanca H. Clinico

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

Location

Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Beatson West of Scotland Cancer Centre - PPDS

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

University College London

London, London, City of, NW1 2PG, United Kingdom

Location

Royal Marsden Hospital - Downs Road

London, London, City of, SW7 3RP, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

University Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

Related Publications (1)

• Nakamura A, Grossman S, Song K, Xega K, Zhang Y, Cvet D, Berger A, Shapiro G, Huszar D. The SUMOylation inhibitor subasumstat potentiates rituximab activity by IFN1-dependent macrophage and NK cell stimulation. Blood. 2022 May 5;139(18):2770-2781. doi: 10.1182/blood.2021014267.

  PMID: 35226739 DERIVED

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

TAK-981; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The study was terminated due to enrollment challenges.

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

TrialDisclosures@takeda.com

1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: October 15, 2019
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

ES (7); JP (5); CN (2); US (12); CA (2); GB (6); FR (8); DE (8); IT (9)