Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)

NCT04029480 | Completed Phase 3 Results DMC FDA Drug

• 6 other identifiers: 8835-059PHRR190913-0021842022-501085-21-00U1111-1279-3984MK-8835-0592017-003455-35
• Study Type: interventional
• Target: 166
• Locations: 21 countries
• Sites: 102

Brief Summary

This study evaluated the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study was that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)

  Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The Bayesian mean change from baseline for each combined ertugliflozin and placebo are reported. Per protocol, the ertugliflozin arms are combined for this analysis.

  Baseline and Week 24

• Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24

  An adverse event -- Select --is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

  Up to Week 24

• Number of Participants Who Experienced an AE Up to Week 54

  An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

  Up to Week 54

• Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24

  An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

  Up to Week 24

• Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54

  An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

  Up to Week 54

Secondary Outcomes (5)

• Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo)

  Baseline and Week 24

• Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo)

  Baseline and Week 24

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

• Change From Baseline in Hemoglobin A1C at Week 54

  Baseline and Week 54

• Change From Baseline in FPG at Week 54

  Baseline and Week 54

Study Arms (4)

Ertugliflozin 5 mg

EXPERIMENTAL

All participants initially received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.

Drug: Ertugliflozin 5 mg; Drug: Placebo to ertugliflozin 15 mg; Biological: Insulin; Drug: Metformin

Ertugliflozin 5 mg/5 mg

EXPERIMENTAL

All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.

Drug: Ertugliflozin 5 mg; Drug: Placebo to ertugliflozin 15 mg; Biological: Insulin; Drug: Metformin

Ertugliflozin 5 mg/15 mg

EXPERIMENTAL

All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.

Drug: Ertugliflozin 5 mg; Drug: Ertugliflozin 15 mg; Drug: Placebo to ertugliflozin 15 mg; Drug: Placebo to ertugliflozin 5 mg; Biological: Insulin; Drug: Metformin

Placebo

PLACEBO COMPARATOR

All participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Drug: Placebo to ertugliflozin 15 mg; Drug: Placebo to ertugliflozin 5 mg; Biological: Insulin; Drug: Metformin

Interventions

Ertugliflozin 5 mg DRUG

Ertugliflozin 5 mg, oral, 1 tablet QD

Also known as: MK-8835, PF-04971729

Ertugliflozin 5 mg; Ertugliflozin 5 mg/15 mg; Ertugliflozin 5 mg/5 mg

Ertugliflozin 15 mg DRUG

Ertugliflozin 15 mg, oral, 1 tablet QD

Also known as: MK-8835, PF-04971729

Ertugliflozin 5 mg/15 mg

Placebo to ertugliflozin 15 mg DRUG

Placebo to ertugliflozin 15 mg, oral, 1 tablet QD

Ertugliflozin 5 mg; Ertugliflozin 5 mg/15 mg; Ertugliflozin 5 mg/5 mg; Placebo

Placebo to ertugliflozin 5 mg DRUG

Placebo to ertugliflozin 5 mg, oral, 1 tablet QD

Ertugliflozin 5 mg/15 mg; Placebo

Insulin BIOLOGICAL

Participants on insulin at screening continued to receive a stable dose of background insulin. The initiation and titration of insulin for rescue therapy was at the discretion of the investigator, based on local/regional/country guidelines.

Ertugliflozin 5 mg; Ertugliflozin 5 mg/15 mg; Ertugliflozin 5 mg/5 mg; Placebo

Metformin DRUG

Participants received stable dose of background metformin.

Ertugliflozin 5 mg; Ertugliflozin 5 mg/15 mg; Ertugliflozin 5 mg/5 mg; Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be ≥10 years and ≤17 years of age, when the informed consent is signed
• Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
• Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
• T2DM for ≥2 years, OR T2DM for \<2 years and a fasting C-peptide value \>0.6 ng/mL at Screening.
• On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.
• Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.

You may not qualify if:

• Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
• Has known monogenic diabetes, or secondary diabetes.
• Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
• Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
• Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication.
• Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
• Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
• Has a history of severe hypoglycemia while on insulin.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Pfizer: collaborator

Study Sites (104)

The University of Alabama at Birmingham ( Site 2207)

Birmingham, Alabama, 35233-1711, United States

Location

Children's Hospital - Los Angeles ( Site 2201)

Los Angeles, California, 90027, United States

Location

Center of Excellence in Diabetes and Endocrinology ( Site 2203)

Sacramento, California, 95821, United States

Location

Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si

Hollywood, Florida, 33021, United States

Location

ICCT Research International, Inc. ( Site 2211)

Chicago, Illinois, 60659, United States

Location

Barry J. Reiner MD LLC ( Site 2204)

Baltimore, Maryland, 21229, United States

Location

William Beaumont Hospital ( Site 2219)

Royal Oak, Michigan, 48073, United States

Location

CHEAR Center LLC ( Site 2200)

The Bronx, New York, 10455, United States

Location

Coastal Children''s Services ( Site 2202)

Wilmington, North Carolina, 28403, United States

Location

The Children's Hospital of Philadelphia ( Site 2205)

Philadelphia, Pennsylvania, 19104, United States

Location

Southern Endocrinology and Associates PA ( Site 2218)

Mesquite, Texas, 75149, United States

Location

Cliniques Universitaires Saint-Luc ( Site 2300)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

London Health Sciences Centre ( Site 0002)

London, Ontario, N6A 5W9, Canada

Location

Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)

Montreal, Quebec, H1T 2M4, Canada

Location

Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)

Barranquilla, Atlántico, 080020, Colombia

Location

MedPlus Medicina Prepagada S.A. ( Site 0102)

Bogotá, Bogota D.C., 110221, Colombia

Location

Clinica Los Yoses ( Site 0200)

San José, 11501, Costa Rica

Location

Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)

Santo Domingo, Nacional, 10101, Dominican Republic

Location

CHU du BOCAGE ( Site 0407)

Dijon, Cote-d Or, 21079, France

Location

CHU Amiens Hopital Sud ( Site 0413)

Amiens, Picardie, 80054, France

Location

Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)

Chiquimula, 20001, Guatemala

Location

Endopedia ( Site 0503)

Guatemala City, 01009, Guatemala

Location

Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502)

Guatemala City, 01014, Guatemala

Location

Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)

Pécs, Baranya, 7623, Hungary

Location

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)

Békéscsaba, Bekescsaba, 5600, Hungary

Location

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)

Székesfehérvár, Fejér, 8000, Hungary

Location

Petz Aladar Megyei Oktato Korhaz ( Site 0709)

Győr, Győr-Moson-Sopron, 9023, Hungary

Location

Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704)

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)

Budapest, 1089, Hungary

Location

Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)

Budapest, 1094, Hungary

Location

Soroka University Medical Center ( Site 0802)

Beersheba, 8410101, Israel

Location

Armon M.C ( Site 0803)

Haifa, 3350121, Israel

Location

Rambam Medical Center ( Site 0801)

Haifa, 3525408, Israel

Location

Hadassah Mount Scopus ( Site 0800)

Jerusalem, 9124001, Israel

Location

The Edmond and Lily Safra Children s Hospital ( Site 0804)

Ramat Gan, 5265601, Israel

Location

A.O.Universitaria Meyer ( Site 0901)

Florence, Tuscany, 50139, Italy

Location

U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904)

Caltanissetta, 93100, Italy

Location

IRCCS G. Gaslini ( Site 0900)

Genova, 16147, Italy

Location

AOU Federico II di Napoli ( Site 0902)

Napoli, 80123, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)

Roma, 00165, Italy

Location

Ospedale Regina Margherita ( Site 0905)

Torino, 10126, Italy

Location

Hospital Universiti Sains Malaysia ( Site 1102)

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Hospital Taiping ( Site 1104)

Taiping, Perak, 34000, Malaysia

Location

Hospital Pulau Pinang. ( Site 1101)

George Town, Pulau Pinang, 10990, Malaysia

Location

Hospital Putrajaya ( Site 1103)

Putrajaya, Putrajaya, 62000, Malaysia

Location

University Malaya Medical Centre ( Site 1100)

Kuala Lumpur, 59100, Malaysia

Location

Life Nova+ ( Site 1203)

Forbach, Pamplemousses District, 21014, Mauritius

Location

Wellkin Hospital ( Site 1200)

Moka, 80812, Mauritius

Location

Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)

Guadalajara, Jalisco, 44150, Mexico

Location

Centro de Investigacion Medica de Occidente S.C. ( Site 1001)

Guadalajara, Jalisco, 44260, Mexico

Location

CAIMED Investigación en Salud S.A de C.V ( Site 1008)

Mexico City, Mexico City, 06760, Mexico

Location

Bio Investigación AMARC, S.C. ( Site 1006)

Mexico City, Mexico City, 11410, Mexico

Location

Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)

Monterrey, Nuevo León, 64460, Mexico

Location

Unidad de Medicina Especializada SMA ( Site 1004)

San Juan del Río, Querétaro, 76800, Mexico

Location

Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)

Culiacán, Sinaloa, 80000, Mexico

Location

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)

Madero, Tamaulipas, 89440, Mexico

Location

Centro de Investigacion Medica Aguascalientes ( Site 1000)

Aguascalientes, 20116, Mexico

Location

Centro de Atencion e Investigacion Clinica SC ( Site 1009)

Aguascalientes, 20119, Mexico

Location

Davao Doctors Hospital ( Site 1400)

Davao City, Davao Del Sur, 8000, Philippines

Location

Institute for Studies on Diabetes Foundation Inc. ( Site 1402)

Marikina City, National Capital Region, 1810, Philippines

Location

West Visayas State University Medical Center ( Site 1401)

Iloilo City, 5000, Philippines

Location

IN VIVO ( Site 1501)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-046, Poland

Location

Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)

Wierzchosławice, Lesser Poland Voivodeship, 33-122, Poland

Location

Instytut Diabetologii Sp z o o ( Site 1512)

Warsaw, Masovian Voivodeship, 02-117, Poland

Location

Clinical Medical Research Sp. z o.o. ( Site 1511)

Katowice, Silesian Voivodeship, 40-156, Poland

Location

Bashkir State Medical University Hospital ( Site 1603)

Ufa, Baskortostan, Respublika, 450083, Russia

Location

Federal State Budget Institution Endocrinological Research Center ( Site 1611)

Moscow, Moscow, 117036, Russia

Location

Children's City Clinical Hospital #1 ( Site 1604)

Novosibirsk, Novosibirsk Oblast, 630048, Russia

Location

Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)

Rostov-on-Don, Rostov Oblast, 344012, Russia

Location

Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)

Samara, Samara Oblast, 443079, Russia

Location

St.Petersburg State Pediatric Medical University ( Site 1600)

Saint Petersburg, Sankt-Peterburg, 194100, Russia

Location

Kazan State Medical University ( Site 1601)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

Siberian State Medical University ( Site 1602)

Tomsk, Tomsk Oblast, 634050, Russia

Location

Voronezh State Medical University named after N.N.Burdenko ( Site 1608)

Voronezh, Voronezskaja Oblast, 394024, Russia

Location

Hera General Hospital ( Site 1725)

Mecca, Al Bahah Region, 24211, Saudi Arabia

Location

King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)

Jeddah, Makkah Al Mukarramah, 21423, Saudi Arabia

Location

King Abdulaziz Medical City - Al Ahsa ( Site 1730)

Al Ahsa, Riyadh Region, 31982, Saudi Arabia

Location

King Abdul Aziz Medical City - AlRiyadh ( Site 1700)

Riyadh, Riyadh Region, 11426, Saudi Arabia

Location

King Abdul Aziz Medical City - AlRiyadh ( Site 1705)

Riyadh, Riyadh Region, 11426, Saudi Arabia

Location

King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)

Riyadh, Riyadh Region, 11564, Saudi Arabia

Location

King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)

Riyadh, Riyadh Region, 11564, Saudi Arabia

Location

I. U. Cerrahpasa Tip Fakultesi ( Site 2406)

Istanbul, Istanbul, 34098, Turkey (Türkiye)

Location

Cukurova Uni. Tip Fakultesi ( Site 2403)

Adana, 01330, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407)

Ankara, 06800, Turkey (Türkiye)

Location

Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)

Istanbul, 34854, Turkey (Türkiye)

Location

Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (

Chernivtsi, Chernivetska Oblast, 58002, Ukraine

Location

SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)

Dnipro, Dnipropetrovsk Oblast, 49100, Ukraine

Location

MHI Regional Childrens Clinical Hospital ( Site 1908)

Kharkiv, Kharkivs’ka Oblast’, 61093, Ukraine

Location

Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)

Kharkiv, Kharkivs’ka Oblast’, 61153, Ukraine

Location

Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)

Kyiv, Kyivska Oblast, 01021, Ukraine

Location

Medical Center Verum ( Site 1913)

Kyiv, Kyivska Oblast, 03039, Ukraine

Location

Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)

Kyiv, Kyivska Oblast, 04114, Ukraine

Location

Odessa Regional Children Clinical Hospital ( Site 1912)

Odesa, Odesa Oblast, 65031, Ukraine

Location

Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)

Vinnytsia, Vinnytsia Oblast, 21010, Ukraine

Location

Dubai Diabetes Center ( Site 2002)

Dubai, Dubayy, 215252, United Arab Emirates

Location

Mustafa Al Qaysi Medical Centre ( Site 2010)

Dubai, Dubayy, 445498, United Arab Emirates

Location

Mediclinic City Hospital ( Site 2005)

Dubai, Dubayy, 505004, United Arab Emirates

Location

Al Jalila Children s Specialty Hospital ( Site 2004)

Dubai, Dubayy, 7662, United Arab Emirates

Location

Thumbay University Hospital ( Site 2001)

Ajman, 4184, United Arab Emirates

Location

Rashid Center For Diabetes and Research ( Site 2006)

Ajman, 5166, United Arab Emirates

Location

Royal London Hospital (Whitechapel) ( Site 2100)

London, London, City of, E1 1FR, United Kingdom

Location

Chelsea and Westminster Hospital ( Site 2103)

London, London, City of, SW10 9NH, United Kingdom

Location

West Middlesex University Hospital ( Site 2104)

London, London, City of, TW7 6AF, United Kingdom

Location

Related Links

• Plain Language Summary
• Merck Clinical Trials Information

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ertugliflozin; Insulin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Clinical Trials Disclosure
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 23, 2019
• Study Start: October 8, 2019
• Primary Completion: April 11, 2025
• Study Completion: April 11, 2025
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

PL (4); BE (1); FR (2); IL (5); IT (6); MY (5); SA (7); TU (4); US (11); PH (3); MA (2); CO (1); RU (9); UA (9); AE (6); DO (1); GU (3); GB (3); CA (2); ME (10); HU (8)