An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK Inhibitor Therapy and Who Require Red Blood Cell Transfusions

Sponsors

Lead Sponsor: Celgene

Source Celgene
Brief Summary

The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period.

Detailed Description

Permitted Concomitant Medications and Procedures - Subjects are receiving a JAK2 inhibitor for the treatment of MPN-associated MF that is approved in the country where the study is being conducted. JAK2 inhibitors are to be used according to their respective label and as prescribed as part of the subject's standard-of-care therapy as prescribed by their physician prior to study entry. - Best supportive care (BSC) includes, but is not limited to, treatment with transfusions (eg, RBC, platelet, whole blood), ICTs, antibiotic, antiviral and/or antifungal therapy, and nutritional support as needed. - Granulocyte colony-stimulating factors (ie, G-CSF, granulocyte macrophage colony-stimulating factor [GM-CSF]) are allowed only in cases of neutropenic fever or as clinically indicated per product label. - Prophylactic antithrombotic therapy is permitted. - Thrombopoietin and platelet transfusions are permitted. - Treatment with systemic corticosteroids is permitted for nonhematological conditions providing the subject is receiving a constant dose equivalent to ≤ 10 mg prednisone during the study. - Administration of attenuated vaccines (eg, influenza vaccine) is allowed if clinically indicated per Investigator discretion. - Iron chelation therapy (ICT) is to be used according to the product label. If the label permits, the ICT dose should be stable during at least the first 24 weeks of IP. Initiation of ICT while within the first 24 weeks of IP should be clinically indicated to treat an AE. Prohibited Concomitant Medications The following concomitant medications are specifically excluded during the course of the study: - Cytotoxic, chemotherapeutic, targeted, or investigational agents/therapies (excluding JAK2 inhibitor therapy) - Azacitidine, decitabine, or other hypomethylating agents - Lenalidomide, thalidomide, and pomalidomide - Erythropoietin stimulating agents (ESAs) and other RBC hematopoietic growth factors (eg, IL-3) - Hydroxyurea or other alkylating agents - Androgens (unless given to treat hypogonadism) - Oral retinoids (topical retinoids are permitted) - Arsenic trioxide - Interferon - Anagrelide - Systemic corticosteroids at a dose equivalent to > 10 mg prednisone - Investigational products for the treatment of MPN-associated MF

Overall Status Recruiting
Start Date 2021-02-25
Completion Date 2025-02-11
Primary Completion Date 2025-01-09
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Red blood cell-transfusion independence (RBC-TI) ≥ 12 weeks (RBC-TI 12) Up to 24 weeks
Secondary Outcome
Measure Time Frame
Red blood cell-transfusion independence ≥ 16 weeks (RBC-TI 16) Up to 24 weeks
Duration of Red blood cell-transfusion independence (RBC-TI 12) Up to end of treatment, approximately 3 years
Reduction of transfusion burden by ≥ 50% and by ≥ 4 units/12 weeks from baseline over any consecutive 12-week period Up to 24 weeks
Duration of reduction in transfusion burden Up to end of treatment, approximately 3 years
Red blood cell-transfusion independence ≥ 12 weeks in the treatment period (RBC-TI 12/TP) Up to end of treatment, approximately 3 years
Red blood cell-transfusion independence ≥ 16 weeks in the treatment period (RBC-TI 16/TP) Up to end of treatment, approximately 3 years
Change in RBC transfusion burden Up to 24 weeks
Cumulative duration of RBC-transfusion independence Up to end of treatment, approximately 3 years
Mean Hgb increase ≥ 1 g/dL from baseline over any consecutive 12-week period in absence of RBC transfusions Up to end of treatment, approximately 3 years
Change in serum ferritin from baseline Up to end of treatment, approximately 3 years
Incidence of Adverse Events (AEs) From screening up to 42 days post last dose
Transformation to blast phase: Number of subjects who transform into AML Up to approximately 5 years
Frequency of Antidrug antibodies (ADA) From randomization and up to including 48 weeks post first dose
Pharmacokinetics - Area Under the Concentration-Time Curve (AUC) From randomization and up to including 48 weeks post first dose
Pharmacokinetics - Maximum plasma concentration of drug (Cmax) From randomization and up to including 48 weeks post first dose
Enrollment 309
Condition
Intervention

Intervention Type: Drug

Intervention Name: ACE-536

Description: Subcutaneous Injection

Arm Group Label: Experimental Arm: Luspatercept (ACE-536)

Other Name: Luspatercept

Intervention Type: Other

Intervention Name: Placebo

Description: Subcutaneous Injection

Arm Group Label: Control Arm: Placebo

Eligibility

Criteria:

Inclusion Criteria: Subjects must satisfy the following criteria to be randomized in the study: 1. Subject is ≥18 years of age at the time of signing the ICF. 2. Subject has a diagnosis of PMF according to the 2016 World Health Organization (WHO) criteria or diagnosis of post-ET or post-PV MF according to the IWG-MRT 2007 criteria , confirmed by the most recent local pathology report. 3. Subject is requiring RBC transfusions as defined as: a. Average RBC-transfusion frequency: 4 to 12 RBC units/12 weeks immediately up to randomization. There must be no interval > 6 weeks (42 days) without ≥ 1 RBC transfusion. b. RBC transfusions are scored in determining eligibility when given for treatment of: - Symptomatic (ie, fatigue or shortness of breath) anemia with a pretransfusion Hgb ≤ 9.5 g/dL or - Asymptomatic anemia with a pretransfusion Hgb ≤ 7 g/dL c. RBC transfusions given for worsening of anemia due to bleeding or infections are not scored in determining eligibility. 4. Subjects on continuous (eg, absent of dose interruptions lasting ≥ 2 consecutive weeks) JAK2 inhibitor therapy as approved in the country of the study site for the treatment for MPN-associated MF as part of their standard-of-care therapy for at least 32 weeks, on stable daily dose for at least 16 weeks immediately up to the date of randomization and anticipated to be on a stable daily dose of that JAK2 inhibitor for at least 24 weeks after randomization. 5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2. 6. A female of childbearing potential (FCBP) for this study is defined as a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (eg, has had menses at any time in the preceding 24 consecutive months). Females of childbearing potential (FCBP)participating in the study must: a. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the study, and after end of IP. This applies even if the subject practices true abstinence* from heterosexual contact. b. Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception** without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 12 weeks (approximately 5 times the mean terminal half-life of IP based on multiple-dose PK data) after discontinuation of study therapy. 7. Male subjects must: Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential** while participating in the study, during dose interruptions and for at least 12 weeks (approximately 5 times the mean terminal half-life of IP based on multiple-dose PK data) following IP discontinuation, even if he has undergone a successful vasectomy. * True abstinence is acceptable when it is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.] ** Agreement to use highly effective methods of contraception that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly throughout the course of the study. Such methods include: Combined (estrogen and progestogen containing) hormonal contraception: Oral, Intravaginal, Transdermal; Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral, Injectable hormonal contraception, Implantable hormonal contraception; Placement of an intrauterine device (IUD); Placement of an intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomized partner; Sexual Abstinence. 8. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 9. Subject is willing and able to adhere to the study visit schedule and other protocol requirements including the use of the electronic patient reported outcomes device. Exclusion Criteria: The presence of any of the following will exclude a subject from randomization: 1. Subject with anemia from cause other than MPN-associated MForJAK2 inhibitor therapy (eg, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infection, or any type of known clinically significant bleeding or sequestration). 2. Subject use of hydroxyurea, immunomodulatory compounds such as pomalidomide, thalidomide, ESAs, androgenic steroids or other drugs with potential effects on hematopoiesis ≤ 8 weeks immediately up to the date of randomization. 1. Systemic corticosteroids are permitted for nonhematological conditions providing the subject is receiving a constant dose equivalent to ≤ 10 mg prednisone for the 4 weeks immediately up to randomization. 2. Iron chelation therapy (ICT) is permitted providing the subject is receiving a stable dose for the 8 weeks immediately up to randomization. 3. Subject with any of the following laboratory abnormalities at screening: 1. Neutrophils: < 1 x 109/L 2. White blood count (WBC): > 100 x 109/L 3. Platelets: the lowest allowable level as approved for the concomitant JAK2 inhibitor but not < 25 x 109/L or > 1000 x 109/L 4. Peripheral blood myeloblasts:> 5% 5. Estimated glomerular filtration rate:< 40 mL/min/1.73 m2 (via the 4-variable modification of diet in renal disease [MDRD] formula) or nephrotic subjects (eg, urine albumin-to-creatinine ratio > 3500 mg/g) 6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT):> 3.0 x upper limit of normal (ULN) 7. Direct bilirubin: ≥ 2 x ULN - Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (eg, ineffective erythropoiesis) 4. Subject with uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, that is not resolved at the time of randomization. 5. Subject with prior history of malignancies, other than disease under study, unless the subject has been free of the disease for ≥ 3 years. However, subject with the following history/concurrent conditions is allowed: 1. Basal or squamous cell carcinoma of the skin 2. Carcinoma in situ of the cervix 3. Carcinoma in situ of the breast 4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system) 6. Subject with prior hematopoietic cell transplant or subject anticipated to receive a hematopoietic cell transplant during the 24 weeks from the date of randomization. 7. Subject with stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months immediately up to the date of randomization. 8. Subject with major surgery within 2 months up to the date of randomization. Subject must have completely recovered from any previous surgery immediately up to the date of randomization. 9. Subject with a major bleeding event (defined as symptomatic bleeding in a critical area or organ and/or bleeding causing a decrease in Hgb of ≥ 2 g/dL or leading to transfusion of ≥ 2 units of packed red cells) in the last 6 months prior to the date of randomization. 10.Subject with inadequately controlled heart disease and/or have a known left ventricular ejection fraction < 35%. 11.Subject with uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment). 12.Subject with known human immunodeficiency virus (HIV), evidence of active Hepatitis B (HepB) as demonstrated by the presence of Hepatitis B surface antigen (HBsAg) and/or positive for Hepatitis B virus DNA (HBVDNA-positive), and/or evidence of active Hepatitis C (HepC) as demonstrated by a positive Hepatitis C virus RNA (HCV-RNA) test of sufficient sensitivity. 13.Subject with prior therapy of luspatercept or sotatercept. 14.Subject with history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product. 15.Pregnant or breastfeeding females. 16.Subject participation in any other clinical protocol or investigational trial that involves use of experimental therapy (including investigational agents) and/or therapeutic devices within 30 days or for investigational agents within five half-lives, whichever comes later, immediately up to the date of randomization. 17.Subject with any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study or places the subject at unacceptable risk if he/she were to participate in the study. 18.Subject with any condition or concomitant medication that confounds the ability to interpret data from the study.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Torsten Gerike, MD Study Director Bristol-Myers Squibb
Overall Contact

Last Name: Associate Director Clinical Trial Disclosure

Phone: 1-888-260-1599

Email: [email protected]

Location
Facility: Status:
University of Alabama at Birmingham | Birmingham, Alabama, 35924, United States Not yet recruiting
University of California San Diego | La Jolla, California, 92037, United States Not yet recruiting
University of California Los Angeles | Los Angeles, California, 90095, United States Not yet recruiting
University of Colorado | Aurora, Colorado, 80045, United States Not yet recruiting
Yale University School of Medicine | New Haven, Connecticut, 06520, United States Not yet recruiting
Northwestern University | Chicago, Illinois, 60611, United States Not yet recruiting
Rush University Medical Center | Chicago, Illinois, 60612, United States Recruiting
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109, United States Recruiting
Washington University | Saint Louis, Missouri, 63110, United States Recruiting
John Theurer Cancer Center | Hackensack, New Jersey, 07601, United States Not yet recruiting
Memorial Sloan Kettering Cancer Center | New York, New York, 10021-6094, United States Not yet recruiting
Mount Sinai Medical Center | New York, New York, 10029, United States Not yet recruiting
Weill Cornell Medical College - New York Presbyterian Hospital | New York, New York, 10065, United States Not yet recruiting
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States Not yet recruiting
Oregon Health & Science University | Portland, Oregon, 97239, United States Not yet recruiting
The University of Texas - MD Anderson Cancer Center | Houston, Texas, 77030, United States Not yet recruiting
CTRC at The UT Health Science Center at San Antonio | San Antonio, Texas, 78229, United States Not yet recruiting
University of Utah - Huntsman Cancer Institute | Salt Lake City, Utah, 84112, United States Not yet recruiting
Fred Hutchinson Cancer Research Center | Seattle, Washington, 98109-4417, United States Not yet recruiting
Monash Medical Centre | Clayton, Victoria, 3168, Australia Recruiting
The Alfred Hospital | Melbourne, Victoria, 3004, Australia Recruiting
Gosford Hospital | Gosford, 2250, Australia Recruiting
Royal Hobart Hospital | Hobart, 7000, Australia Recruiting
Medizinische Universitat Graz | Graz, 8036, Austria Recruiting
Krankenhaus der Elisabethinen Linz, I Interne Abteilung | Linz, 4020, Austria Recruiting
Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie | Vienna, 1090, Austria Recruiting
Hanusch Krankenhaus | Wien, 1140, Austria Recruiting
AZ Sint-Jan AV Brugge | Brugge, 8000, Belgium Not yet recruiting
Cliniques Universitaires Saint-Luc | Brussels, 1200, Belgium Not yet recruiting
Virga Jesse Ziekenhuis | Hasselt, 3500, Belgium Not yet recruiting
UZ Leuven | Leuven, 3000, Belgium Not yet recruiting
AZ Delta | Roeselare, 8800, Belgium Not yet recruiting
Centre Hospitalier Peltzer - La Tourelle | Verviers, 4800, Belgium Recruiting
Cliniques Universitaires UCL de Mont-Godine | Yvoir, 5530, Belgium Recruiting
Tom Baker Cancer Centre | Calgary, Alberta, T2N 4N2, Canada Recruiting
University of Alberta Hospital | Edmonton, Alberta, T6G 2S2, Canada Not yet recruiting
St. Paul's Hospital | Vancouver, British Columbia, V6Z 2A5, Canada Not yet recruiting
Saint John Regional Hospital | Saint John, New Brunswick, E2L 4L2, Canada Not yet recruiting
London Health Sciences Centre | London, Ontario, N6C 6B5, Canada Recruiting
Princess Margaret Cancer Centre | Toronto, Ontario, M5G 2M9, Canada Not yet recruiting
Hopital Maisonneuve-Rosemont | Montreal, Quebec, H1T 2M4, Canada Not yet recruiting
Sir Mortimer B. Davis - Jewish Genl | Montreal, Quebec, H3T 1E2, Canada Not yet recruiting
Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont | Sherbrooke, Quebec, J1H5N4, Canada Not yet recruiting
Peking Union Medical College Hospital | Beijing, 100730, China Not yet recruiting
First Hospital of Jilin University | Changchun, 130021, China Not yet recruiting
Guangdong General Hospital | Guangzhou, 510030, China Not yet recruiting
Nanfang Hospital of Southern Medical University | Guangzhou, 510515, China Not yet recruiting
The First Affiliated Hospital of Harbin Medical University | Harbin, 150081, China Not yet recruiting
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University | Nanjing, 210029, China Not yet recruiting
Ruijin Hospital Shanghai Jiaotong University | Shanghai, 200025, China Not yet recruiting
Shanghai 6th Hospital | Shanghai, 200233, China Not yet recruiting
The First Affiliated Hospital of Soochow University | Suzhou, 215006, China Not yet recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin, 300041, China Not yet recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan, 430030, China Not yet recruiting
Henan Cancer Hospital | Zhengzhou, China Not yet recruiting
Vseobecna Fakultni Nemocnice v Praze | Prague 2, 128 08, Czechia Not yet recruiting
CHRU Hopital du Bocage | Angers, 49033, France Recruiting
Hopital Henri Mondor | Creteil, 94010, France Recruiting
CHU de Grenoble | Grenoble, 38043, France Recruiting
CHRU de Lille-Hopital Claude Huriez | Lille, 59037, France Not yet recruiting
Centre Leon Berard | Lyon, 69008, France Not yet recruiting
CHU de Nice Archet I | Nice, 06202, France Not yet recruiting
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau | Nimes Cedex 9, 30029, France Recruiting
Hopital Saint Louis | Paris Cedex 10, 75475, France Recruiting
Groupe Hospitalier Sud Hopital Haut Leveque USN | Pessac, 33604, France Recruiting
CHU La Miletrie | Poitiers Cedex, 86021, France Recruiting
ICANS - Institut de cancérologie Strasbourg Europe | Strasbourg, 67200, France Recruiting
Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse Cedex 9, 31059, France Recruiting
Unviversitatsklinikum Aachen | Aachen, 52074, Germany Not yet recruiting
Stauferklinikum Schwab. Gmund | Baden-Warttemberg, 73557, Germany Recruiting
Universitaetsklinikum Duesseldorf | Dusseldorf, 40225, Germany Not yet recruiting
Universitatsklinikum Halle Saale | Halle, 06120, Germany Not yet recruiting
OncoResearch Lerchenfeld GmbH | Hamburg, 22081, Germany Recruiting
Universitaetsklinikum Jena | Jena, 07740, Germany Recruiting
Universitatsklinikum Leipzig | Leipzig, 04103, Germany Not yet recruiting
Universitaetsklinikum Mannheim | Mannheim, 68167, Germany Recruiting
Johannes Wiesling Klinikum Minden | Minden, 32429, Germany Not yet recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie | Münster, 48149, Germany Not yet recruiting
University Hospital of Alexandroupolis | Alexandroupolis, 08100, Greece Recruiting
Evangelismos General Hospital of Athens | Athens, 10676, Greece Recruiting
Laiko General Hospital of Athens | Athens, 11 527, Greece Recruiting
Attikon university General Hospital | Athens, 12464, Greece Recruiting
University General Hospital of Patras | Rio Patras, 26500, Greece Recruiting
Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki, 57010, Greece Recruiting
Queen Mary Hospital | Hong Kong, Hong Kong Recruiting
Prince of Wales Hospital the Chinese University of Hong Kong | Sha Tin, Hong Kong Not yet recruiting
Mercy University Hospital | Cork, D11 KXN4, Ireland Not yet recruiting
Mater Misercordiae Hospital | Dublin 7, 7, Ireland Recruiting
St James Hospital | Dublin, Dublin 8, Ireland Recruiting
Rambam Medical Center | Haifa, 31096, Israel Recruiting
Hadassah Medical Organization | Jerusalem, 91120, Israel Recruiting
Meir Medical Center | Kfar-Saba, 44281, Israel Recruiting
Tel-Aviv Sourasky Medical Center | Tel-Aviv, 64239, Israel Recruiting
Shamir Medical Center - Assaf Harofeh | Zerifin, 70300, Israel Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi | Ancona, 60126, Italy Recruiting
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi | Bologna, 40138, Italy Recruiting
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico | Catania, 95123, Italy Not yet recruiting
Azienda Ospedaliera Universitaria Careggi | Firenze, 50134, Italy Recruiting
Azienda Ospedaliera Universitaria Federico II | Napoli, Campania, 80131, Italy Recruiting
A.O.U. Maggiore della Carità | Novara, 28100, Italy Not yet recruiting
Azienda Ospedaliera di Padova | Padova, 35128, Italy Not yet recruiting
Azienda Ospedaliero Universitaria Pisana | Pisa, 56124, Italy Not yet recruiting
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli | Reggio Di Calabria, 89124, Italy Not yet recruiting
Azienda Ospedaliera Sant Andrea | Roma, 00189, Italy Not yet recruiting
Ospedale S Eugenio | Roma, 144, Italy Not yet recruiting
Azienda Ospedaliera S Maria di Terni | Terni, 05100, Italy Recruiting
Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese | Varese, 21100, Italy Recruiting
Aomori Prefectural Central Hospital | Aomori, 030-8553, Japan Recruiting
Juntendo University Hospital | Bunkyo-ku, 113-8431, Japan Recruiting
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Bunkyo-ku, 113-8677, Japan Not yet recruiting
University of Yamanashi Hospital | Chuo, 409-3898, Japan Recruiting
Tokai University Hospital | Isehara City, Kanagawa, 259-1193, Japan Recruiting
Kameda General Hospital | Kamogawa, 296-8602, Japan Recruiting
Gunma University Hospital | Maebashi, 371-8511, Japan Recruiting
University of Miyazaki Hospital | Miyazaki, 889-1692, Japan Recruiting
The Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki, 852-8511, Japan Recruiting
Kindai University Hospital | Osaka-Sayama, 589-8511, Japan Recruiting
Osaka City University Hospital | Osaka, 545-8586, Japan Recruiting
Sapporo Hokuyu Hospital | Sapporo, 003-0006, Japan Recruiting
NTT Medical Center Tokyo | Shinagawa-ku, Tokyo, 141-8625, Japan Recruiting
Tokyo Women's Medical University Hospital | Shinjuku City, 162-8666, Japan Recruiting
Tokyo Medical University Hospital | Shinjyuku-ku, 160-0023, Japan Recruiting
Kyungpook National University Hospital | Daegu, 700-721, Korea, Republic of Recruiting
Chonnam National University Hwasun Hospital | Hwasun-Gun, 58128, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea, Republic of Recruiting
Samsung Medical Center | Seoul, 135-710, Korea, Republic of Recruiting
The Catholic University of Korea Seoul - Saint Mary's Hospital | Seoul, 137-701, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 3080, Korea, Republic of Recruiting
Asan Medical Center | Seoul, 5505, Korea, Republic of Recruiting
Uniwersyteckie Centrum Kliniczne | Gdansk, 80-952, Poland Not yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Krakow, 31-501, Poland Not yet recruiting
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lodz, 93-510, Poland Not yet recruiting
ALVAMED | Poznan, 61-696, Poland Not yet recruiting
Specjalistyczny Szpital im. dra Alfreda Sokolowskiego | Walbrzych, 58-309, Poland Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw, 50367, Poland Not yet recruiting
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin | Moscow, 125284, Russian Federation Recruiting
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov | St Petersburg, 197341, Russian Federation Not yet recruiting
First St Petersburg State Medical University na IP Pavlov | St. Petersburg, 197022, Russian Federation Recruiting
Hospital Clinic de Barcelona | Barcelona, 08036, Spain Recruiting
Hospital Universitari Germans Trias i Pujol ICO Badalona | Barcelona, 08916, Spain Not yet recruiting
Hospital Virgenes de las Nieves | Granada, 18014, Spain Recruiting
Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria, 35012, Spain Recruiting
Hospital Universitario Ramon y Cajal | Madrid, 28034, Spain Recruiting
Hospital Universitario 12 de Octubre | Madrid, 28041, Spain Recruiting
Hospital Son Espases | Palma de Mallorca, 7120, Spain Recruiting
Universitario de Salamanca - Hospital Clinico | Salamanca, 37007, Spain Recruiting
Complejo Hospitalario Universitario de Santiago | Santiago de Compostela, 15706, Spain Recruiting
Hospital Universitario Virgen del Rocio | Seville, 41013, Spain Recruiting
Hospital Clinico Universitario de Valencia | Valencia, 46010, Spain Recruiting
Heart of England NHS Foundation Trust | Birmingham, B9 5SS, United Kingdom Not yet recruiting
United Lincolnshire Hospitals NHS Trust | Boston, PE21 9QS, United Kingdom Not yet recruiting
Guy's Cancer Centre | London, SE1 9RT, United Kingdom Not yet recruiting
Nottingham City Hospital | Nottingham, NG5 1PB, United Kingdom Recruiting
Churchhill Hospital | Oxford, OX3 7LI, United Kingdom Not yet recruiting
Location Countries

Australia

Austria

Belgium

Canada

China

Czechia

France

Germany

Greece

Hong Kong

Ireland

Israel

Italy

Japan

Korea, Republic of

Poland

Russian Federation

Spain

United Kingdom

United States

Verification Date

2021-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental Arm: Luspatercept (ACE-536)

Type: Experimental

Description: Luspatercept will be given to participants via subcutaneous injection (administered on Day 1 of each 21-day treatment cycle)

Label: Control Arm: Placebo

Type: Placebo Comparator

Description: Placebo starting dose with volume equivalent to experimental arm subcutaneous injection every 3 weeks (administered on Day 1 of each 21-day treatment cycle)

Acronym INDEPENDENCE
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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