NCT03682536

Brief Summary

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
363

participants targeted

Target at P50-P75 for phase_3

Timeline
17mo left

Started Jan 2019

Longer than P75 for phase_3

Geographic Reach
25 countries

224 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2019Sep 2027

First Submitted

Initial submission to the registry

September 7, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 26, 2024

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2027

Expected
Last Updated

November 20, 2024

Status Verified

October 1, 2024

Enrollment Period

4.2 years

First QC Date

September 7, 2018

Results QC Date

March 28, 2024

Last Update Submit

November 4, 2024

Conditions

Keywords

LuspaterceptACE-536AnemiaMyelodysplastic SyndromesBlood TransfusionRBC TransfusionErythropoiesis-stimulating agentsErythropoietinMyelodysplasiaEpoetin alpha

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase ≥ 1.5 g/dL

    Percentage of participants who are RBC transfusion-free for any 12-week period associated with a concurrent mean hemoglobin (Hgb) increase ≥ 1.5 g/dL compared to baseline. After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated. 4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being \< 14 days after the previous transfusion.

    Week 1 through Week 24

Secondary Outcomes (20)

  • Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 24 Weeks

    Week 1 through Week 24

  • Mean Hemoglobin Change Over 24 Weeks

    Week 1 through Week 24

  • Percentage of Participants Achieving Hematologic Improvement - Erythroid Response (HI-E) Per IWG

    Week 1 through Week 24

  • Time to Hematologic Improvement - Erythroid Response (HI-E)

    Week 1 through Week 24

  • Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 12 Weeks (84 Days)

    Week 1 through Week 24

  • +15 more secondary outcomes

Study Arms (2)

Luspatercept

EXPERIMENTAL
Drug: Luspatercept

Epoetin alfa

ACTIVE COMPARATOR
Drug: Epoetin alfa

Interventions

Specified dose on specified days

Also known as: ACE-536
Luspatercept

Specified dose on specified days

Also known as: EPREX®, ERYPO®, PROCRIT®
Epoetin alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have \< 5% blasts in bone marrow
  • Endogenous serum erythropoietin (sEPO) level of \< 500 U/L
  • Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2

You may not qualify if:

  • Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
  • Known history of diagnosis of Acute myeloid leukemia (AML)
  • Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (226)

Local Institution - 107

Berkeley, California, 94704, United States

Location

Local Institution - 115

San Diego, California, 92123, United States

Location

Local Institution - 101

Whittier, California, 90603, United States

Location

Local Institution - 104

New Haven, Connecticut, 06520, United States

Location

Local Institution - 136

Washington D.C., District of Columbia, 20422, United States

Location

Local Institution - 119

Hudson, Florida, 34667, United States

Location

Local Institution - 120

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 122

Tallahassee, Florida, 32308, United States

Location

Local Institution - 108

Tampa, Florida, 33612, United States

Location

Local Institution - 118

West Palm Beach, Florida, 33401, United States

Location

Local Institution - 102

Paducah, Kentucky, 42003, United States

Location

Local Institution - 123

Bethesda, Maryland, 20817, United States

Location

Local Institution - 117

Kansas City, Missouri, 64132, United States

Location

Local Institution - 134

East Brunswick, New Jersey, 08816, United States

Location

Local Institution - 113

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 105

Greenville, North Carolina, 27858-4354, United States

Location

Local Institution - 131

Portland, Oregon, 97213, United States

Location

Univ of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 111

Rock Hill, South Carolina, 29732, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203-1625, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Local Institution - 109

Houston, Texas, 77030, United States

Location

Local Institution - 114

Salt Lake City, Utah, 84106, United States

Location

Local Institution - 132

Charlottesville, Virginia, 22903, United States

Location

Local Institution - 127

Chesapeake, Virginia, 23320, United States

Location

Local Institution - 206

Albury, New South Wales, 2640, Australia

Location

Local Institution - 213

Blacktown, New South Wales, 2148, Australia

Location

Local Institution - 200

Concord, New South Wales, 2139, Australia

Location

Local Institution - 215

Kogarah, New South Wales, 2217, Australia

Location

Local Institution - 211

Nowra, New South Wales, 2541, Australia

Location

Local Institution - 210

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 207

Wollongong, New South Wales, 2500, Australia

Location

Local Institution - 208

Auchenflower, Queensland, 4066, Australia

Location

Local Institution - 202

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 204

Clayton, Victoria, 3168, Australia

Location

Local Institution - 203

Malvern, Victoria, 3144, Australia

Location

Local Institution - 209

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 205

West Perth, Western Australia, 6005, Australia

Location

Local Institution - 212

Randwick, 2031, Australia

Location

Local Institution - 442

Linz, 4020, Austria

Location

Local Institution - 441

Vienna, 1090, Austria

Location

Local Institution - 475

Antwerp, 2020, Belgium

Location

Local Institution - 471

Brasschaat, 2930, Belgium

Location

Local Institution - 474

Brussels, 1200, Belgium

Location

Local Institution - 472

Charleroi, 6000, Belgium

Location

Local Institution - 473

Kortrijk, 8500, Belgium

Location

Local Institution - 470

Leuven, 3000, Belgium

Location

Local Institution - 476

Roeselare, 8800, Belgium

Location

Local Institution - 147

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 145

Edmonton, Alberta, T6G 2B7, Canada

Location

Local Institution - 142

Hamilton, Ontario, L8V 5C2, Canada

Location

Local Institution - 140

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 141

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution - 144

Montreal, Quebec, H1T 2M4, Canada

Location

Local Institution - 148

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 151

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Local Institution - 152

Sherbrooke, J1H 5N4, Canada

Location

Local Institution - 560

Hradec Králové, 500 05, Czechia

Location

Local Institution - 564

Ostrava-Poruba, 708 52, Czechia

Location

Local Institution - 563

Prague, 100 34, Czechia

Location

Local Institution - 562

Prague, 128 08, Czechia

Location

Local Institution - 561

Prague, 128 20, Czechia

Location

Local Institution - 317

Angers, 49000, France

Location

Local Institution - 312

Bayonne, 64109, France

Location

Local Institution - 311

Caen, 14033, France

Location

Local Institution - 306

La Tronche, 38700, France

Location

Local Institution - 305

Le Mans, 72037, France

Location

Local Institution - 309

Lille, 59037, France

Location

Local Institution - 303

Limoges, 87042, France

Location

Local Institution - 307

Nantes, 44093, France

Location

Local Institution - 301

Nice, 06200, France

Location

Local Institution - 302

Paris, 75010, France

Location

Local Institution - 313

Paris, 75014, France

Location

Local Institution - 308

Pessac, 33604, France

Location

Local Institution - 315

Pierre-Bénite, 69495, France

Location

Local Institution - 316

Poitiers, 86021, France

Location

Local Institution - 314

Strasbourg, 67033, France

Location

Local Institution - 300

Toulouse, 31059, France

Location

Local Institution - 310

Tours, 37044, France

Location

Local Institution - 304

Vandœuvre-lès-Nancy, 54511, France

Location

Local Institution - 422

Baden-Warttemberg, 73557, Germany

Location

Local Institution - 424

Berlin, 14195, Germany

Location

Local Institution - 428

Cologne, 50677, Germany

Location

Local Institution - 426

Dresden, 01307, Germany

Location

Local Institution - 429

Duisburg, 47166, Germany

Location

Local Institution - 420

Düsseldorf, 40479, Germany

Location

Local Institution - 431

Hamburg, 22081, Germany

Location

Local Institution - 435

Keil, 24105, Germany

Location

Local Institution - 423

Koblenz, 56068, Germany

Location

Local Institution - 430

Leipzig, 04103, Germany

Location

Local Institution - 436

Mannheim, 68167, Germany

Location

Local Institution - 421

München, 81675, Germany

Location

Local Institution - 425

Winnenden, 71364, Germany

Location

Local Institution - 427

Würzburg, 97070, Germany

Location

Local Institution - 389

Heraklion, Irakleio, 71110, Greece

Location

Local Institution - 396

Alexandroupoli, 08100, Greece

Location

Local Institution - 397

Athens, 10676, Greece

Location

Local Institution - 391

Athens, 115 27, Greece

Location

Local Institution - 395

Athens, 115 27, Greece

Location

Local Institution - 392

Athens, 12464, Greece

Location

Local Institution - 398

Pátrai, 26500, Greece

Location

Local Institution - 393

Rio Patras, 26500, Greece

Location

Local Institution - 399

Thessaloniki, 546 36, Greece

Location

Local Institution - 390

Thessaloniki, 57010, Greece

Location

Local Institution - 535

Budapest, 1096, Hungary

Location

Local Institution - 534

Debrecen, 4032, Hungary

Location

Local Institution - 536

Nyíregyháza, 4400, Hungary

Location

Local Institution - 386

Haifa, 34362, Israel

Location

Local Institution - 383

Jerusalem, 9103102, Israel

Location

Local Institution - 384

Jerusalem, 91120, Israel

Location

Local Institution - 381

Kfar Saba, 44281, Israel

Location

Local Institution - 385

Nahariya, 22100, Israel

Location

Local Institution - 382

Tel Aviv, 64239, Israel

Location

Local Institution - 380

Ẕerifin, 70300, Israel

Location

Local Institution - 331

Orbassano, TO, 10043, Italy

Location

Local Institution - 324

Bologna, 40138, Italy

Location

Local Institution - 327

Florence, 50134, Italy

Location

Local Institution - 330

Meldola, 47014, Italy

Location

Local Institution - 321

Milan, 20162, Italy

Location

Local Institution - 329

Padua, 35128, Italy

Location

Local Institution - 326

Reggio Calabria, 89124, Italy

Location

Local Institution - 328

Roma, 00133, Italy

Location

Local Institution - 332

Roma, 00189, Italy

Location

Local Institution - 325

Rome, 00161, Italy

Location

Local Institution - 323

Rozzano, 20089, Italy

Location

Local Institution - 322

Udine, 33100, Italy

Location

Local Institution - 238

Matsuyama, Ehime, 790-8524, Japan

Location

Local Institution - 244

Nagasaki, Nagasaki, 8528511, Japan

Location

Local Institution - 236

Sayama, Osaka, 5898511, Japan

Location

Local Institution - 247

Amagasaki-Shi, 660-0892, Japan

Location

Local Institution - 249

Fujisawa-Shi, 251-0052, Japan

Location

Local Institution - 234

Fukuoka, 810-8563, Japan

Location

Local Institution - 237

Hitachi, Ibaraki, 317-0077, Japan

Location

Local Institution - 231

Kamogawa, 296-8602, Japan

Location

Local Institution - 248

Kitakyushu-Shi, 806-0034, Japan

Location

Local Institution - 270

Nagaoka-Shi, 940-2108, Japan

Location

Local Institution - 243

Nagoya, 460-0001, Japan

Location

Local Institution - 235

Okayama, 700-8557, Japan

Location

Local Institution - 242

Osaka, 545-8586, Japan

Location

Local Institution - 241

Ōgaki, 503-8502, Japan

Location

Local Institution - 233

Sagamihara, 252-0375, Japan

Location

Local Institution - 246

Sapporo, 064-0804, Japan

Location

Local Institution - 239

Sendai, 980-8574, Japan

Location

Local Institution - 232

Shibuya-ku, 150-8935, Japan

Location

Local Institution - 245

Shimotsuga-gun, 321-0293, Japan

Location

Local Institution - 230

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Local Institution - 540

Kaunas, LT-50009, Lithuania

Location

Local Institution - 541

Vilnius, LT-08661, Lithuania

Location

Local Institution - 462

Amsterdam, 1081 HV, Netherlands

Location

Local Institution - 464

Nijmegen, 6525 GA, Netherlands

Location

Local Institution - 460

Rotterdam, 3015 CE, Netherlands

Location

Local Institution - 463

Sittard-Geleen, 6162 BG, Netherlands

Location

Local Institution - 461

The Hague, 2545 CH, Netherlands

Location

Local Institution - 570

Lodz, Lódzkie, 93-513, Poland

Location

Local Institution - 575

Gdansk, 80-952, Poland

Location

Local Institution - 572

Lubin, 20-081, Poland

Location

Local Institution - 576

Poznan, 60-569, Poland

Location

Local Institution - 573

Rzwszow, 35-055, Poland

Location

Local Institution - 579

Słupsk, 76-200, Poland

Location

Local Institution - 578

Wałbrzych, 58-309, Poland

Location

Local Institution - 577

Wroclaw, 50-367, Poland

Location

Local Institution - 571

Wroclaw, 50-556, Poland

Location

Local Institution - 373

Beja, 7801-849, Portugal

Location

Local Institution - 371

Braga, 4710-243, Portugal

Location

Local Institution - 372

Lisbon, 1099-023, Portugal

Location

Local Institution - 370

Porto, 4200-072, Portugal

Location

Local Institution - 374

Setúbal, 2910-446, Portugal

Location

Local Institution - 511

Kaluga, 248007, Russia

Location

Local Institution - 505

Kirov, 610027, Russia

Location

Local Institution - 509

Krasnoyarsk, 660022, Russia

Location

Local Institution - 504

Moscow, 111123, Russia

Location

Local Institution - 507

Moscow, 123182, Russia

Location

Local Institution - 500

Moscow, 125284, Russia

Location

Local Institution - 503

Moscow, 129301, Russia

Location

Local Institution - 510

Saint Petersburg, 197022, Russia

Location

Local Institution - 506

Saint Petersburg, 197341, Russia

Location

Local Institution - 508

Saratov, 410012, Russia

Location

Local Institution - 502

Tula, 300053, Russia

Location

Local Institution - 251

Busan, 49241, South Korea

Location

Local Institution - 257

Daegu, 700-721, South Korea

Location

Local Institution - 250

Hwasun-Gun, 58128, South Korea

Location

Local Institution - 253

Seongnam-si, 13620, South Korea

Location

Local Institution - 252

Seoul, 06351, South Korea

Location

Local Institution - 256

Seoul, 06591, South Korea

Location

Local Institution - 255

Seoul, 3080, South Korea

Location

Local Institution - 254

Seoul, 5505, South Korea

Location

Local Institution - 358

Barcelona, 08035, Spain

Location

Local Institution - 350

Barcelona, 08908, Spain

Location

Local Institution - 354

Granada, 18014, Spain

Location

Local Institution - 352

Madrid, 28007, Spain

Location

Local Institution - 355

Madrid, 28041, Spain

Location

Local Institution - 353

Málaga, 29010, Spain

Location

Local Institution - 361

Murcia, 30008, Spain

Location

Local Institution - 356

Ourense, 32005, Spain

Location

Local Institution - 363

Oviedo, 33011, Spain

Location

Local Institution - 362

Palma de Mallorca, 7120, Spain

Location

Local Institution - 351

Salamanca, 37007, Spain

Location

Local Institution - 360

Seville, 41013, Spain

Location

Local Institution - 357

Valencia, 46010, Spain

Location

Local Institution - 359

Valencia, 46026, Spain

Location

Local Institution - 550

Gothenburg, SE-413 45, Sweden

Location

Local Institution - 552

Lund, SE-221 85, Sweden

Location

Local Institution - 551

Stockholm, SE-141 86, Sweden

Location

Local Institution - 450

Bern, 3010, Switzerland

Location

Local Institution - 452

Lucerne, 6000, Switzerland

Location

Local Institution - 451

Winterthur, 8400, Switzerland

Location

Local Institution - 220

Changhua City, Changhua, 500, Taiwan

Location

Local Institution - 222

Niaosong District Kaohsiung City, 83301, Taiwan

Location

Local Institution - 223

Taichung, 40447, Taiwan

Location

Local Institution - 224

Taichung, 40705, Taiwan

Location

Local Institution - 221

Taipei, 100225, Taiwan

Location

Local Institution - 342

Ankara, 06100, Turkey (Türkiye)

Location

Local Institution - 340

Manisa, 45030, Turkey (Türkiye)

Location

Local Institution - 343

Trabzon, 61080, Turkey (Türkiye)

Location

Local Institution - 526

Cherkassy, 18009, Ukraine

Location

Local Institution - 525

Dnipro, 49102, Ukraine

Location

Local Institution - 522

Kyiv, 3115, Ukraine

Location

Local Institution - 520

Lviv, 79044, Ukraine

Location

Local Institution - 523

Mykolaiv, 54058, Ukraine

Location

Local Institution - 521

Ternopil, 46002, Ukraine

Location

Local Institution - 401

Aberdeen, AB25 2ZN, United Kingdom

Location

Local Institution - 403

Bournemouth, BH7 7DW, United Kingdom

Location

Local Institution - 405

Headington, Oxford, OX3 7LE, United Kingdom

Location

Local Institution - 407

Lincoln, LN2 5QY, United Kingdom

Location

Local Institution - 404

London, SE5 9RS, United Kingdom

Location

Local Institution - 400

Manchester, M20 4BX, United Kingdom

Location

Related Publications (4)

  • Komrokji RS, Hayati S, Ugidos M, Garcia-Manero G, Della Porta MG, Zeidan AM, Santini V, Platzbecker U, Gandhi AK, Suragani RNVS. Impact of Mutational Landscape and Burden on RBC Transfusion Response in Patients With Lower-Risk Myelodysplastic Syndromes (LR-MDS) in the COMMANDS Study. Am J Hematol. 2026 Jan 19. doi: 10.1002/ajh.70171. Online ahead of print.

  • Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Pozharskaya V, Rose S, Keeperman K, Lai Y, Kalsekar S, Aggarwal B, Miteva D, Valcarcel D, Fenaux P, Shortt J, Della Porta MG, Platzbecker U. Long-Term Transfusion Independence with Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent-Naive, Lower-Risk Myelodysplastic Syndromes in the COMMANDS Trial. Adv Ther. 2025 Jul;42(7):3576-3589. doi: 10.1007/s12325-025-03208-5. Epub 2025 May 16.

  • Della Porta MG, Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Pilot R, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Prebet T, Lai Y, Degulys A, Paolini S, Cluzeau T, Fenaux P, Platzbecker U. Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Sep;11(9):e646-e658. doi: 10.1016/S2352-3026(24)00203-5. Epub 2024 Jul 19.

  • Platzbecker U, Della Porta MG, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Giuseppi AC, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Shetty JK, Hayati S, Vodala S, Prebet T, Degulys A, Paolini S, Cluzeau T, Fenaux P, Garcia-Manero G. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. Lancet. 2023 Jul 29;402(10399):373-385. doi: 10.1016/S0140-6736(23)00874-7. Epub 2023 Jun 10.

Related Links

MeSH Terms

Conditions

Myelodysplastic SyndromesAnemiaAnemia, Refractory, with Excess of Blasts

Interventions

luspaterceptEpoetin Alfa

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia, Refractory

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 24, 2018

Study Start

January 2, 2019

Primary Completion

March 31, 2023

Study Completion (Estimated)

September 28, 2027

Last Updated

November 20, 2024

Results First Posted

June 26, 2024

Record last verified: 2024-10

Locations