A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

NCT05582395 | Completed Phase 3 DMC FDA Drug

• 3 other identifiers: CV027-031U1111-1269-85812023-506352-24
• Study Type: interventional
• Target: 580
• Locations: 22 countries
• Sites: 217

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

Conditions

Cardiomyopathy, Hypertrophic

Keywords

Mavacamten; non-obstructive HCM; non-obstructive hypertrophic cardiomyopathy (nHCM)

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48

  Up to Week 48

• Change from baseline in peak oxygen consumption (pVO2) at Week 48

  Up to Week 48

Secondary Outcomes (4)

• Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48

  Up to Week 48

• Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48

  Up to Week 48

• Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48

  Up to Week 48

• Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48

  Up to Week 48

Study Arms (2)

Mavacamten

EXPERIMENTAL

Drug: Mavacamten

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Mavacamten DRUG

Specified dose on specified days

Also known as: BMS-986427, MYK-461

Mavacamten

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy \[HCM\]) as determined by core laboratory interpretation.
• Peak left ventricular outflow tract (LVOT) pressure gradient \< 30 millimeters mercury (mm Hg) at rest and \< 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography).
• New York Heart Association (NYHA) Class II or III.

You may not qualify if:

• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
• History of unexplained syncope within 6 months prior to screening.
• History of sustained ventricular tachyarrhythmia (\> 30 seconds) within 6 months prior to screening.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (224)

Local Institution - 0082

Birmingham, Alabama, 35233-1900, United States

Location

Local Institution - 0458

Phoenix, Arizona, 85054, United States

Location

Local Institution - 0409

La Jolla, California, 92037-1337, United States

Location

Local Institution - 0010

Los Angeles, California, 90048-3311, United States

Location

Local Institution - 0406

San Francisco, California, 94143-2204, United States

Location

Local Institution - 0079

Stanford, California, 94305-2200, United States

Location

Local Institution - 0468

Gainesville, Florida, 32608-1134, United States

Location

Local Institution - 0281

Tampa, Florida, 33606-3603, United States

Location

Local Institution - 0092

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0424

Indianapolis, Indiana, 46202-1243, United States

Location

Local Institution - 0070

Iowa City, Iowa, 52242-1009, United States

Location

Local Institution - 0410

Kansas City, Kansas, 66160-8500, United States

Location

Local Institution - 0484

Louisville, Kentucky, 40217-1363, United States

Location

Local Institution - 0127

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0479

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0500

Boston, Massachusetts, 02118-2908, United States

Location

Local Institution - 0464

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0064

Detroit, Michigan, 48202-2608, United States

Location

Local Institution - 0455

Grand Rapids, Michigan, 49525, United States

Location

Local Institution - 0431

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0461

St Louis, Missouri, 63110, United States

Location

Local Institution - 0435

Omaha, Nebraska, 68198-2265, United States

Location

Local Institution - 0490

Morristown, New Jersey, 07962, United States

Location

Local Institution - 0449

Manhasset, New York, 11030-3816, United States

Location

Local Institution - 0486

New York, New York, 10019-1147, United States

Location

Local Institution - 0007

Stony Brook, New York, 11790-3407, United States

Location

Local Institution - 0426

Valhalla, New York, 10595, United States

Location

Local Institution - 0094

Charlotte, North Carolina, 28204-2826, United States

Location

Local Institution - 0065

Durham, North Carolina, 27710, United States

Location

Local Institution - 0083

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0047

Hershey, Pennsylvania, 17033, United States

Location

Local Institution - 0444

Lancaster, Pennsylvania, 17602-2250, United States

Location

Local Institution - 0263

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0081

Pittsburgh, Pennsylvania, 15213-2536, United States

Location

Local Institution - 0207

Germantown, Tennessee, 38138-1727, United States

Location

Local Institution - 0089

Dallas, Texas, 75246, United States

Location

Local Institution - 0365

Dallas, Texas, 75390, United States

Location

Local Institution - 0492

Plano, Texas, 75093, United States

Location

Local Institution - 0402

Salt Lake City, Utah, 84132-0001, United States

Location

Local Institution - 0478

Charlottesville, Virginia, 22908-0001, United States

Location

Local Institution - 0095

Richmond, Virginia, 23298-5024, United States

Location

Local Institution - 0063

Concord, New South Wales, 2139, Australia

Location

Local Institution - 0085

Darlinghurst, New South Wales, 2010, Australia

Location

Local Institution - 0369

Sydney, New South Wales, 2170, Australia

Location

Local Institution - 0080

Chermside, Queensland, 4032, Australia

Location

Local Institution - 0078

Milton, Queensland, 4064, Australia

Location

Local Institution - 0050

Bedford Park, South Australia, 5042, Australia

Location

Local Institution - 0076

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0090

Innsbruck, Tyrol, 6020, Austria

Location

Local Institution - 0075

Linz, Upper Austria, 4020, Austria

Location

Local Institution - 0069

Braunau am Inn, Upper Austria (Oberösterreich), 5280, Austria

Location

Local Institution - 0062

Graz, 8036, Austria

Location

Local Institution - 0429

Vienna, 1090, Austria

Location

Local Institution - 0462

Edegem, Antwerpen, 2650, Belgium

Location

Local Institution - 0034

Anderlecht, Brussels Capital, 1070, Belgium

Location

Local Institution - 0476

Genk, Limburg, 3600, Belgium

Location

Local Institution - 0319

Leuven, Vlaams Brabant, 3000, Belgium

Location

Local Institution - 0413

Salvador, Estado de Bahia, 40170-130, Brazil

Location

Local Institution - 0438

Brasília, Federal District, 70710-140, Brazil

Location

Local Institution - 0488

Belo Horizonte, Minas Gerais, 30220-140, Brazil

Location

Local Institution - 0447

Porto Alegre, Rio Grande do Sul, 90560-030, Brazil

Location

Local Institution - 0450

Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

Location

Local Institution - 0430

Bragança Paulista, São Paulo, 12916-542, Brazil

Location

Local Institution - 0422

Ribeirão Preto, São Paulo, 14026-900, Brazil

Location

Local Institution - 0412

São Paulo, São Paulo, 05403-000, Brazil

Location

Local Institution - 0446

Rio de Janeiro, 20551-030, Brazil

Location

Local Institution - 0451

Rio de Janeiro, 22061-080, Brazil

Location

Local Institution - 0418

São Paulo, 04012-180, Brazil

Location

Local Institution - 0381

Calgary, Alberta, T2N 1N4, Canada

Location

Local Institution - 0467

Vancouver, British Columbia, V6E 1M7, Canada

Location

Local Institution - 0414

Hamilton, Ontario, L8L 2X2, Canada

Location

Local Institution - 0411

London, Ontario, N6A 5A5, Canada

Location

Local Institution - 0093

Québec, Quebec, G1V 4G5, Canada

Location

Local Institution - 0535

Beijing, Beijing Municipality, 100083, China

Location

Local Institution - 0534

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 0503

Chongqing, Chongqing Municipality, 400016, China

Location

Local Institution - 0541

Chongqing, Chongqing Municipality, 400016, China

Location

Local Institution - 0539

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 0543

Guangzhou, Guangdong, 510515, China

Location

Local Institution - 0549

Zhengzhou, Henan, 450003, China

Location

Local Institution - 0542

Wuhan, Hubei, 430060, China

Location

Local Institution - 0548

Changsha, Hunan, 410011, China

Location

Local Institution - 0545

Suzhou, Jiangsu, 215006, China

Location

Local Institution - 0550

Nanchang, Jiangxi, 330008, China

Location

Local Institution - 0544

Changchun, Jilin, 130041, China

Location

Local Institution - 0540

Dalian, Liaoning, 116011, China

Location

Local Institution - 0501

Shenyang, Liaoning, 110016, China

Location

Local Institution - 0538

Shenyang, Liaoning, 110016, China

Location

Local Institution - 0547

Xi'an, Shan1xi, 710061, China

Location

Local Institution - 0546

Jinan, Shandong, 250021, China

Location

Local Institution - 0537

Shanghai, Shanghai Municipality, 200127, China

Location

Local Institution - 0533

Chengdu, Sichuan, 610000, China

Location

Local Institution - 0552

Chengdu, Sichuan, 610015, China

Location

Local Institution - 0536

Wenzhou, Zhejiang, 325000, China

Location

Local Institution - 0502

Beijing, 100730, China

Location

Local Institution - 0553

Beijing, 102218, China

Location

Local Institution - 0086

Broumov, Královéhradecký kraj, 550 01, Czechia

Location

Local Institution - 0052

Prague, Praha, Hlavní Mesto, 128 21, Czechia

Location

Local Institution - 0033

Prague, Praha, Hlavní Mesto, 140 21, Czechia

Location

Local Institution - 0188

Brno, 656 91, Czechia

Location

Local Institution - 0045

Aalborg, North Denmark, DK-9000, Denmark

Location

Local Institution - 0428

Aabenraa, Sønderjylland, 6200, Denmark

Location

Local Institution - 0019

Aarhus N, 8200, Denmark

Location

Local Institution - 0001

Nice, Alpes-Maritimes, 06000, France

Location

Local Institution - 0463

Brest, Finistère, 29200, France

Location

Local Institution - 0005

Toulouse, Haute-Garonne, 31400, France

Location

Local Institution - 0003

Chambray-lès-Tours, Indre-et-Loire, 37044, France

Location

Local Institution - 0489

La Tronche, Isère, 38700, France

Location

Local Institution - 0067

Bron, Rhône, 69500, France

Location

Local Institution - 0009

Nantes, 44093, France

Location

Local Institution - 0004

Paris, 75013, France

Location

Local Institution - 0006

Paris, 75015, France

Location

Local Institution - 0053

Pessac, 33604, France

Location

Local Institution - 0008

Rennes, 35000, France

Location

Local Institution - 0404

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Local Institution - 0022

München, Bavaria, 81377, Germany

Location

Local Institution - 0440

Regensburg, Bavaria, 93053, Germany

Location

Local Institution - 0013

Bad Nauheim, Hesse, 61231, Germany

Location

Local Institution - 0496

Göttingen, Lower Saxony, 37075, Germany

Location

Local Institution - 0448

Hanover, Lower Saxony, 30625, Germany

Location

Local Institution - 0273

Cologne, North Rhine Wesrphalia, 50924, Germany

Location

Local Institution - 0439

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Local Institution - 0174

Bielefeld, North Rhine-Westphalia, 33604, Germany

Location

Local Institution - 0420

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Local Institution - 0066

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Local Institution - 0016

Jena, Thuringia, 07747, Germany

Location

Local Institution - 0403

Berlin, 13353, Germany

Location

Local Institution - 0071

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 0032

Hamburg, 20246, Germany

Location

Local Institution - 0077

Heidelberg, 69120, Germany

Location

Local Institution - 0454

München, 80636, Germany

Location

Local Institution - 0046

Münster, 48149, Germany

Location

Local Institution - 0423

Balatonfüred, Veszprém megye, 8230, Hungary

Location

Local Institution - 0048

Budapest, 1096, Hungary

Location

Local Institution - 0039

Budapest, 1097, Hungary

Location

Local Institution - 0035

Budapest, 1122, Hungary

Location

Local Institution - 0417

Szeged, 6720, Hungary

Location

Local Institution - 0482

Ahmedabad, Gujarat, 380060, India

Location

Local Institution - 0480

Bengaluru, Karnataka, 560099, India

Location

Local Institution - 0481

Kochi, Kerala, 682001, India

Location

Local Institution - 0483

Chandigarh, 160012, India

Location

Local Institution - 0330

Gūrgaon, 122 001, India

Location

Local Institution - 0025

Jerusalem, Jerusalem, 90000, Israel

Location

Local Institution - 0057

Jerusalem, Jerusalem, 9103102, Israel

Location

Local Institution - 0026

Ashkelon, Tel Aviv, 7830604, Israel

Location

Local Institution - 0037

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Local Institution - 0419

Haifa, 3109601, Israel

Location

Local Institution - 0427

Petah Tikva, 49100, Israel

Location

Local Institution - 0074

Ramat Gan, 5265601, Israel

Location

Local Institution - 0054

Rehovot, 76100, Israel

Location

Local Institution - 0253

Safed, 13100, Israel

Location

Local Institution - 0373

Florence, Tuscany, 50139, Italy

Location

Local Institution - 0171

Pisa, 56124, Italy

Location

Local Institution - 0028

Roma, 00189, Italy

Location

Local Institution - 0370

Uwajima, Ehime, 798-8510, Japan

Location

Local Institution - 0208

Himeji-Shi, Hyōgo, 672-8044, Japan

Location

Local Institution - 0457

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Local Institution - 0107

Yokohama, Kanagawa, 227-8501, Japan

Location

Local Institution - 0119

Nankoku-shi, Kochi, 783-8505, Japan

Location

Local Institution - 0453

Tsu, Mie-ken, 514-8507, Japan

Location

Local Institution - 0456

Sendai, Miyagi, 980-8574, Japan

Location

Local Institution - 0452

Osaka, Osaka, 545-0051, Japan

Location

Local Institution - 0315

Suita, Osaka, 564-8565, Japan

Location

Local Institution - 0471

Takatsuki-Shi, Osaka, 569-8686, Japan

Location

Local Institution - 0168

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Local Institution - 0477

Bunkyo-ku, Tokyo, 1138603, Japan

Location

Local Institution - 0505

Chuo-Ku, Tokyo, 104-0044, Japan

Location

Local Institution - 0224

Itabashi-Ku, Tokyo, 173-0003, Japan

Location

Local Institution - 0466

Koto-Ku, Tokyo, 135-0061, Japan

Location

Local Institution - 0314

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Local Institution - 0475

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Local Institution - 0521

Fukuoka, 810-0001, Japan

Location

Local Institution - 0442

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Local Institution - 0434

Maastricht, Limburg, 6229 HX, Netherlands

Location

Local Institution - 0197

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

Location

Local Institution - 0213

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Local Institution - 0061

Utrecht, 3584 CX, Netherlands

Location

Local Institution - 0443

Lørenskog, 1478, Norway

Location

Local Institution - 0441

Oslo, 0424, Norway

Location

Local Institution - 0473

Trondheim, 7030, Norway

Location

Local Institution - 0042

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

Local Institution - 0038

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

Local Institution - 0091

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

Location

Local Institution - 0338

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Local Institution - 0203

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Local Institution - 0072

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Local Institution - 0017

Katowice, Silesian Voivodeship, 40-555, Poland

Location

Local Institution - 0415

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Local Institution - 0030

Bialystok, 15-276, Poland

Location

Local Institution - 0416

Lódz, 93-338, Poland

Location

Local Institution - 0059

Lodz, Łódź Voivodeship, 91-347, Poland

Location

Local Institution - 0044

Guimarães, Braga District, 4835-044, Portugal

Location

Local Institution - 0015

Almada, 2805-267, Portugal

Location

Local Institution - 0433

Leiria, 2410-197, Portugal

Location

Local Institution - 0023

Lisbon, 1500-650, Portugal

Location

Local Institution - 0024

Lisbon, 1649-035, Portugal

Location

Local Institution - 0014

Vila Nova de Gaia, 4434-502, Portugal

Location

Local Institution - 0516

Daegu, Daegu Gwang'yeogsi, 42601, South Korea

Location

Local Institution - 0518

Incheon, Incheon Gwang'yeogsi, 22332, South Korea

Location

Local Institution - 0012

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Local Institution - 0055

Seoul, Seoul Teugbyeolsi, 6351, South Korea

Location

Local Institution - 0460

Seoul, Seoul Teugbyeolsi, 6591, South Korea

Location

Local Institution - 0517

Busan, 49241, South Korea

Location

Local Institution - 0508

Seongnam-si, 0, South Korea

Location

Local Institution - 0217

Seoul, 03080, South Korea

Location

Local Institution - 0049

Seoul, 05505, South Korea

Location

Local Institution - 0040

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Local Institution - 0299

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Local Institution - 0021

Majadahonda, Madrid, 28222, Spain

Location

Local Institution - 0237

El Palmar, Murcia, 30120, Spain

Location

Local Institution - 0043

A Coruña, 15006, Spain

Location

Local Institution - 0087

Alicante, 03010, Spain

Location

Local Institution - 0018

Barcelona, 08035, Spain

Location

Local Institution - 0056

Barcelona, 08036, Spain

Location

Local Institution - 0060

Granada, 18014, Spain

Location

Local Institution - 0421

Madrid, 28034, Spain

Location

Local Institution - 0041

Málaga, 29010, Spain

Location

Local Institution - 0031

Salamanca, 37007, Spain

Location

Local Institution - 0051

Seville, 41009, Spain

Location

Local Institution - 0027

Valencia, 46026, Spain

Location

Local Institution - 0445

London, Greater London, SW3 6NP, United Kingdom

Location

Local Institution - 0073

Glasgow, Lanarkshire, G51 4TF, United Kingdom

Location

Local Institution - 0407

Birmingham, B15 2TH, United Kingdom

Location

Local Institution - 0472

London, EC1A 7BE, United Kingdom

Location

Related Publications (4)

• Desai MY, Owens AT, Abraham T, Olivotto I, Garcia-Pavia P, Lopes RD, Elliott P, Fernandes F, Verheyen N, Maier L, Meder B, Azevedo O, Kitaoka H, Wolski K, Wang Q, Jaber W, Mitchell L, Myers J, Rano T, Gong Z, Zhong Y, Carter-Bonanza S, Florea V, Aronson R, Nissen SE; ODYSSEY-HCM Investigators. Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy. N Engl J Med. 2025 Sep 11;393(10):961-972. doi: 10.1056/NEJMoa2505927. Epub 2025 Aug 30.

  PMID: 40888717 DERIVED

• Desai MY, Olivotto I, Abraham T, Nissen SE, Garcia-Pavia P, Lopes RD, Elliott PM, Fernandes F, de Barros Correia E, Barriales-Villa R, Zorio E, Arad M, Shin SH, Verheyen N, Meder B, Azevedo O, Kitaoka H, Wolski K, Wang Q, Suryawanshi B, Wang Z, Florea V, Aronson R, Owens AT; ODYSSEY-HCM Investigators. Effects of Mavacamten on Cardiac Biomarkers in Nonobstructive Hypertrophic Cardiomyopathy: Insights From the ODYSSEY-HCM Trial. J Am Coll Cardiol. 2025 Dec 16;86(24):2418-2433. doi: 10.1016/j.jacc.2025.08.017. Epub 2025 Aug 27.

  PMID: 40864018 DERIVED

• Desai MY, Nissen SE, Abraham T, Olivotto I, Garcia-Pavia P, Lopes RD, Verheyen N, Wever-Pinzon O, Wolski K, Jaber W, Mitchell L, Davey D, Myers J, Rano T, Bhatia V, Zhong Y, Carter-Bonanza S, Florea V, Aronson R, Owens AT; ODYSSEY-HCM Investigators. Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Design, Rationale, and Baseline Characteristics of ODYSSEY-HCM. JACC Heart Fail. 2025 Feb;13(2):358-370. doi: 10.1016/j.jchf.2024.11.013.

  PMID: 39909647 DERIVED

• O'Malley PA. Mavacamten (CAMZYOS) First-in-Class Small-Molecule Myosin Inhibitor for Treatment of Obstructive Hypertrophic Cardiomyopathy. Clin Nurse Spec. 2024 May-Jun 01;38(3):119-121. doi: 10.1097/NUR.0000000000000821. No abstract available.

  PMID: 38625800 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: October 17, 2022
• Study Start: December 14, 2022
• Primary Completion: March 6, 2025
• Study Completion: October 20, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

NO (3); ES (14); GB (4); PL (11); CZ (4); IN (5); CN (23); IL (9); US (41); DE (18); JP (18); BE (4); CA (5); AU (5); NL (5); IT (3); PT (6); DK (3); FR (11); HU (5); KR (9); BR (11)