A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) (ESCALADE)

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL

Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

Study Overview

• Status: Active, not recruiting
• Conditions: Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Drug: acalabrutinib; Drug: Prednisone; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin; Drug: placebo

Detailed Description

Phase 3 randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as compared with placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma (activated B-cell (ABC) and unclassified).

• Study Type: Interventional
• Enrollment (Actual): 611
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Research Site
  • Camperdown, Australia, 2050
    • Research Site
  • Clayton, Australia, 3168
    • Research Site
  • Darlinghurst, Australia, 2010
    • Research Site
  • Heidelberg, Australia, 3084
    • Research Site
  • Hobart, Australia, 7000
    • Research Site
  • Kogarah, Australia, 2217
    • Research Site
  • Liverpool, Australia, 2170
    • Research Site
  • Nedlands, Australia, 6009
    • Research Site
  • Westmead, Australia, 2145
    • Research Site
• Austria
  • Linz, Austria, 4021
    • Research Site
  • Salzburg, Austria, 5020
    • Research Site
  • Wels, Austria, 4600
    • Research Site
• Belgium
  • Antwerpen, Belgium, 2060
    • Research Site
  • Brugge, Belgium, 8000
    • Research Site
  • La Louvière, Belgium, 7100
    • Research Site
• Brazil
  • Curitiba, Brazil, 81520-060
    • Research Site
  • Florianopolis, Brazil, 88034-000
    • Research Site
  • Goiania, Brazil, 74605-020
    • Research Site
  • Passo Fundo, Brazil, 99010-260
    • Research Site
  • Porto Alegre, Brazil, 90035-003
    • Research Site
  • Porto Alegre, Brazil, 90619-900
    • Research Site
  • Porto Alegre, Brazil, 90110-270
    • Research Site
  • Ribeirão Preto, Brazil, 14051-140
    • Research Site
  • Rio de Janeiro, Brazil, 22793-080
    • Research Site
  • Sao Paulo, Brazil, 01236-030
    • Research Site
  • Sao Paulo, Brazil, 01509-900
    • Research Site
  • Sao Paulo, Brazil, 05652-900
    • Research Site
  • Sao Paulo, Brazil, 04029-000
    • Research Site
  • Sao Paulo, Brazil, 5403
    • Research Site
  • Sao Paulo, Brazil, 13083-878
    • Research Site
  • São Paulo, Brazil, 08270-070
    • Research Site
  • São Paulo, Brazil, 01323-001
    • Research Site
• Canada
  • Ottawa, Canada, K1H 8L6
    • Research Site
  • Quebec, Canada, G1J 1Z4
    • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Research Site
  • CA
    • Toronto, CA, Canada, M5G 2M9
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Research Site
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Research Site
  • Quebec
    • Lévis, Quebec, Canada, G6V 0B8
      • Research Site
    • Montreal, Quebec, Canada, H2X 3E4
      • Research Site
    • Montreal, Quebec, Canada, H1T 2M4
      • Research Site
• China
  • Beijing, China, 100044
    • Research Site
  • Beijing, China, 100191
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Guangzhou, China, 510120
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Guangzhou, China, 510060
    • Research Site
  • Hangzhou, China, 310003
    • Research Site
  • Hangzhou, China, 310009
    • Research Site
  • Harbin, China, 150081
    • Research Site
  • Jinan, China, 250117
    • Research Site
  • Luoyang, China, 471003
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanning, China, 530021
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China
    • Research Site
  • Shenyang, China, 110042
    • Research Site
  • Shenyang, China, 110004
    • Research Site
  • Shijiazhuang, China, 050020
    • Research Site
  • Suzhou, China, 215006
    • Research Site
  • Tianjin, China, 300060
    • Research Site
  • Tianjin, China, 300020
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Wuhan, China, 430030
    • Research Site
  • Xiamen, China, 361003
    • Research Site
  • Zhengzhou, China, 450008
    • Research Site
• Czechia
  • Brno, Czechia, 625 00
    • Research Site
  • Hradec Kralove, Czechia, 500 05
    • Research Site
  • Ostrava - Poruba, Czechia, 708 52
    • Research Site
  • Plzen, Czechia, 304 60
    • Research Site
  • Praha 10, Czechia, 100 34
    • Research Site
  • Praha 2, Czechia, 12808
    • Research Site
• France
  • Brest, France, 29609
    • Research Site
  • Caen Cedex 9, France, 14033
    • Research Site
  • Marseille cedex 5, France, 13385
    • Research Site
  • Montpellier, France, 34295
    • Research Site
  • Nantes, France, 44093
    • Research Site
  • Pessac, France, 33604
    • Research Site
  • Pierre Benite, France, 69495
    • Research Site
  • Rennes Cedex 9, France, 35033
    • Research Site
  • Toulouse, France, 31100
    • Research Site
• Germany
  • Bamberg, Germany, 96049
    • Research Site
  • Berlin, Germany, 10967
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Homburg, Germany, 66421
    • Research Site
  • Neumünster, Germany, 24534
    • Research Site
• India
  • Bangalore, India, 560064
    • Research Site
  • Delhi, India, 110029
    • Research Site
  • Kochi, India, 682041
    • Research Site
  • Mumbai, India, 400 012
    • Research Site
  • Nashik, India, 422004
    • Research Site
  • Pune, India, 411001
    • Research Site
• Israel
  • Afula, Israel, 18101
    • Research Site
  • Ashdod, Israel, 7747629
    • Research Site
  • Beer Sheba, Israel, 8410101
    • Research Site
  • Haifa, Israel, 34362
    • Research Site
  • Haifa, Israel, 31096
    • Research Site
  • Haifa, Israel, 31048
    • Research Site
  • Holon, Israel, 58100
    • Research Site
  • Jerusalem, Israel, 91031
    • Research Site
  • Jerusalem, Israel, 91120
    • Research Site
  • Nahariya, Israel, 22100
    • Research Site
  • Petah Tikva, Israel, 4941492
    • Research Site
  • Ramat Gan, Israel, 52621
    • Research Site
  • Tel Aviv, Israel, 6423906
    • Research Site
  • Zerifin, Israel, 70300
    • Research Site
• Italy
  • Bari, Italy, 70124
    • Research Site
  • Bergamo, Italy, 24127
    • Research Site
  • Bologna, Italy, 40138
    • Research Site
  • Firenze, Italy, 50134
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Meldola, Italy, 47014
    • Research Site
  • Milan, Italy, 20141
    • Research Site
  • Milano, Italy, 20162
    • Research Site
  • Novara, Italy, 28100
    • Research Site
  • Palermo, Italy, 90146
    • Research Site
  • Pavia, Italy, 27100
    • Research Site
  • Pisa, Italy, 56126
    • Research Site
  • Ravenna, Italy, 48121
    • Research Site
  • Reggio Emilia, Italy, 42123
    • Research Site
  • Roma, Italy, 00152
    • Research Site
  • Roma, Italy, 00144
    • Research Site
  • Siena, Italy, 53100
    • Research Site
  • Torino, Italy, 10126
    • Research Site
  • Tricase, Italy, 73039
    • Research Site
  • Venezia, Italy, 30174
    • Research Site
• Japan
  • Chiba-shi, Japan, 260-8717
    • Research Site
  • Chuo-ku, Japan, 104-0045
    • Research Site
  • Fukuoka-shi, Japan, 812-8582
    • Research Site
  • Itabashi-ku, Japan, 173-8610
    • Research Site
  • Kahoku-gun, Japan, 920-0293
    • Research Site
  • Kashiwa, Japan, 277-8577
    • Research Site
  • Kobe-shi, Japan, 650-0047
    • Research Site
  • Koto-ku, Japan, 135-8550
    • Research Site
  • Kumamoto-shi, Japan, 860-0008
    • Research Site
  • Kumamoto-shi, Japan, 860-8556
    • Research Site
  • Kyoto-city, Japan, 602-8026
    • Research Site
  • Matsuyama-shi, Japan, 791-0280
    • Research Site
  • Nagasaki-shi, Japan, 852-8501
    • Research Site
  • Nagoya-shi, Japan, 464-8681
    • Research Site
  • Nagoya-shi, Japan, 466-8560
    • Research Site
  • Nagoya-shi, Japan, 460-0001
    • Research Site
  • Niigata-shi, Japan, 951-8520
    • Research Site
  • Okayama-shi, Japan, 700-8558
    • Research Site
  • Osaka-shi, Japan, 545-8586
    • Research Site
  • Sapporo-shi, Japan, 003-0006
    • Research Site
  • Sendai-shi, Japan, 980-8574
    • Research Site
  • Shimotsuke-shi, Japan, 329-0498
    • Research Site
  • Tsu-shi, Japan, 514-8507
    • Research Site
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Research Site
  • Busan, Korea, Republic of, 49201
    • Research Site
  • Goyang-si, Korea, Republic of, 10408
    • Research Site
  • Jeonju-si, Korea, Republic of, 54907
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 06591
    • Research Site
  • Seoul, Korea, Republic of, 5505
    • Research Site
  • Seoul, Korea, Republic of, 6351
    • Research Site
  • Suwon-si, Korea, Republic of, 16499
    • Research Site
• Mexico
  • Chihuahua, Mexico, 31000
    • Research Site
  • Monterrey, Mexico, 64460
    • Research Site
• Poland
  • Gdańsk, Poland, 80-952
    • Research Site
  • Kraków, Poland, 30-510
    • Research Site
  • Lublin, Poland, 20-081
    • Research Site
  • Warszawa, Poland, 02-776
    • Research Site
  • Wrocław, Poland, 50-367
    • Research Site
  • Łódź, Poland, 93-513
    • Research Site
• Portugal
  • Braga, Portugal, 4710
    • Research Site
  • Lisboa, Portugal, 1649-035
    • Research Site
  • Lisboa, Portugal, 1400-038
    • Research Site
  • Lisboa, Portugal, 1998-018
    • Research Site
  • Matosinhos, Portugal, 4454-509
    • Research Site
  • Porto, Portugal, 4099-001
    • Research Site
  • Porto, Portugal, 4200-319
    • Research Site
  • Vila Nova de Gaia, Portugal, 4434-502
    • Research Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • Research Site
  • Moscow, Russian Federation, 125284
    • Research Site
  • Saint Petersburg, Russian Federation, 194291
    • Research Site
  • St. Petersburg, Russian Federation, 197022
    • Research Site
• Spain
  • Alcalá De Henares, Spain, 28805
    • Research Site
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Gijón, Spain, 33394
    • Research Site
  • L'Hospitalet de Llobregat, Spain, 08908
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28007
    • Research Site
  • Madrid, Spain, 28033
    • Research Site
  • Palma, Spain, 07198
    • Research Site
  • Pamplona, Spain, 31008
    • Research Site
  • Pozuelo de Alarcón, Spain, 28223
    • Research Site
  • Salamanca, Spain, 37007
    • Research Site
  • Sevilla, Spain, 41013
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 833
    • Research Site
  • Tainan, Taiwan, 736
    • Research Site
  • Tainan, Taiwan, 70403
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
  • Taipei, Taiwan, 235
    • Research Site
  • Taipei 112, Taiwan
    • Research Site
  • Taoyuan City, Taiwan
    • Research Site
• Turkey
  • Ankara, Turkey, 6500
    • Research Site
  • Ankara, Turkey, 6200
    • Research Site
  • Ankara, Turkey, 06700
    • Research Site
  • Balcova, Turkey, 35340
    • Research Site
  • Edirne, Turkey, 22030
    • Research Site
  • Izmir, Turkey, 35040
    • Research Site
  • Kayseri, Turkey, 38030
    • Research Site
  • Mersin, Turkey, 33079
    • Research Site
  • Samsun, Turkey, 55139
    • Research Site
  • Trabzon, Turkey, 61080
    • Research Site
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Research Site
  • Khmelnytskyi, Ukraine, 29000
    • Research Site
  • Kyiv, Ukraine, 03022
    • Research Site
  • Kyiv, Ukraine, 04112
    • Research Site
  • Lviv, Ukraine, 79044
    • Research Site
  • Mykolayiv, Ukraine, 54058
    • Research Site
  • Zaporizhzhia, Ukraine, 69600
    • Research Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Site
  • California
    • Irvine, California, United States, 92618
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Research Site
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Research Site
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Research Site
    • Orlando, Florida, United States, 32804
      • Research Site
    • Saint Petersburg, Florida, United States, 33705-1449
      • Research Site
    • Tallahassee, Florida, United States, 32308-5304
      • Research Site
    • West Palm Beach, Florida, United States, 33401
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Research Site
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Research Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Research Site
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63129
      • Research Site
  • New York
    • Albany, New York, United States, 12208
      • Research Site
    • New York, New York, United States, 10065
      • Research Site
    • New York, New York, United States, 10028
      • Research Site
    • Stony Brook, New York, United States, 11795
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Research Site
    • Portland, Oregon, United States, 97239
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15212
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Research Site
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Research Site
    • Lubbock, Texas, United States, 79410
      • Research Site
  • Virginia
    • Salem, Virginia, United States, 24153
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women, age ≥18 and ≤75 years
• Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review.
• No prior treatment for DLBCL
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• International Prognostic Index (IPI) score of 1 to 5
• Disease Stage II to IV by the Ann Arbor Classification
• Adequate organ and marrow function
• Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab

Exclusion Criteria:

• Evidence of severe or uncontrolled systemic diseases
• Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)
• History of stroke or intracranial haemorrhage in preceding 6 months.
• Known CNS lymphoma or leptomeningeal disease
• Known primary mediastinal lymphoma
• Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
• Prior history of indolent lymphoma or CLL
• History of or ongoing confirmed PML
• Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
• Uncontrolled active systemic fungal, bacterial, viral, or other infection
• Prior anthracycline use ≥150 mg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acalabrutinib + R-CHOP; Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)	Drug: acalabrutinib; Investigational Product; Drug: Prednisone; Investigational Product; Drug: Rituximab; Investigational Product; Drug: Cyclophosphamide; Investigational Product; Drug: Vincristine; Investigational Product; Drug: Doxorubicin; Investigational Product
Placebo Comparator: placebo + R-CHOP; Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)	Drug: Prednisone; Investigational Product; Drug: Rituximab; Investigational Product; Drug: Cyclophosphamide; Investigational Product; Drug: Vincristine; Investigational Product; Drug: Doxorubicin; Investigational Product; Drug: placebo; Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B	at every single visit up to 60 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B	at every single visit up to 60 months
Overall survival in Arm A compared to Arm B	at every single visit up to 60 months
Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL	at every single visit up to 60 months

Collaborators and Investigators

• Sponsor: Acerta Pharma BV
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Neoplasms; Lymphoma; Rituximab; Lymphoma, Non-Hodgkin; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Lymphoma, B-Cell; Lymphoproliferative Disorders; Lymphatic Diseases; Acalabrutinib; Lymphoma, Large B-Cell, Diffuse; Calquence; Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Antibiotics, Antineoplastic; Tyrosine Kinase Inhibitors; Cyclophosphamide; Rituximab; Prednisone; Doxorubicin; Vincristine; Acalabrutinib
• Other Study ID Numbers: D8227C00001; 2019-001755-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No