A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems.

The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks).

During the study, participants will visit their study clinic several times.

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: TAK-279; Drug: Placebo

Detailed Description

Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period.

An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -

1. TAK-279 Dose 1
2. TAK-279 Dose 2
3. Placebo

The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

• Study Type: Interventional
• Enrollment (Estimated): 207
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Murdoch, Australia, 6150
    • Harry Perkins Medical Research Institute Fiona Stanley Hospital
  • New South Wales
    • Sydney, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Cancer Care Centre-Mater Health Services
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
    • Woodville, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, 3011
      • Western Health/Footscray Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital Lung Institute Of Western Australia
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• Belgium
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven
  • Anderlecht / Region Capitale de Bruxelles/ Brussel
    • Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, Belgium, 1070
      • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • UMBAL Kaspela
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital
  • Sofia, Bulgaria, 1431
    • Diagnostic-Consultative Center Aleksandrovska Eood
  • Sofia, Bulgaria, 1000
    • Pecs University Clinical Center Mohacs Hospital
  • Sofia, Bulgaria, 1527
    • University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
  • Sofia, Bulgaria, 1784
    • University Hospital City Clinic Cancer Center
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Heritage Medical Research Clinic - University Of Calgary
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Hospital
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre - Victoria Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Université de Montréal
    • Montreal, Quebec, Canada, H3G 1A4
      • The Research Institute of the McGill University Health Center
• China
  • Hangzhou, China, 310016
    • Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
  • Shanghai, China, 201318
    • Shanghai Pudong New District Zhoupu Hospital
  • Chongqing Sheng
    • Chongqing, Chongqing Sheng, China, 401147
      • Chongqing General Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 3011
      • Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
  • Hubei
    • Chongqing, Hubei, China, 430060
      • Wuhan University - Renmin Hospital (Hubei General Hospital)
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital Of Central South University
  • Jiangsu
    • Changzhou, Jiangsu, China, 200001
      • The Second People's Hospital of Changzhou
  • Liaoning
    • Shenyang, Liaoning, China, 110022
      • China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Renji Hospital Shanghai Jiao Tong University School of Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
• Czechia
  • Brno, Czechia, 636 00
    • Vojenska nemocnice Brno
  • Brno, Czechia, 639 00
    • University Hospital Brno
  • Brno, Czechia, 602 00
    • SurGal Clinic SRO
  • Hradec Králové, Czechia, 50012
    • Hepato-Gastroenterologie HK, s.r.o.
  • Ostrava, Czechia, 71000
    • EndoArt
  • Ostrava-Poruba, Czechia, 708 00
    • Fakultni Nemocnice Ostrava (FNO)
  • Pardubice, Czechia, 530 03
    • Gastromedic s.r.o
  • Prague, Czechia, 15000
    • Axon Clinical s.r.o.
  • Prague, Czechia, 10100
    • Endohope Clinic
  • Ústí nad Labem, Czechia, 40113
    • Masaryk Hospital
  • Central Bohemia
    • Hořovice, Central Bohemia, Czechia, 268 31
      • NH Hospital
• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg Hospital
  • Esbjerg, Denmark, 6700
    • Sydvestjysk Region/Esbjerg Hospital
  • Hillerød, Denmark, 3400
    • Hillerod Hospital, Hilleroed Sygehus
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
  • Køge, Denmark, 4600
    • Region Sjaelland Sygehus Nord, Koge Sygehus
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Odense Universitetshospital (OUH) (Odense University Hospital)
• France
  • Clermont-Ferrand, France, 63000
    • CHU De Clermont Ferrand - Hopital Estaing
  • Nice, France, 6202
    • Hopital L'Archet 2
  • Saint-Etienne, France, 42055
    • Hopital Nord Chu Saint-Etienne
  • Vandœuvre-lès-Nancy, France, 54500
    • Centre Hospitalier Regional Universitaire de Nancy Hopital Brabois
• Germany
  • Frankfurt am Main, Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Hamburg, Germany, 20251
    • Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)
  • Heidelberg, Germany, 69115
    • Praxis fur Gastroenterologie
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
  • Ludwigshafen, Germany, 67065
    • St. Marien- und St. Annastiftskrankenhaus
  • Tübingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
  • Ulm, Germany, 89081
    • University Hospital Of Ulm, Universitatsklinikum Ulm
• Greece
  • Athens, Greece, 11527
    • Sotiria General Hospital of Athens
  • Athens, Greece, 15669
    • G.N.A. Gennimatas
  • Achaia
    • Pátrai, Achaia, Greece, 26504
      • University General Hospital of Patras
  • Attica
    • Athens, Attica, Greece, 106 76
      • Evaggelismos Hospital (Evangelismos Hospital)-University of Athens
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University Hospital of Heraklion
• Hungary
  • Budapest, Hungary, 1136
    • Pannonia Maganorvosi Centrum Kft.
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem
  • Budapest, Hungary, 1033
    • Clinexpert
  • Mohács, Hungary, 7700
    • Mohacsi Korhaz
  • Vác, Hungary, 2600
    • Jávorszky Ödön Kórház
• Israel
  • Ashdod, Israel, 7747629
    • Assuta Ashdod University Hospital
  • Beersheba, Israel, 84101
    • Soroka MC
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Ramat Gan, Israel, 5265601
    • The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
• Italy
  • Bologna, Italy, 40138
    • IRCCS A.O.U. Policlinico S. Orsola - Malpighi
  • Milan, Italy, 20132
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
  • Rome, Italy, 152
    • Azienda Ospedaliera San Camillo Forlanini
  • Rozzano, Italy, 20089
    • IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
• Japan
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Saga, Japan, 849-0937
    • Saga University Hospital
  • Chiba
    • Sakura, Chiba, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Sapporo Medical University Hospital
  • Osaka
    • Hirakata, Osaka, Japan, 5731191
      • Kansai Medical University Hospital
  • Tokyo
    • Minato, Tokyo, Japan, 105-8471
      • The Jikei University Hospital
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Mitaka, Tokyo, Japan, 181-8611
      • Kyorin University Hospital
• Norway
  • Oslo, Norway, 450
    • Oslo Univeristy Hospital Ulleval Hospital
  • Akershus
    • Lorenskog, Akershus, Norway, 1478
      • Akershus University Hospital
• Poland
  • Lodz, Poland, 90-153
    • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
  • Lublin, Poland, 20-582
    • Medrise sp. z o.o
  • Rzeszów, Poland, 35-326
    • Centrum Medyczne MedykSp. z o.o. Sp. K.
  • Rzeszów, Poland, 35302
    • Korczowski Bartosz, Gabinet Lekarski
  • Tychy, Poland, 43-100
    • H-T. Centrum Medyczne Sp. z o.o. Sp.k.
  • Warsaw, Poland, 04-501
    • WIP Warsaw IBD Point Profesor Kierkus
  • Dolnolskie
    • Wroclaw, Dolnolskie, Poland, 50-449
      • Centrum Medyczne Melita Medical
  • Kujawsko-pomo
    • Torun, Kujawsko-pomo, Poland, 87-100
      • Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
      • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
      • PlanetMed Sp. z o.o.
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-507
      • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
      • Twoja Przychodnia - Szczecinskie Centrum Medyczne
• Romania
  • Bucharest, Romania, 0 50159
    • Clinical Hospital Colentina-Spitalul Clinic Colentina
  • Bucharest, Romania, 13823
    • Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti
  • Bucharest, Romania, 14142
    • Delta Health Care
  • Bucharest, Romania, 20475
    • Spital Clinic Dr I Cantacuzino
  • Jud Timis
    • Timișoara, Jud Timis, Romania, 300002
      • Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
  • Sector 2
    • Bucharest, Sector 2, Romania, 021967
      • Monza-Ares Srl
• Slovakia
  • Banská Bystrica, Slovakia, 97401
    • Fakultna nemocnica F. D. Roosevelta
  • Bratislava, Slovakia, 811 09
    • Cliniq s. r. o.
  • Košice, Slovakia, 4013
    • Endomed
  • Nové Zámky, Slovakia, 94034
    • Fakultna nemocnica s poliklinikou Nove Zamky
  • Šahy, Slovakia, 936 01
    • Accout Center, s.r.o.- Gastroenterologicka ambulancia
• South Korea
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Seoul, South Korea, 6351
    • Samsung Medical Center
  • Seoul, South Korea, 3722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 5505
    • Asan Medical Center (AMC)
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 26426
      • Yonsei University Wonju Severance Christian Hospital
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Changhua County
    • Changhua, Changhua County, Taiwan, 50006
      • Changhua Christian Hospital (CCH)
  • Zhongzheng District
    • Taipei, Zhongzheng District, Taiwan, 100
      • National Taiwan University Hospital (NTUH)
• United Kingdom
  • Belfast, United Kingdom, BT16 1RH
    • South Eastern Health and Social Care Trust - The Ulster Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
  • E1 2at
    • London, E1 2at, United Kingdom, E1 2AT
      • Clinical Research Centre - Barts Health NHS Trust
• United States
  • California
    • Los Angeles, California, United States, 90067
      • GastroIntestinal BioSciences
    • Murrieta, California, United States, 92563
      • United Medical Doctors
  • Florida
    • Clearwater, Florida, United States, 33762
      • West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
    • Lakeland, Florida, United States, 33813
      • Auzmer Research
    • Naples, Florida, United States, 34102
      • GI PROS, Inc.
    • Tampa, Florida, United States, 33612
      • USF Health Morsani Center For Advanced Healthcare
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital, The Emory Clinic
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, P.C.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Woodholme Gastroenterology Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • University Gastroenterology
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Gastroenterology Associates, PA
  • Texas
    • Bellaire, Texas, United States, 77401
      • Novel Research, LLC
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days. In South Korea, the age requirement for adult participants is ≥19 years of age.
2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
4. Participants must meet the contraception recommendations.

Exclusion Criteria:

1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
4. Participants who have failed 3 or more classes of advanced therapies.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAK-279 Dose 1; TAK-279, capsules, orally at Dose 1 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.	Drug: TAK-279; TAK-279 capsules.; Other Names: Zasocitinib
Experimental: TAK-279 Dose 2; TAK-279, capsules, orally at Dose 2 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.	Drug: TAK-279; TAK-279 capsules.; Other Names: Zasocitinib
Placebo Comparator: Placebo; TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally either Dose 1 or Dose 2 up to Week 52 based on the response.	Drug: TAK-279; TAK-279 capsules.; Other Names: Zasocitinib; Drug: Placebo; TAK-279 placebo-matching capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)	The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of ≤2 with SF subscore ≤ 1, RB subscore = 0, and ES ≤ 1 (score of 1 modified to exclude friability).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)	Clinical response defined as reduction from baseline in mMS of ≥2 points and ≥30% from baseline and a decrease from baseline in the RB subscore of ≥1 point or an absolute RB subscore of ≤1 point at Week 12.	Baseline, Week 12
Percentage of Participants Achieving Symptomatic Remission at Week 12	Symptomatic remission is defined as a RB subscore of 0 and SF subscore of ≤1.	Week 12
Percentage of Participants Achieving Endoscopic Improvement at Week 12	Endoscopic improvement defined as a modified Mayo ES of ≤1 (score of 1 modified to exclude friability).	Week 12
Percentage of Participants Achieving Endoscopic Remission at Week 12	Endoscopic remission defined as a modified Mayo ES of 0.	Week 12
Percentage of Participants With no Bowel Urgency at Week 12	Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12.	Week 12
Percentage of Participants With no Abdominal Pain at Week 12	Abdominal pain measured by abdominal pain eDiary item at Week 12.	Week 12
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score ≥170 at Week 12	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.	Week 12
Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.	Baseline and Week 12
Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12	The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information about this study, click this link
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): August 4, 2027

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy; Latitude UC, Latitude Research Program
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: TAK-279-UC-2001; jRCT2031240228 (Registry Identifier: jRCT); 2023-506769-67-00 (Ctis: Abbreviated EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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