A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

286

Participants

Timeline

Start Date

February 11, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

February 28, 2030

Conditions
Sickle Cell Disease
Interventions
DRUG

Mitapivat

Mitapivat tablets

OTHER

Mitapivat-matching placebo

Placebo to match 50 mg or 100 mg tablets

OTHER

Mitapivat-matching placebo

Placebo to match 100 mg tablets

Trial Locations (90)

1070

Hôpital Erasme, Anderlecht

1434

Nini Hospital, Tarablus

2030

ZAS Cadix, Antwerp

2650

Universitair Ziekenhuis Antwerpen, Edegem

4000

CHR de la Citadelle, Liège

Clinique CHC MontLégia, Liège

11472

King Khalid University Hospital, Riyadh

13005

Hopitaux de La Timone, Marseille

13100

Ziv Medical Center, Safed

16128

Ente Ospedaliero Ospedali Galliera, Genoa

18101

HaEmek Medical Center, Afula

20010

MedStar Washington Hospital Center, Washington D.C.

20814

National Heart Lung and Blood Institute, Bethesda

27834

East Carolina University - Brody School of Medicine, Greenville

31059

Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse

31096

Rambam Medical Center, Haifa

33000

Hôpital Pellegrin, CHU de Bordeaux, Bordeaux

33101

Sylvester Comprehensive Cancer Center-Miami, Miami

39232

Southern Specialty Clinic, Flowood

40100

Kemri Usamru, Kisumu

Kondele Children's Hospital, Kisumu

Victoria Biomedical Research Institute (VIBRI), Kisumu

41100

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

45147

Universitätsklinikum Essen, Essen

48201

Children's Hospital of Michigan, Detroit

75015

Hôpital Européen Georges Pompidou, Paris

77030

Texas Children's Hospital, Houston

80131

"A.O.R.N. A. Cardarelli", Napoli

80138

AOU dell'Università degli Studi della Campania Luigi Vanvitelli, Napoli

89106

Cure 4 The Kids Foundation, A Division of Roseman University of Health Sciences, Las Vegas

90146

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo

93053

Universitätsklinikum Regensburg, Regensburg

94000

CHU Hôpital Henri Mondor, Créteil

94609

Children's Hospital Oakland, Oakland

97139

CHU Guadeloupe, Pointe à Pitre

98195

Seattle Cancer Care Alliance, University of Washington, Seattle

101014

Lagos University Teaching Hospital, Surulere

900271

National Hospital Abuja, Abuja

University of Abuja Teaching Hospital, Abuja

92037-1337

University of California San Diego, La Jolla

90095-1678

UCLA Health, Los Angeles

06030-0001

University of Connecticut Health Center, Farmington

20010-2916

Children's National Hospital, Washington D.C.

60637-1443

University of Chicago Medical Center, Chicago

46202-5109

Riley Hospital For Children, Indianapolis

71103-4228

LSU Health Sciences Center - Shreveport, Shreveport

20774-5374

Kaiser Permanente - Largo Medical Center, Largo

02114-2621

Massachusetts General Hospital, Boston

02115-5724

Boston Children's Hospital, Boston

02118

Boston Medical Center & Boston University School of Medicine, Boston

48109-5000

University of Michigan, Ann Arbor

39110-6115

Mississippi Center for Advanced Medicine, Madison

19104-5127

Penn Medicine - University of Pennsylvania Health System, Philadelphia

19134-1011

St. Christopher's Hospital for Children, Philadelphia

02903

Lifespan at Rhode Island Hospital, Providence

77030-1501

University of Texas Health Science Center of Houston, Houston

23298-5058

Virginia Commonwealth University, Richmond

50070-460

Multihemo Servicos Medicos S/A, Recife

90035-903

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre

90619-900

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS), Porto Alegre

13083-878

Hospital de Clínicas da Unicamp, Campinas

14051-140

Hospital Das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto

Unknown

Praxis Pesquisa Medica, Santo André

Hacettepe University, Ankara

20211-030

HEMORIO Instituto Nacional de Hematologia, Rio de Janeiro

05403-010

Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo, São Paulo

L8N 3Z5

McMaster University - St. Joseph's Healthcare Hamilton, Hamilton

M5G2C4

University Health Network, Toronto

H2X 3E4

CHU Montreal, Montreal

H4A 3J1

McGill University Health Center, Montreal

00165

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN, Rome

00100

KEMRI CRDR Clinical Research Clinic Nairobi, Nairobi

00200

KEMRI/CRDR Siaya Clinical Research Annex, Nairobi

Strathmore University, Nairobi

42325- 00100

Gertrude's Children's Hospital, Nairobi

11-0236

American University of Beirut Medical Center, Beirut

4407-2020

American University of Beirut Medical Center, Beirut

H96G+247

Hammoud Hospital University Medical Center, Sidon

3015 GD

Erasmus MC, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

H5QC+36M

Sultan Qaboos University Hospital, Hematology Department, COM&HS, Muscat

1515 (KAIMRC)

King Abdullah International Medical Research Center, Riyadh

01130

Acibadem Adana Hospital, Seyhan

SE1 7EH

Evelina Children's Hospital, London

Guy's and St Thomas' NHS Foundation Trust, London

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

SE5 9RS

King's College Hospital NHS Foundation Trust, London

W12 0HS

Hammersmith Hospital, London

WC1E 6BT

University College London Hospitals (UCLH), London

M13 9WL

Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester

Sponsors
All Listed Sponsors
lead

Agios Pharmaceuticals, Inc.

INDUSTRY