Research Study Investigating How Well NDec Works in People With Sickle Cell Disease

Last updated: June 24, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

2

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Placebo

NDec - oral decitabine-tetrahydrouridine

HU - Hydroxyurea

Clinical Study ID

NCT05405114
NN7533-4470
2020-003485-39
U1111-1255-1324
  • Ages > 18
  • All Genders

Study Summary

This study examines how well a new, potential medicine called NDec works and is tolerated in people with sickle cell disease. NDec is a combination of two medicines (decitabine-tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease. Participants who are not taking Hydroxyurea (HU) will get NDec, NDec and placebo, or placebo. Participants who are on HU treatment before joining the study will get NDec, NDec and placebo, or continue on HU. Which treatment participants get is decided by chance. Participants getting NDec and/or Placebo will get capsules to take twice weekly. The study will last for about a year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age above or equal to 18 years at the time of signing informed consent

  • Confirmed diagnosis of SCD (including HbSS, HbSC, HbSβ0 thalassaemia and HbSβ+thalassaemia or other Sickle Cell disease variants)

  • 2-10 episodes of documented vaso-occlusive crisis (VOCs) within the last 12 monthsprior to the screening visit

  • Haemoglobin greater than or equal to 5.0 g/dL and below or equal to 10.5 g/dL atvisit 1

  • Absolute reticulocyte count above upper limit of the normal (ULN) at visit 1

  • Body weight 40 to 125 kg (inclusive).

Exclusion

Exclusion Criteria:

  • Patient is on chronic transfusion therapy as defined by receiving scheduled (pre-planned) series of blood transfusion (simple or exchange) for prophylacticpurposes, or the patient is likely to begin chronic transfusion therapy during thecourse of the trial, or has received RBC or whole blood transfusion for any reasonwithin 28 days of visit 1

  • Receipt of erythropoietin or other haematopoietic growth factor treatment within 28days of signing ICF, or planned treatment with these agents during the trial

  • Receipt of voxelotor, crizanlizumab or L-glutamine treatment within 12 weeks ofsigning the informed consent form, or planned treatment with such agents during thetrial

  • Platelet count greater than 800 x 10^9/L at visit 1

  • Absolute neutrophil count below or equal to 1.5 x 10^9/L at visit 1

  • Any condition/concurrent chronic disease involving the stomach or small intestinewhich may affect drug absorption, as per investigator's judgement

  • Female who is

  • pregnant, breast-feeding or intends to become pregnant within 6 months afterthe final trial product administration

  • child-bearing potential and not using highly effective methods of contraceptionand whose male partner is not using effective contraception, at screening anduntil 6 months after the last dose of trial product

  • Male with female partner of childbearing potential who does not agree to use condomand whose female partner of childbearing potential is not using a highly effectivecontraceptive measure from trial start to:

  • Six (6) months after the last dose of trial product for patients onNDec/Placebo

  • Six (6) months after the last dose of trial product for patients outside US andCA randomised to HU

  • Twelve (12) months after the last dose of trial product for patients randomisedto HU in US and CA

Study Design

Total Participants: 84
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 07, 2022
Estimated Completion Date:
August 27, 2025

Connect with a study center

  • LHSC - Victoria Hospital

    London, Ontario ON N6A 5W9
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    London, Ontario ON N6A 5W9
    Canada

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • Toronto General Hospital, Liver Clinic

    Toronto, Ontario M5G2C4
    Canada

    Site Not Available

  • McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-3

    Grenoble Cedex 9, 38043
    France

    Site Not Available

  • Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-3

    La Tronche, 38700
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    La Tronche, 38700
    France

    Active - Recruiting

  • Hospices Civils de Lyon-Hopital Edouard Herriot

    Lyon Cedex 03, 69437
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Lyon cedex 03, 69437
    France

    Active - Recruiting

  • Aghia Sophia Childrens' Hospital

    Goudi, 11527
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Goudi, 11527
    Greece

    Active - Recruiting

  • General Hospital Of Larissa Koutlibaneio And Triantafylleio

    Larissa, 41221
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Larissa, 41221
    Greece

    Site Not Available

  • Gen Univ Hospital of Patras, Thalassemia/Hemoglobinopathies

    Patra, 26504
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Patra, GR-26504
    Greece

    Active - Recruiting

  • All India Institute of Medical Sciences (AIIMS), Raipur

    Raipur, Chhattisgarh 492099
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Raipur, Chhattisgarh 492099
    India

    Site Not Available

  • BAPS Pramukh Swami Hospital

    Surat, Gujarat 395009
    India

    Site Not Available

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat 395002
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Surat, Gujarat 395002
    India

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Vadodara, Gujarat 390006
    India

    Site Not Available

  • SSG Hospital, Baroda

    Vadodara, Gujarat 390006
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka 560002
    India

    Site Not Available

  • Victoria Hospital (Bangalore Medical College and Research Institute)

    Bangalore, Karnataka 560002
    India

    Site Not Available

  • J.S.S.Hospital

    Mysore, Karnataka 570004
    India

    Site Not Available

  • Government Medical College, Kozhikode

    Kozhikode, Kerala 673008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kozhikode, Kerala 673008
    India

    Site Not Available

  • K.J Somaiya Hospital and Research Centre

    Mumbai, Maharashtra 400022
    India

    Site Not Available

  • Government Medical College and Hospital

    Nagpur, Maharashtra 440003
    India

    Site Not Available

  • Government Medical College and Super Speciality Hospital, Nagpur

    Nagpur, Maharashtra 440003
    India

    Site Not Available

  • IMS and SUM Hospital

    Bhubaneswar, Orissa 751003
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Bhubaneswar, Orissa 751003
    India

    Active - Recruiting

  • S.C.B. Medical College

    Cuttack, Orissa 753007
    India

    Site Not Available

  • Christian Medical College Hospital, Vellore

    Ranipet, Tamil Nadu 632517
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Ranipet, Tamil Nadu 632517
    India

    Site Not Available

  • Christian Medical College Hospital, Vellore

    Vellore, Tamil Nadu 632004
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Vellore, Tamil Nadu 632004
    India

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Hyderabad, Telengana 500082
    India

    Site Not Available

  • Yashoda hospital

    Hyderabad, Telengana 500082
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Lucknow, Uttar Pradesh 226014
    India

    Site Not Available

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh 226014
    India

    Site Not Available

  • NRS Medical College & Hospital

    Kolkata, West Bengal 700014
    India

    Site Not Available

  • NRS Medical College & Hospital

    Kolkatta, West Bengal 70014
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkatta, West Bengal 70014
    India

    Site Not Available

  • KIMS - Kingsway Hospital

    Nagpur, 440001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Nagpur, 440001
    India

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Genova, 16128
    Italy

    Site Not Available

  • Ospedali Galliera

    Genova, 16128
    Italy

    Site Not Available

  • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Milan, 20122
    Italy

    Site Not Available

  • Azienda Ospedale Universita Padova

    Padova, 35128
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Padova, 35128
    Italy

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Verona, 37134
    Italy

    Active - Recruiting

  • Policlinico GB Rossi

    Verona, 37134
    Italy

    Site Not Available

  • Hospital Nini

    Tripoli, 1434
    Lebanon

    Site Not Available

  • Novo Nordisk Investigational Site

    Tripoli, 1434
    Lebanon

    Site Not Available

  • Sultan Qaboos University Hospital

    Muscat, 123
    Oman

    Site Not Available

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Parktown, Johannesburg, Gauteng 2193
    South Africa

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Regional de Málaga

    Málaga, 29010
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Málaga, 29010
    Spain

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Zürich, 8091
    Switzerland

    Site Not Available

  • Acibadem Adana Hastanesi

    Adana, 01130
    Turkey

    Site Not Available

  • Cukurova Universitesi

    Adana, 01130
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Adana, 01130
    Turkey

    Active - Recruiting

  • Hacettepe University Hematology

    Ankara, 06230
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Ankara, 06230
    Turkey

    Site Not Available

  • Mersin University Medical Faculty Hospital, Hematology

    Mersin, 33110
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Mersin, 33110
    Turkey

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Central Middlesex Hospital

    London, NW10 7NS
    United Kingdom

    Site Not Available

  • Guy's Hosptial

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary_Manchester_0

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Mobile, Alabama 36617
    United States

    Site Not Available

  • University Of South Alabama

    Mobile, Alabama 36617
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oakland, California 94609
    United States

    Site Not Available

  • UCSF Oakland Benioff Children's Hospital

    Oakland, California 94609
    United States

    Site Not Available

  • Center for Inherited Blood Dis

    Orange, California 92868
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orange, California 92868
    United States

    Active - Recruiting

  • Harbor-UCLA Medical Center

    Torrance, California 90502-2004
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Torrance, California 90502-2004
    United States

    Active - Recruiting

  • Clinical and Transl Res Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Howard University

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Foundation for Sickle Cell Disease Research

    Hollywood, Florida 33023
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hollywood, Florida 33023
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Hospital & Clinics

    Miami, Florida 33136
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University Of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Metairie, Louisiana 70002
    United States

    Site Not Available

  • Tulane Sickle Cell Ctr- So LA

    Metairie, Louisiana 70002
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana 07112-2699
    United States

    Site Not Available

  • Mississippi Center Advanced Medicine

    Madison, Mississippi 39110
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Madison, Mississippi 39110
    United States

    Active - Recruiting

  • Cure 4 the Kids Foundation

    Las Vegas, Nevada 89135
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89135
    United States

    Site Not Available

  • Jacobi Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bronx, New York 10461
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New York, New York 10029
    United States

    Site Not Available

  • East Carolina University_Greenville_0

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Univ Oklahoma HSC_Okla City

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center_Oklahoma City

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19134
    United States

    Active - Recruiting

  • St Christopher Hosp for Child

    Philadelphia, Pennsylvania 19134
    United States

    Site Not Available

  • Medical Univ of SC Charleston

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Univ Texas HSC-Houston

    Houston, Texas 77030
    United States

    Site Not Available

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