Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

Last updated: February 9, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

2

Condition

Ulcers

Colic

Crohn's Disease

Treatment

Placebo

BMS-986165

Clinical Study ID

NCT03934216
IM011-024
2018-004694-27
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Eligibility Criteria

Inclusion

For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit www.BMSStudyConnect.com Inclusion Criteria:

  • Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge andconfirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomizationvisit
  • Must have documented diagnosis of UC of at least 3 months' duration prior to screening
  • Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectalbleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

Exclusion

Exclusion Criteria:

  • Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis,or pseudomembranous colitis (other than associated with Clostridium difficile [C.difficile])
  • Stool positive for C. difficile toxin at screening visit
  • Current or recent (within 12 weeks prior to the randomization visit) evidence offulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 131
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 01, 2019
Estimated Completion Date:
April 04, 2023

Connect with a study center

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Local Institution - 0071

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Local Institution

    Ballarat, Victoria 3350
    Australia

    Site Not Available

  • Local Institution - 0108

    Melbourne, Victoria 3181
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Local Institution - 0039

    Antwerpen, 2018
    Belgium

    Site Not Available

  • Local Institution - 0065

    Brussels, 1000
    Belgium

    Site Not Available

  • Clinique du MontLegia - CHC

    Liege, 4000
    Belgium

    Site Not Available

  • Local Institution

    New Westminister, British Columbia V3L 3W5
    Canada

    Site Not Available

  • Local Institution

    Etobicoke, Ontario M9V 4B8
    Canada

    Site Not Available

  • Hepato-Gastroenterology HK

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • Nemocnice Slany

    Slany, 274 01
    Czechia

    Site Not Available

  • Local Institution

    Clichy Cedex, 92110
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier cedex 5, 34295
    France

    Site Not Available

  • Local Institution

    Pierre Benite, 69495
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre Benite Cedex, 69495
    France

    Site Not Available

  • Local Institution

    Rennes Cedex 9, 35033
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord

    Saint-Etienne, 42055
    France

    Site Not Available

  • Local Institution

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Local Institution

    Jena, 07747
    Germany

    Site Not Available

  • Local Institution - 0070

    Kiel, 24105
    Germany

    Site Not Available

  • Local Institution - 0062

    Leipzig, 04103
    Germany

    Site Not Available

  • Local Institution

    Munchen, 81377
    Germany

    Site Not Available

  • Universitatsklinik Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Local Institution - 0024

    Budapest, 1097
    Hungary

    Site Not Available

  • Local Institution - 0042

    Budapest, 1088
    Hungary

    Site Not Available

  • Magyar Honvedseg-Egeszsegugyi Kozpont

    Budapest, 1062
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Bugat Pal Korhaz

    Gy?gy?, 3200
    Hungary

    Site Not Available

  • Bugat Pal Korhaz

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Local Institution - 0033

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi

    Bologna, 40126
    Italy

    Site Not Available

  • Local Institution - 0005

    Catanzaro, 88100
    Italy

    Site Not Available

  • Clinica Medica Azienda Ospedaliera Universitaria

    Messina, 98125
    Italy

    Site Not Available

  • Local Institution

    Milan, 20121
    Italy

    Site Not Available

  • Local Institution

    Milano, 20153
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution - 0027

    Pavia, 27100
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Local Institution - 0046

    Roma, 00133
    Italy

    Site Not Available

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128
    Italy

    Site Not Available

  • National Hospital Organization Hirosaki National Hospital

    Hirosaki, Aomori 036-8545
    Japan

    Site Not Available

  • Fukuoka University Chikushi Hospital

    Chikushino, Fukuoka 818-8502
    Japan

    Site Not Available

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka 818-8502
    Japan

    Site Not Available

  • Local Institution - 0078

    Kurume, Fukuoka 830-0011
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume-shi, Fukuoka 8300011
    Japan

    Site Not Available

  • National Hospital Organization Takasaki General Medical Center

    Takasaki, Gunma 3700829
    Japan

    Site Not Available

  • National Hospital Organization Takasaki General Medical Center

    Takasaki-Shi, Gunma 370-0829
    Japan

    Site Not Available

  • Hyogo College of Medicine Hospital

    Nishinomiya, Hyogo 663-8501
    Japan

    Site Not Available

  • Hyogo College of Medicine Hospital

    Nishinomiya-Shi, Hyogo 663-8501
    Japan

    Site Not Available

  • Local Institution - 0081

    Sagamihara-shi, Kanagawa 2520375
    Japan

    Site Not Available

  • Shiga University of Medical Science Hospital

    Otsu, Shiga 520-2192
    Japan

    Site Not Available

  • Local Institution - 0066

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Site Not Available

  • Local Institution - 0080

    Minato-ku, Tokyo 105-8471
    Japan

    Site Not Available

  • Local Institution - 0069

    Saga, 849-8501
    Japan

    Site Not Available

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Site Not Available

  • Local Institution

    Daegu, 700-712
    Korea, Republic of

    Site Not Available

  • Local Institution - 0064

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Local Institution

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • Local Institution

    Seoul, 156-755
    Korea, Republic of

    Site Not Available

  • Local Institution - 0013

    Bydgoszcz, 85-794
    Poland

    Site Not Available

  • Local Institution - 0091

    Bydgoszcz, 85-231
    Poland

    Site Not Available

  • Local Institution - 0045

    Lodz, 90-302
    Poland

    Site Not Available

  • Local Institution - 0100

    Lodz, 90-153
    Poland

    Site Not Available

  • Local Institution - 0098

    Nowy Targ, 34-400
    Poland

    Site Not Available

  • Local Institution

    Piotrk?ybunalski, 97-300
    Poland

    Site Not Available

  • Local Institution - 0094

    Piotrkow Trybunalski, 97-300
    Poland

    Site Not Available

  • Local Institution - 0040

    Sopot, 81-756
    Poland

    Site Not Available

  • Local Institution - 0053

    Szczecin, 71-434
    Poland

    Site Not Available

  • Local Institution - 0014

    Tychy, 43 100
    Poland

    Site Not Available

  • Centrum Zdrowia Matki Dziecka i Mlodziezy

    Warszawa, 00-635
    Poland

    Site Not Available

  • Local Institution - 0030

    Warszawa, 03-712
    Poland

    Site Not Available

  • Local Institution - 0088

    Warszawa, 00-728
    Poland

    Site Not Available

  • Local Institution - 0095

    Warszawa, 02-798
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz

    Warszawa, 03-580
    Poland

    Site Not Available

  • LexMedica

    Wroc?aw, 53-114
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw, 54-416
    Poland

    Site Not Available

  • Local Institution - 0037

    Wroclaw, 53-114
    Poland

    Site Not Available

  • Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko

    Nizhniy Novgorod, 603126
    Russian Federation

    Site Not Available

  • Local Institution - 0020

    Novosibirsk, 630005
    Russian Federation

    Site Not Available

  • Local Institution - 0092

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • Novosibirsk State Regional Clinical Hospital

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Local Institution - 0015

    Saratov, 410053
    Russian Federation

    Site Not Available

  • Multidisciplinary Consultative and Diagnostic Center

    Tyumen, 625026
    Russian Federation

    Site Not Available

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, S75 2EP
    United Kingdom

    Site Not Available

  • Local Institution - 0031

    Cambridge, CB2 2QQ
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust

    London, W2 1NY
    United Kingdom

    Site Not Available

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32611
    United States

    Site Not Available

  • Local Institution

    Jacksonville, Florida 32207-4958
    United States

    Site Not Available

  • Local Institution

    Miami, Florida 33144
    United States

    Site Not Available

  • Local Institution - 0048

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Local Institution - 0044

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Local Institution

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Local Institution - 0011

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Local Institution - 0121

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Local Institution - 0018

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Local Institution

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Local Institution - 0047

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Infusion Associates

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Local Institution - 0002

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • New York Langone Long Island Clinical Research Associates

    Great Neck, New York 11021
    United States

    Site Not Available

  • Local Institution - 0049

    Lake Success, New York 11042
    United States

    Site Not Available

  • New York University Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Consultants for Clinical Research

    Cincinnati, Ohio 45218
    United States

    Site Not Available

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Local Institution - 0074

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Rapid City Medical Center

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Local Institution - 0097

    Garland, Texas 75044
    United States

    Site Not Available

  • Local Institution - 0008

    Houston, Texas 77090
    United States

    Site Not Available

  • Gastroenterology Research of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Local Institution - 0106

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas 76092
    United States

    Site Not Available

  • Local Institution

    Spring, Texas 77386
    United States

    Site Not Available

  • Local Institution - 0116

    Tyler, Texas 75701
    United States

    Site Not Available

  • Local Institution - 0096

    Seattle, Washington 98101
    United States

    Site Not Available

  • Swedish First Hill Campus

    Seattle, Washington 98104
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Local Institution

    Spokane, Washington 99204
    United States

    Site Not Available

  • Local Institution - 0122

    Vancouver, Washington 98664
    United States

    Site Not Available

  • The Vancouver Clinic

    Vancouver, Washington 98664
    United States

    Site Not Available

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