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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: BMS-986165; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Local Institution - 0071
  • Victoria
    • Melbourne, Victoria, Australia, 3181
      • Local Institution - 0108
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Belgium
  • Antwerpen, Belgium, 2018
    • Local Institution - 0039
  • Brussels, Belgium, 1000
    • Local Institution - 0065
  • Liege, Belgium, 4000
    • Clinique du MontLegia - CHC
• Czechia
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterology HK
  • Slany, Czechia, 274 01
    • Nemocnice Slaný
• France
  • Montpellier cedex 5, France, 34295
    • Centre Hospitalier Universitaire de Montpellier
  • Pierre Benite Cedex, France, 69495
    • Centre Hospitalier Lyon Sud
  • Saint-Etienne, France, 42055
    • Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord
  • Toulouse cedex 9, France, 31059
    • Local Institution
• Germany
  • Berlin, Germany, 13353
    • Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Kiel, Germany, 24105
    • Local Institution - 0070
  • Leipzig, Germany, 04103
    • Local Institution - 0062
  • Ulm, Germany, 89081
    • Universitätsklinik Ulm
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvédség-Egészségügyi Központ
  • Budapest, Hungary, 1088
    • Local Institution - 0042
  • Budapest, Hungary, 1097
    • Local Institution - 0024
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyongyos, Hungary, 3200
    • Bugat Pal Korhaz
• Italy
  • Bologna, Italy, 40126
    • Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
  • Catanzaro, Italy, 88100
    • Local Institution - 0005
  • Messina, Italy, 98125
    • Clinica Medica Azienda Ospedaliera Universitaria
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Pavia, Italy, 27100
    • Local Institution - 0027
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Bio-Medico
  • Roma, Italy, 00133
    • Local Institution - 0046
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Local Institution - 0033
• Japan
  • Saga, Japan, 849-8501
    • Local Institution - 0069
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8545
      • National Hospital Organization Hirosaki National Hospital
  • Fukuoka
    • Chikushino, Fukuoka, Japan, 818-8502
      • Fukuoka University Chikushi Hospital
    • Kurume, Fukuoka, Japan, 830-0011
      • Local Institution - 0078
  • Gunma
    • Takasaki, Gunma, Japan, 3700829
      • National Hospital Organization Takasaki General Medical Center
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 663-8501
      • Hyogo College of Medicine Hospital
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 2520375
      • Local Institution - 0081
  • Shiga
    • Otsu, Shiga, Japan, 520-2192
      • Shiga University Of Medical Science Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Local Institution - 0066
    • Minato-ku, Tokyo, Japan, 105-8471
      • Local Institution - 0080
• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Local Institution
  • Daegu, Korea, Republic of, 700-712
    • Local Institution
  • Daegu, Korea, Republic of, 42415
    • Local Institution - 0064
  • Incheon, Korea, Republic of, 22332
    • Local Institution
  • Seoul, Korea, Republic of, 137-701
    • Local Institution
  • Seoul, Korea, Republic of, 156-755
    • Local Institution
• Poland
  • Bydgoszcz, Poland, 85-794
    • Local Institution - 0013
  • Bydgoszcz, Poland, 85-231
    • Local Institution - 0091
  • Lodz, Poland, 90-153
    • Local Institution - 0100
  • Lodz, Poland, 90-302
    • Local Institution - 0045
  • Nowy Targ, Poland, 34-400
    • Local Institution - 0098
  • Piotrkow Trybunalski, Poland, 97-300
    • Local Institution - 0094
  • Sopot, Poland, 81-756
    • Local Institution - 0040
  • Szczecin, Poland, 71-434
    • Local Institution - 0053
  • Tychy, Poland, 43 100
    • Local Institution - 0014
  • Warszawa, Poland, 00-635
    • Centrum Zdrowia Matki Dziecka i Mlodziezy
  • Warszawa, Poland, 00-728
    • Local Institution - 0088
  • Warszawa, Poland, 02-798
    • Local Institution - 0095
  • Warszawa, Poland, 03-580
    • Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
  • Warszawa, Poland, 03-712
    • Local Institution - 0030
  • Wroclaw, Poland, 54-416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 53-114
    • Local Institution - 0037
• Russian Federation
  • Nizhniy Novgorod, Russian Federation, 603126
    • Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
  • Novosibirsk, Russian Federation, 630087
    • Novosibirsk State Regional Clinical Hospital
  • Novosibirsk, Russian Federation, 630005
    • Local Institution - 0020
  • Novosibirsk, Russian Federation, 630099
    • Local Institution - 0092
  • Saratov, Russian Federation, 410053
    • Local Institution - 0015
  • Tyumen, Russian Federation, 625026
    • Multidisciplinary Consultative and Diagnostic Center
• United Kingdom
  • Barnsley, United Kingdom, S75 2EP
    • Barnsley Hospital NHS Foundation Trust
  • Cambridge, United Kingdom, CB2 2QQ
    • Local Institution - 0031
  • Glasgow, United Kingdom, G51 4TF
    • NHS Greater Glasgow and Clyde
  • London, United Kingdom, W2 1NY
    • Imperial College Healthcare NHS Trust
  • Sheffield, United Kingdom, S10 2JF
    • Sheffield Teaching Hospitals NHS Foundation Trust
• United States
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Foundation
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Gainesville, Florida, United States, 32610-0316
      • University of Florida
    • New Port Richey, Florida, United States, 34653
      • Local Institution - 0048
    • Sweetwater, Florida, United States, 33172
      • Local Institution - 0044
  • Georgia
    • Suwanee, Georgia, United States, 30024
      • Local Institution - 0011
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Local Institution - 0121
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
    • Shreveport, Louisiana, United States, 71103
      • Local Institution - 0018
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Local Institution - 0047
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Infusion Associates
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Local Institution - 0002
  • New York
    • Lake Success, New York, United States, 11042
      • Local Institution - 0049
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45218
      • Consultants for Clinical Research
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Local Institution - 0074
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Garland, Texas, United States, 75044
      • Local Institution - 0097
    • Houston, Texas, United States, 77090
      • Local Institution - 0008
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of San Antonio
    • San Antonio, Texas, United States, 78229
      • Local Institution - 0106
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants - Southlake
    • Tyler, Texas, United States, 75701
      • Local Institution - 0116
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish First Hill Campus
    • Seattle, Washington, United States, 98101
      • Local Institution - 0096
    • Vancouver, Washington, United States, 98664
      • Local Institution - 0122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
• 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 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

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 of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation

Other protocol-defined inclusion/exclusion criteria apply

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
Placebo Comparator: Placebo	Other: Placebo; Specified Dose on Specified Days
Experimental: BMS-986165	Drug: BMS-986165; Specified Dose on Specified Days; Other Names: Deucravacitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Remission Response Rate at Week 12	Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1	From first dose to 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response Rate at 12 Weeks	Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1	From first dose to 12 weeks
Endoscopic Response at Week 12	Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern: Normal (score 0); patchy obliteration (score 1); Obliterated (score 2) Bleeding; None (score 0); Mucosal (score 1); Luminal mild (score 2); Luminal Moderate or severe (score 3) Erosions and Ulcers; None (score 0); Erosions ( score 1); Superficial Ulcer (2); Deep Ulcer (score 3) A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).	up to 12 Weeks
Histological Improvement Response Rate at 12 Weeks	Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1 Neutrophils <5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue. Achieving the following scores for the corresponding grades of the Geboes score: Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or < 5% crypts involved), and; Score of 0 for Grade 4 (crypt destruction: none), and; Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue) grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease	up to 12 Weeks

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 13, 2021
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Deucravacitinib
• Other Study ID Numbers: IM011-024; 2018-004694-27 (EudraCT Number)

Drug and device information, study documents

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