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

NCT03934216 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM011-0242018-004694-27
• Study Type: interventional
• Target: 131
• Locations: 13 countries
• Sites: 107

Brief 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).

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical Response Rate at 12 Weeks

  From first dose to 12 weeks

• Endoscopic Response at Week 12

  up to 12 Weeks

• Histological Improvement Response Rate at 12 Weeks

  up to 12 Weeks

Study Arms (2)

BMS-986165

EXPERIMENTAL

Drug: BMS-986165

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

BMS-986165 DRUG

Specified Dose on Specified Days

Also known as: Deucravacitinib

BMS-986165

Placebo OTHER

Specified Dose on Specified Days

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (107)

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010, United States

Location

University of Florida

Gainesville, Florida, 32610-0316, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Local Institution - 0048

New Port Richey, Florida, 34653, United States

Location

Local Institution - 0044

Sweetwater, Florida, 33172, United States

Location

Local Institution - 0011

Suwanee, Georgia, 30024, United States

Location

Local Institution - 0121

Glenview, Illinois, 60026, United States

Location

Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Local Institution - 0018

Shreveport, Louisiana, 71103, United States

Location

Local Institution - 0047

Chevy Chase, Maryland, 20815, United States

Location

Infusion Associates

Grand Rapids, Michigan, 49525, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0002

Las Vegas, Nevada, 89123, United States

Location

Local Institution - 0049

Lake Success, New York, 11042, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45218, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0074

Charleston, South Carolina, 29425, United States

Location

Rapid City Medical Center

Rapid City, South Dakota, 57701, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0097

Garland, Texas, 75044, United States

Location

Local Institution - 0008

Houston, Texas, 77090, United States

Location

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229, United States

Location

Local Institution - 0106

San Antonio, Texas, 78229, United States

Location

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, 76092, United States

Location

Local Institution - 0116

Tyler, Texas, 75701, United States

Location

Local Institution - 0096

Seattle, Washington, 98101, United States

Location

Swedish First Hill Campus

Seattle, Washington, 98104, United States

Location

Local Institution - 0122

Vancouver, Washington, 98664, United States

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution - 0071

Bedford Park, South Australia, 5042, Australia

Location

Local Institution - 0108

Melbourne, Victoria, 3181, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0039

Antwerp, 2018, Belgium

Location

Local Institution - 0065

Brussels, 1000, Belgium

Location

Clinique du MontLegia - CHC

Liège, 4000, Belgium

Location

Hepato-Gastroenterology HK

Hradec Králové, 500 12, Czechia

Location

Nemocnice Slany

Slaný, 274 01, Czechia

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord

Saint-Etienne, 42055, France

Location

Local Institution

Toulouse, 31059, France

Location

Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Local Institution - 0070

Kiel, 24105, Germany

Location

Local Institution - 0062

Leipzig, 04103, Germany

Location

Universitatsklinik Ulm

Ulm, 89081, Germany

Location

Magyar Honvedseg-Egeszsegugyi Kozpont

Budapest, 1062, Hungary

Location

Local Institution - 0042

Budapest, 1088, Hungary

Location

Local Institution - 0024

Budapest, 1097, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

Location

Local Institution - 0033

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi

Bologna, 40126, Italy

Location

Local Institution - 0005

Catanzaro, 88100, Italy

Location

Clinica Medica Azienda Ospedaliera Universitaria

Messina, 98125, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Local Institution - 0027

Pavia, 27100, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

Local Institution - 0046

Roma, 00133, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

National Hospital Organization Hirosaki National Hospital

Hirosaki, Aomori, 036-8545, Japan

Location

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Local Institution - 0078

Kurume, Fukuoka, 830-0011, Japan

Location

National Hospital Organization Takasaki General Medical Center

Takasaki, Gunma, 3700829, Japan

Location

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Local Institution - 0081

Sagamihara-shi, Kanagawa, 2520375, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

Location

Local Institution - 0066

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Local Institution - 0080

Minato-ku, Tokyo, 105-8471, Japan

Location

Local Institution - 0069

Saga, 849-8501, Japan

Location

Local Institution - 0091

Bydgoszcz, 85-231, Poland

Location

Local Institution - 0013

Bydgoszcz, 85-794, Poland

Location

Local Institution - 0100

Lodz, 90-153, Poland

Location

Local Institution - 0045

Lodz, 90-302, Poland

Location

Local Institution - 0098

Nowy Targ, 34-400, Poland

Location

Local Institution - 0094

Piotrkow Trybunalski, 97-300, Poland

Location

Local Institution - 0040

Sopot, 81-756, Poland

Location

Local Institution - 0053

Szczecin, 71-434, Poland

Location

Local Institution - 0014

Tychy, 43 100, Poland

Location

Centrum Zdrowia Matki Dziecka i Mlodziezy

Warsaw, 00-635, Poland

Location

Local Institution - 0088

Warsaw, 00-728, Poland

Location

Local Institution - 0095

Warsaw, 02-798, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz

Warsaw, 03-580, Poland

Location

Local Institution - 0030

Warsaw, 03-712, Poland

Location

Local Institution - 0037

Wroclaw, 53-114, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 54-416, Poland

Location

Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko

Nizhny Novgorod, 603126, Russia

Location

Local Institution - 0020

Novosibirsk, 630005, Russia

Location

Novosibirsk State Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

Local Institution - 0092

Novosibirsk, 630099, Russia

Location

Local Institution - 0015

Saratov, 410053, Russia

Location

Multidisciplinary Consultative and Diagnostic Center

Tyumen, 625026, Russia

Location

Local Institution - 0064

Daegu, 42415, South Korea

Location

Local Institution

Daegu, 700-712, South Korea

Location

Local Institution

Daegu, 700-721, South Korea

Location

Local Institution

Incheon, 22332, South Korea

Location

Local Institution

Seoul, 137-701, South Korea

Location

Local Institution

Seoul, 156-755, South Korea

Location

Barnsley Hospital NHS Foundation Trust

Barnsley, S75 2EP, United Kingdom

Location

Local Institution - 0031

Cambridge, CB2 2QQ, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, G51 4TF, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 1, 2019
• Study Start: July 1, 2019
• Primary Completion: June 13, 2021
• Study Completion: April 4, 2023
• Last Updated: March 6, 2024
• Results First Posted: July 6, 2022

Record last verified: 2024-02

Locations

RU (6); PL (16); JP (10); KR (6); GB (5); HU (5); US (31); BE (3); DE (6); CZ (2); IT (9); AU (4); FR (4)