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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934216
• Other study ID #: IM011-024
• Secondary ID: 2018-004694-27
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: April 4, 2023

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 4, 2023
• Est. primary completion date: June 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• BMS-986165
Specified Dose on Specified Days

Other:
• Placebo
Specified Dose on Specified Days

Locations

Country	Name	City	State
Australia	Local Institution - 0071	Bedford Park	South Australia
Australia	Local Institution - 0108	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	Local Institution - 0039	Antwerpen
Belgium	Local Institution - 0065	Brussels
Belgium	Clinique du MontLegia - CHC	Liege
Czechia	Hepato-Gastroenterology HK	Hradec Kralove
Czechia	Nemocnice Slany	Slany
France	Centre Hospitalier Universitaire de Montpellier	Montpellier cedex 5
France	Centre Hospitalier Lyon Sud	Pierre Benite Cedex
France	Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord	Saint-Etienne
France	Local Institution	Toulouse cedex 9
Germany	Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum	Berlin
Germany	Universitatsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Local Institution - 0070	Kiel
Germany	Local Institution - 0062	Leipzig
Germany	Universitatsklinik Ulm	Ulm
Hungary	Local Institution - 0024	Budapest
Hungary	Local Institution - 0042	Budapest
Hungary	Magyar Honvedseg-Egeszsegugyi Kozpont	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Bugat Pal Korhaz	Gyongyos
Italy	Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi	Bologna
Italy	Local Institution - 0005	Catanzaro
Italy	Clinica Medica Azienda Ospedaliera Universitaria	Messina
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Local Institution - 0027	Pavia
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma
Italy	Local Institution - 0046	Roma
Italy	Policlinico Universitario Campus Bio-Medico	Roma
Italy	Local Institution - 0033	Rozzano	Milano
Japan	Local Institution - 0066	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka
Japan	National Hospital Organization Hirosaki National Hospital	Hirosaki	Aomori
Japan	Local Institution - 0078	Kurume	Fukuoka
Japan	Local Institution - 0080	Minato-ku	Tokyo
Japan	Hyogo College of Medicine Hospital	Nishinomiya	Hyogo
Japan	Shiga University of Medical Science Hospital	Otsu	Shiga
Japan	Local Institution - 0069	Saga
Japan	Local Institution - 0081	Sagamihara-shi	Kanagawa
Japan	National Hospital Organization Takasaki General Medical Center	Takasaki	Gunma
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution - 0064	Daegu
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Poland	Local Institution - 0013	Bydgoszcz
Poland	Local Institution - 0091	Bydgoszcz
Poland	Local Institution - 0045	Lodz
Poland	Local Institution - 0100	Lodz
Poland	Local Institution - 0098	Nowy Targ
Poland	Local Institution - 0094	Piotrkow Trybunalski
Poland	Local Institution - 0040	Sopot
Poland	Local Institution - 0053	Szczecin
Poland	Local Institution - 0014	Tychy
Poland	Centrum Zdrowia Matki Dziecka i Mlodziezy	Warszawa
Poland	Local Institution - 0030	Warszawa
Poland	Local Institution - 0088	Warszawa
Poland	Local Institution - 0095	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz	Warszawa
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	Local Institution - 0037	Wroclaw
Russian Federation	Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko	Nizhniy Novgorod
Russian Federation	Local Institution - 0020	Novosibirsk
Russian Federation	Local Institution - 0092	Novosibirsk
Russian Federation	Novosibirsk State Regional Clinical Hospital	Novosibirsk
Russian Federation	Local Institution - 0015	Saratov
Russian Federation	Multidisciplinary Consultative and Diagnostic Center	Tyumen
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley
United Kingdom	Local Institution - 0031	Cambridge
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United States	Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge	Baton Rouge	Louisiana
United States	Connecticut Clinical Research Foundation	Bristol	Connecticut
United States	Local Institution - 0074	Charleston	South Carolina
United States	Local Institution - 0047	Chevy Chase	Maryland
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	University of Florida	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	Local Institution - 0097	Garland	Texas
United States	Gastro One	Germantown	Tennessee
United States	Local Institution - 0121	Glenview	Illinois
United States	Infusion Associates	Grand Rapids	Michigan
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Local Institution - 0008	Houston	Texas
United States	Local Institution - 0049	Lake Success	New York
United States	Local Institution - 0002	Las Vegas	Nevada
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Local Institution - 0048	New Port Richey	Florida
United States	New York University Langone Medical Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rapid City Medical Center	Rapid City	South Dakota
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	Local Institution - 0106	San Antonio	Texas
United States	Local Institution - 0096	Seattle	Washington
United States	Swedish First Hill Campus	Seattle	Washington
United States	Local Institution - 0018	Shreveport	Louisiana
United States	Texas Digestive Disease Consultants - Southlake	Southlake	Texas
United States	Local Institution - 0011	Suwanee	Georgia
United States	Local Institution - 0044	Sweetwater	Florida
United States	Local Institution - 0116	Tyler	Texas
United States	Local Institution - 0122	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting