Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03934216
Registration number
NCT03934216
Ethics application status
Date submitted
30/04/2019
Date registered
1/05/2019
Date last updated
6/03/2024
Titles & IDs
Public title
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2018-004694-27
Query!
Secondary ID [2]
0
0
IM011-024
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Other interventions - Placebo
Experimental: BMS-986165 -
Placebo comparator: Placebo -
Treatment: Drugs: BMS-986165
Specified Dose on Specified Days
Other interventions: Placebo
Specified Dose on Specified Days
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Clinical Remission Response Rate at Week 12
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
From first dose to 12 weeks.
Query!
Secondary outcome [1]
0
0
Clinical Response Rate at 12 Weeks
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
From first dose to 12 weeks
Query!
Secondary outcome [2]
0
0
Endoscopic Response at Week 12
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
up to 12 Weeks
Query!
Secondary outcome [3]
0
0
Histological Improvement Response Rate at 12 Weeks
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
up to 12 Weeks
Query!
Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
4/04/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
131
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [2]
0
0
Local Institution - 0071 - Bedford Park
Query!
Recruitment hospital [3]
0
0
Local Institution - 0108 - Melbourne
Query!
Recruitment hospital [4]
0
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [2]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [3]
0
0
3181 - Melbourne
Query!
Recruitment postcode(s) [4]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Connecticut
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Minnesota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nevada
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
South Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
South Dakota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Tennessee
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Washington
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Antwerpen
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Brussels
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Liege
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Hradec Kralove
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Slany
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Montpellier cedex 5
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Pierre Benite Cedex
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Saint-Etienne
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Toulouse cedex 9
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Berlin
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Dresden
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Hannover
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Kiel
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Leipzig
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Ulm
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Budapest
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Debrecen
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Gyongyos
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Milano
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Bologna
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Catanzaro
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Messina
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Padova
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Pavia
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Roma
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Aomori
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Fukuoka
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Gunma
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Hyogo
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Kanagawa
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Shiga
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Tokyo
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Saga
Query!
Country [51]
0
0
Korea, Republic of
Query!
State/province [51]
0
0
Daegu
Query!
Country [52]
0
0
Korea, Republic of
Query!
State/province [52]
0
0
Incheon
Query!
Country [53]
0
0
Korea, Republic of
Query!
State/province [53]
0
0
Seoul
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Bydgoszcz
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Lodz
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Nowy Targ
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Piotrkow Trybunalski
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Sopot
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Szczecin
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Tychy
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Warszawa
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Wroclaw
Query!
Country [63]
0
0
Russian Federation
Query!
State/province [63]
0
0
Nizhniy Novgorod
Query!
Country [64]
0
0
Russian Federation
Query!
State/province [64]
0
0
Novosibirsk
Query!
Country [65]
0
0
Russian Federation
Query!
State/province [65]
0
0
Saratov
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
Tyumen
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Barnsley
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Cambridge
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Glasgow
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
London
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT03934216
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/16/NCT03934216/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/16/NCT03934216/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03934216
Download to PDF