Clinical trial NCT04877990: A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
Official title: An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Ulcerative Colitis
Keywords: BMS-986165
Crohn Colitis
Crohn Disease
Crohn Iliocolitis
Inflammatory Bowel Disease
Ulcerative Colitis
Deucravacitinib
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.


Eligibility criteria: Inclusion Criteria:

• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From first dose to 30 days post last dose (Up to 110 weeks)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From first dose to 30 days post last dose (Up to 110 weeks)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: From first dose to 30 days post last dose (Up to 110 weeks)
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: From first dose to 30 days post last dose (Up to 110 weeks)
measure: Change From Baseline in Laboratory Parameters
timeFrame: Baseline, Week 12, Week 108
measure: Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
timeFrame: Baseline, Week 48, Week 96
measure: Change From Baseline in Electrocardiogram (ECG) Parameters
timeFrame: Baseline, Week 48, Week 96
measure: Change From Baseline in Vital Signs Parameters - Heart Rate
timeFrame: Baseline, Week 12, Week 108
measure: Change From Baseline in Vital Signs Parameters
timeFrame: Baseline, Week 12, Week 108
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Local Institution - 0036
state: Louisiana
city: Wyoming
country: United States
facility: Local Institution - 0002
state: Michigan
city: Jackson
country: United States
facility: Local Institution - 0037
state: Mississippi
city: Cleveland
country: United States
facility: Local Institution - 0041
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution - 0038
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0066
state: South Carolina
city: Garland
country: United States
facility: Local Institution - 0053
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0056
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0049
state: Texas
city: Richmond
country: United States
facility: Local Institution - 0055
state: Virginia
city: Ballarat
country: Australia
facility: Local Institution - 0013
state: Victoria
city: Vaughan
country: Canada
facility: Local Institution - 0050
state: Ontario
city: Guangzhou
country: China
facility: Local Institution - 0030
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0029
state: Guangdong
city: Kiel
country: Germany
facility: Local Institution - 0012
city: Budapest
country: Hungary
facility: Local Institution - 0062
city: Budapest
country: Hungary
facility: Local Institution - 0023
city: Rozzano
country: Italy
facility: Humanitas
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Irccs - Policlinico San Matteo
city: Hirosaki
country: Japan
facility: Local Institution - 0063
state: Aomori
city: Sagamihara
country: Japan
facility: Local Institution - 0047
state: Kanagawa
city: Saga-shi
country: Japan
facility: Local Institution - 0027
state: Saga
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0026
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0044
state: Tokyo
city: Amsterdam
country: Netherlands
facility: Local Institution - 0060
state: Noord-Holland
city: Nowy Targ
country: Poland
facility: Local Institution - 0046
state: Małopolskie
city: Bydgoszcz
country: Poland
facility: Local Institution - 0022
city: Bydgoszcz
country: Poland
facility: Local Institution - 0003
city: Krakow
country: Poland
facility: Local Institution - 0001
city: Sopot
country: Poland
facility: Local Institution - 0028
city: Szczecin
country: Poland
facility: Local Institution - 0025
city: Warsaw
country: Poland
facility: Local Institution - 0035
city: Warsaw
country: Poland
facility: Local Institution - 0048
city: Warszawa
country: Poland
facility: Local Institution - 0004
city: Wroclaw
country: Poland
facility: Local Institution - 0018
city: Tychy
country: Poland
facility: Local Institution - 0061
state: Śląskie
city: Santa Maria da Feira
country: Portugal
facility: Local Institution - 0054
city: Bucharest
country: Romania
facility: Local Institution
city: Irkutsk
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Fuenlabrada
country: Spain
facility: Local Institution - 0045
state: Madrid
city: Taipei
country: Taiwan
facility: Local Institution - 0064
city: Morriston
country: United Kingdom
facility: Local Institution - 0034
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: