Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06049017




Registration number
NCT06049017
Ethics application status
Date submitted
15/09/2023
Date registered
21/09/2023
Date last updated
28/10/2024

Titles & IDs
Public title
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
77242113UCO2001
Secondary ID [2] 0 0
77242113UCO2001
Universal Trial Number (UTN)
Trial acronym
ANTHEM-UC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-77242113
Treatment: Drugs - Placebo

Experimental: Group 1: JNJ-77242113 Dose-1 - Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.

Experimental: Group 2: JNJ-77242113 Dose-2 - Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.

Experimental: Group 3: JNJ-77242113 Dose-3 - Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.

Experimental: Group 4: Placebo - Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.


Treatment: Drugs: JNJ-77242113
JNJ-77242113 tablet will be administered orally.

Treatment: Drugs: Placebo
Placebo tablet will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants with Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants with Symptomatic Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants with Endoscopic Improvement at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)
Timepoint [5] 0 0
Up to Week 76

Eligibility
Key inclusion criteria
* Signed informed consent form 18 years of age or older
* Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
* UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
* Presence of a stoma
* Presence or history of fistula
* History of extensive colonic resection (example, <30 cm of colon remaining)
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/01/2026
Actual
Sample size
Target
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Wollongong Private Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Ciudad Autonoma de Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Rosario
Country [22] 0 0
Argentina
State/province [22] 0 0
San Miguel de Tucuman
Country [23] 0 0
Belgium
State/province [23] 0 0
Brussels
Country [24] 0 0
Belgium
State/province [24] 0 0
Gent
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Liege
Country [27] 0 0
Belgium
State/province [27] 0 0
Sint Niklaas
Country [28] 0 0
Brazil
State/province [28] 0 0
Botucatu
Country [29] 0 0
Brazil
State/province [29] 0 0
Brasília
Country [30] 0 0
Brazil
State/province [30] 0 0
Curitiba
Country [31] 0 0
Brazil
State/province [31] 0 0
Porto Alegre
Country [32] 0 0
Brazil
State/province [32] 0 0
Santo Andre
Country [33] 0 0
Brazil
State/province [33] 0 0
Sao Paulo
Country [34] 0 0
Brazil
State/province [34] 0 0
Votuporanga
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
China
State/province [38] 0 0
Changsha
Country [39] 0 0
China
State/province [39] 0 0
Chongqing
Country [40] 0 0
China
State/province [40] 0 0
Guangzhou
Country [41] 0 0
China
State/province [41] 0 0
Hangzhou
Country [42] 0 0
China
State/province [42] 0 0
Jinan
Country [43] 0 0
China
State/province [43] 0 0
Lan Zhou
Country [44] 0 0
China
State/province [44] 0 0
Nan Jing Shi
Country [45] 0 0
China
State/province [45] 0 0
Shen Yang Shi
Country [46] 0 0
China
State/province [46] 0 0
Wuhan
Country [47] 0 0
China
State/province [47] 0 0
Wuxi
Country [48] 0 0
China
State/province [48] 0 0
Xi'An
Country [49] 0 0
Czechia
State/province [49] 0 0
Ceske Budejovice
Country [50] 0 0
Czechia
State/province [50] 0 0
Hradec Kralova
Country [51] 0 0
Czechia
State/province [51] 0 0
Hradec Kralove
Country [52] 0 0
Czechia
State/province [52] 0 0
Praha
Country [53] 0 0
Czechia
State/province [53] 0 0
Slany
Country [54] 0 0
France
State/province [54] 0 0
Besancon Cedex
Country [55] 0 0
France
State/province [55] 0 0
Creteil
Country [56] 0 0
France
State/province [56] 0 0
Lille
Country [57] 0 0
France
State/province [57] 0 0
Neuilly-sur-Seine
Country [58] 0 0
France
State/province [58] 0 0
Nice
Country [59] 0 0
France
State/province [59] 0 0
Nimes Cedex
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
France
State/province [61] 0 0
Pierre Benite
Country [62] 0 0
France
State/province [62] 0 0
Saint Priest en Jarez
Country [63] 0 0
France
State/province [63] 0 0
Toulouse
Country [64] 0 0
France
State/province [64] 0 0
Vandœuvre-les-Nancy
Country [65] 0 0
Germany
State/province [65] 0 0
Augsburg
Country [66] 0 0
Germany
State/province [66] 0 0
Berlin
Country [67] 0 0
Germany
State/province [67] 0 0
Dresden
Country [68] 0 0
Germany
State/province [68] 0 0
Hannover
Country [69] 0 0
Germany
State/province [69] 0 0
Kiel
Country [70] 0 0
Germany
State/province [70] 0 0
Leipzig
Country [71] 0 0
Germany
State/province [71] 0 0
Lueneburg
Country [72] 0 0
Germany
State/province [72] 0 0
Minden
Country [73] 0 0
Hungary
State/province [73] 0 0
Budapest
Country [74] 0 0
Hungary
State/province [74] 0 0
Debrecen
Country [75] 0 0
Hungary
State/province [75] 0 0
Gyongyos
Country [76] 0 0
India
State/province [76] 0 0
Jaipur
Country [77] 0 0
India
State/province [77] 0 0
Nagpur
Country [78] 0 0
India
State/province [78] 0 0
New Delhi
Country [79] 0 0
India
State/province [79] 0 0
Surat
Country [80] 0 0
Italy
State/province [80] 0 0
Milano
Country [81] 0 0
Italy
State/province [81] 0 0
Negrar Di Valpolicella
Country [82] 0 0
Italy
State/province [82] 0 0
Roma
Country [83] 0 0
Italy
State/province [83] 0 0
Rozzano
Country [84] 0 0
Italy
State/province [84] 0 0
San Giovanni Rotondo
Country [85] 0 0
Japan
State/province [85] 0 0
Fujiidera-shi
Country [86] 0 0
Japan
State/province [86] 0 0
Hamamatsu
Country [87] 0 0
Japan
State/province [87] 0 0
Kagoshima
Country [88] 0 0
Japan
State/province [88] 0 0
Kashiwa
Country [89] 0 0
Japan
State/province [89] 0 0
Kobe
Country [90] 0 0
Japan
State/province [90] 0 0
Osaka
Country [91] 0 0
Japan
State/province [91] 0 0
Sakura
Country [92] 0 0
Japan
State/province [92] 0 0
Sapporo
Country [93] 0 0
Japan
State/province [93] 0 0
Shimizu
Country [94] 0 0
Japan
State/province [94] 0 0
Sumida ku
Country [95] 0 0
Japan
State/province [95] 0 0
Tsu
Country [96] 0 0
Japan
State/province [96] 0 0
Yokohama
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Busan
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Daegu
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Seoul
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Suwon si
Country [101] 0 0
Malaysia
State/province [101] 0 0
Johor Bahru
Country [102] 0 0
Malaysia
State/province [102] 0 0
Kajang
Country [103] 0 0
Malaysia
State/province [103] 0 0
Kuala Lumpur
Country [104] 0 0
Poland
State/province [104] 0 0
Bydgoszcz
Country [105] 0 0
Poland
State/province [105] 0 0
Chojnice
Country [106] 0 0
Poland
State/province [106] 0 0
Krakow
Country [107] 0 0
Poland
State/province [107] 0 0
Rzeszow
Country [108] 0 0
Poland
State/province [108] 0 0
Szczecin
Country [109] 0 0
Poland
State/province [109] 0 0
Torun
Country [110] 0 0
Poland
State/province [110] 0 0
Warszawa
Country [111] 0 0
Poland
State/province [111] 0 0
Wroclaw
Country [112] 0 0
Romania
State/province [112] 0 0
Bucuresti
Country [113] 0 0
Romania
State/province [113] 0 0
Cluj-Napoca
Country [114] 0 0
Romania
State/province [114] 0 0
Ploiesti
Country [115] 0 0
Spain
State/province [115] 0 0
Alcorcon
Country [116] 0 0
Spain
State/province [116] 0 0
Ferrol
Country [117] 0 0
Spain
State/province [117] 0 0
Gijon
Country [118] 0 0
Spain
State/province [118] 0 0
Madrid
Country [119] 0 0
Spain
State/province [119] 0 0
Majadahonda
Country [120] 0 0
Spain
State/province [120] 0 0
Santiago de Compostela
Country [121] 0 0
Spain
State/province [121] 0 0
Sevilla
Country [122] 0 0
Spain
State/province [122] 0 0
Valencia
Country [123] 0 0
Spain
State/province [123] 0 0
Vigo
Country [124] 0 0
Turkey
State/province [124] 0 0
Ankara
Country [125] 0 0
Turkey
State/province [125] 0 0
Bursa
Country [126] 0 0
Turkey
State/province [126] 0 0
Izmir
Country [127] 0 0
Turkey
State/province [127] 0 0
Mersin
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Bury
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Cambridge
Country [130] 0 0
United Kingdom
State/province [130] 0 0
London
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Oxford
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Prescot
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
Trial website
https://clinicaltrials.gov/study/NCT06049017
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06049017