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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06588855




Registration number
NCT06588855
Ethics application status
Date submitted
6/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2024-513015-27-00
Secondary ID [2] 0 0
GA45330
Universal Trial Number (UTN)
Trial acronym
Ametrine-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderately to Severely Active Ulcerative Colitis 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 - RO7790121
Treatment: Drugs - Placebo

Experimental: RO7790121 - Participants will receive RO7790121 intravenously (IV) followed by RO7790121 subcutaneous (SC) injection.

Placebo comparator: Placebo - Participants will receive placebo IV followed by placebo SC.


Treatment: Drugs: RO7790121
RO7790121 will be administered as IV infusion. RO7790121 will be administered as SC injection.

Treatment: Drugs: Placebo
Placebo matching IV RO7790121. Placebo matching SC RO7790121.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Clinical Remission
Timepoint [1] 0 0
At Week 12
Secondary outcome [1] 0 0
Change in Partial Modified Mayo Score (pmMS)
Timepoint [1] 0 0
From baseline to Week 2
Secondary outcome [2] 0 0
Percentage of Participants with Endoscopic Improvement
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
Percentage of Participants with Endoscopic Remission
Timepoint [3] 0 0
At Week 12
Secondary outcome [4] 0 0
Percentage of Participants with Clinical Response
Timepoint [4] 0 0
At Week 12
Secondary outcome [5] 0 0
Percentage of Participants with Histologic Improvement
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Percentage of Participants with Histologic Remission
Timepoint [6] 0 0
At Week 12
Secondary outcome [7] 0 0
Participants with Histologic-Endoscopic Mucosal Improvement
Timepoint [7] 0 0
At Week 12
Secondary outcome [8] 0 0
Percentage of Participants with Histologic-Endoscopic Remission
Timepoint [8] 0 0
At Week 12
Secondary outcome [9] 0 0
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Timepoint [9] 0 0
At Week 12
Secondary outcome [10] 0 0
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Timepoint [10] 0 0
At Week 12
Secondary outcome [11] 0 0
Change in Bowel Urgency
Timepoint [11] 0 0
Baseline through Week 12
Secondary outcome [12] 0 0
Change in Abdominal Pain
Timepoint [12] 0 0
Baseline through Week 12
Secondary outcome [13] 0 0
Change in Fatigue
Timepoint [13] 0 0
Baseline to Week 12
Secondary outcome [14] 0 0
Change in Health-Related Quality of Life
Timepoint [14] 0 0
Baseline to Week 12
Secondary outcome [15] 0 0
Overall Change in UC Symptoms
Timepoint [15] 0 0
Baseline to Week 2 and Week 12
Secondary outcome [16] 0 0
Overall Severity in UC Symptoms
Timepoint [16] 0 0
Baseline to Week 2 and Week 12
Secondary outcome [17] 0 0
Incidence and Severity of Adverse Events (AEs)
Timepoint [17] 0 0
Up to 30 Weeks after Baseline

Eligibility
Key inclusion criteria
* Confirmed diagnosis of UC
* Moderately to severely active UC assessed by mMS
* Bodyweight >= 40 kilogram (kg)
* Up to date with colorectal cancer (CRC) screening performed according to local standards
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
* Presence of an ostomy or ileoanal pouch
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2029
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Coral Sea Clinical Research Institute - Mackay
Recruitment hospital [3] 0 0
Footscray Hospital - Footscray
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4740 - Mackay
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3050 - Parkville
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad Autonoma Bs As
Country [15] 0 0
Argentina
State/province [15] 0 0
Quilmes
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Austria
State/province [17] 0 0
Wels
Country [18] 0 0
Belgium
State/province [18] 0 0
Aalst
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussels
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Chile
State/province [22] 0 0
Santiago
Country [23] 0 0
China
State/province [23] 0 0
Changsha
Country [24] 0 0
China
State/province [24] 0 0
Chengdu City
Country [25] 0 0
China
State/province [25] 0 0
Guangzhou City
Country [26] 0 0
China
State/province [26] 0 0
Guangzhou
Country [27] 0 0
China
State/province [27] 0 0
Hangzhou City
Country [28] 0 0
China
State/province [28] 0 0
Huizhou
Country [29] 0 0
China
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Kunming
Country [30] 0 0
China
State/province [30] 0 0
Nanchang City
Country [31] 0 0
China
State/province [31] 0 0
Nanning
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China
State/province [32] 0 0
Ningbo City
Country [33] 0 0
China
State/province [33] 0 0
Qingdao
Country [34] 0 0
China
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Shanghai City
Country [35] 0 0
China
State/province [35] 0 0
Shanghai
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China
State/province [36] 0 0
ShenYang
Country [37] 0 0
China
State/province [37] 0 0
Suzhou
Country [38] 0 0
China
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Xiamen
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Czechia
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Ostrava - Poruba
Country [40] 0 0
Denmark
State/province [40] 0 0
Ålborg
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France
State/province [41] 0 0
Chambray les Tours
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France
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Clermont-Ferrand
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France
State/province [43] 0 0
Créteil
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France
State/province [44] 0 0
Nimes
Country [45] 0 0
France
State/province [45] 0 0
Vandoeuvre-les-nancy
Country [46] 0 0
Germany
State/province [46] 0 0
Heidelberg
Country [47] 0 0
Germany
State/province [47] 0 0
Lueneburg
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
Country [49] 0 0
Hungary
State/province [49] 0 0
Debrecen
Country [50] 0 0
Hungary
State/province [50] 0 0
Szombathely
Country [51] 0 0
Hungary
State/province [51] 0 0
Székesfehérvár
Country [52] 0 0
Italy
State/province [52] 0 0
Lazio
Country [53] 0 0
Mexico
State/province [53] 0 0
Veracruz
Country [54] 0 0
Netherlands
State/province [54] 0 0
Tilburg
Country [55] 0 0
Poland
State/province [55] 0 0
Bydgoszcz
Country [56] 0 0
Poland
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Knurów
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Poland
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Kraków
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Poland
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Lublin
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Poland
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Pozna?
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Poland
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Sopot
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Poland
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Szczecin
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Poland
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Warszawa
Country [63] 0 0
Poland
State/province [63] 0 0
Wroc?aw
Country [64] 0 0
Portugal
State/province [64] 0 0
Braga
Country [65] 0 0
Portugal
State/province [65] 0 0
Lisboa
Country [66] 0 0
Portugal
State/province [66] 0 0
Portimao
Country [67] 0 0
Portugal
State/province [67] 0 0
Porto
Country [68] 0 0
Portugal
State/province [68] 0 0
Santa Maria Da Feira
Country [69] 0 0
Portugal
State/province [69] 0 0
Viseu
Country [70] 0 0
Spain
State/province [70] 0 0
Madrid
Country [71] 0 0
Thailand
State/province [71] 0 0
Chiang Mai
Country [72] 0 0
Thailand
State/province [72] 0 0
Chonburi
Country [73] 0 0
Thailand
State/province [73] 0 0
Ubonratchathani
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Leicester
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Llanrhystud
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Stockport
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GA45330 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06588855