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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06589986




Registration number
NCT06589986
Ethics application status
Date submitted
6/09/2024
Date registered
19/09/2024
Date last updated
6/01/2025

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2024-513014-35-00
Secondary ID [2] 0 0
GA45329
Universal Trial Number (UTN)
Trial acronym
Ametrine-1
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 at Week 12
Timepoint [1] 0 0
At Week 12
Primary outcome [2] 0 0
Percentage of Participants with Clinical Remission at Week 52
Timepoint [2] 0 0
At Week 52
Secondary outcome [1] 0 0
Change in Partial Modified Mayo Score (pmMS)
Timepoint [1] 0 0
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-Endoscopic Mucosal Improvement
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Percentage of Participants with Histologic-Endoscopic Remission
Timepoint [6] 0 0
At Week 12
Secondary outcome [7] 0 0
Percentage of Participants with Maintenance of Remission
Timepoint [7] 0 0
Week 12 and Week 52
Secondary outcome [8] 0 0
Percentage of Participants with Corticosteroid-Free Remission
Timepoint [8] 0 0
At Week 52
Secondary outcome [9] 0 0
Percentage of Participants with Endoscopic Improvement
Timepoint [9] 0 0
At Week 52
Secondary outcome [10] 0 0
Percentage of Participants with Endoscopic Remission
Timepoint [10] 0 0
At Week 52
Secondary outcome [11] 0 0
Percentage of Participants with Histologic-Endoscopic Mucosal Improvement
Timepoint [11] 0 0
At Week 52
Secondary outcome [12] 0 0
Percentage of Participants with Histologic-Endoscopic Remission
Timepoint [12] 0 0
At Week 52
Secondary outcome [13] 0 0
Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants
Timepoint [13] 0 0
At Week 12
Secondary outcome [14] 0 0
Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants
Timepoint [14] 0 0
At Week 52
Secondary outcome [15] 0 0
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Timepoint [15] 0 0
At Week 12
Secondary outcome [16] 0 0
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Timepoint [16] 0 0
At Week 52
Secondary outcome [17] 0 0
Change in Bowel Urgency
Timepoint [17] 0 0
Baseline through Week 52
Secondary outcome [18] 0 0
Change in Abdominal Pain
Timepoint [18] 0 0
Baseline through Week 52
Secondary outcome [19] 0 0
Change in Fatigue
Timepoint [19] 0 0
Baseline to Week 12 and Week 52
Secondary outcome [20] 0 0
Change in Health-Related Quality of Life
Timepoint [20] 0 0
Baseline to Week 12 and Week 52
Secondary outcome [21] 0 0
Overall Change in UC Symptoms
Timepoint [21] 0 0
Baseline to Week 2, Week 12, and Week 52
Secondary outcome [22] 0 0
Overall Severity in UC Symptoms
Timepoint [22] 0 0
Baseline to Week 2, Week 12, and Week 52
Secondary outcome [23] 0 0
Incidence and Severity of Adverse Events (AEs)
Timepoint [23] 0 0
Up to 70 Weeks after Baseline

Eligibility
Key inclusion criteria
* Confirmed diagnosis of UC
* Moderately to severely active UC assessed by mMS
* Bodyweight >= 40 kilogram (kg)
* 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
17/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2029
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
Belgium
State/province [23] 0 0
Bruxelles
Country [24] 0 0
Belgium
State/province [24] 0 0
Gent
Country [25] 0 0
Belgium
State/province [25] 0 0
Liege
Country [26] 0 0
Belgium
State/province [26] 0 0
Liège
Country [27] 0 0
Belgium
State/province [27] 0 0
Roeselare
Country [28] 0 0
Belgium
State/province [28] 0 0
Sint Niklaas
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Chile
State/province [30] 0 0
Santiago
Country [31] 0 0
China
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Changchun
Country [32] 0 0
China
State/province [32] 0 0
Chengdu
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China
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Guangzhou City
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China
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Shenzhen
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China
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Wuhan City
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Czechia
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Hradec Kralove
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Denmark
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Køge
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France
State/province [38] 0 0
Dijon
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France
State/province [39] 0 0
Pessac
Country [40] 0 0
France
State/province [40] 0 0
Pierre-Benite
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Hungary
State/province [42] 0 0
Budapest
Country [43] 0 0
Hungary
State/province [43] 0 0
Szekszard
Country [44] 0 0
Hungary
State/province [44] 0 0
Vác
Country [45] 0 0
Poland
State/province [45] 0 0
Bydgoszcz
Country [46] 0 0
Poland
State/province [46] 0 0
Rzeszów
Country [47] 0 0
Poland
State/province [47] 0 0
Wroc?aw
Country [48] 0 0
Poland
State/province [48] 0 0
Zamosc
Country [49] 0 0
Portugal
State/province [49] 0 0
Braga
Country [50] 0 0
Portugal
State/province [50] 0 0
Portimao
Country [51] 0 0
Portugal
State/province [51] 0 0
Porto
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Serbia
State/province [52] 0 0
Belgrade
Country [53] 0 0
Serbia
State/province [53] 0 0
Beograd
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Chugai Pharmaceutical
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Trial website
https://clinicaltrials.gov/study/NCT06589986
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: GA45329 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06589986