NCT06588855ClinicalTrials.gov

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

שלב 3דרושים 350 משתתפים200 אתרים30 מדינות

קטגוריות

גסטרואנטרולוגיה והפטולוגיה100%

רשום במרשם אחד

ClinicalTrials.govNCT06588855פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-09-19; recorded start 2024-12-11
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 534 other studies in this databaseCounted from the lead sponsor named in the record (Hoffmann-La Roche)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding13/20
Double-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 200 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 350 participants (target), run at 200 sites, across 30 countries.

How this score is built

Enrolment25/40
350 participants (target)
Site count25/25
200 sites
Country count15/15
30 countries
Planned duration10/10
Planned over about 75 months
Sponsor scale10/10
Hoffmann-La Roche has led 529 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

מצבים רפואיים

Moderately to Severely Active Ulcerative Colitis

זכאות

זכאות
מין	הכול
גילאים	16 Years – 80 Years
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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 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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	DOUBLE (2)
גיוס	דרושים 350 משתתפים

נותן חסות ושותפים

Hoffmann-La Roche נותן חסות

זרועות והתערבויות

AfimkibartEXPERIMENTAL
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
PlaceboPLACEBO_COMPARATOR
Participants will receive placebo IV followed by placebo SC.

התערבויות

תרופה Afimkibart
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
תרופה Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.

מדדי תוצאה

מדד תוצאה ראשוני
Percentage of Participants with Clinical Remission
Percentage of participants achieving Modified Mayo Score (mMS) \<=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
מסגרת זמן At Week 12
מדד תוצאה משני
Change in Partial Modified Mayo Score (pmMS)
Change in pmMS from baseline to Week 2. pmMS is a composite score of ulcerative colitis signs and symptoms activity given by the sum of the SFS and RBS. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed).
מסגרת זמן From baseline to Week 2
מדד תוצאה משני
Percentage of Participants with Endoscopic Improvement
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12.
מסגרת זמן At Week 12
מדד תוצאה משני
Percentage of Participants with Endoscopic Remission
Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.
מסגרת זמן At Week 12
מדד תוצאה משני
Percentage of Participants with Clinical Response
Percentage of participants achieving a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS \>= 1 or RBS = 0 or 1 (no blood seen or stool with streaks of blood) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). ES is measured on a scale from 0 (normal appearance of mucosa) to 3 (severe disease).
מסגרת זמן At Week 12
מדד תוצאה משני
Percentage of Participants with Histologic Improvement
Percentage of participants achieving a histologic improvement, defined as Geboes \<=3.1 at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
מסגרת זמן At Week 12
מדד תוצאה משני
Percentage of Participants with Histologic Remission
Percentage of participants achieving a histologic remission, defined as Geboes \<2B at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
מסגרת זמן At Week 12
מדד תוצאה משני
Participants with Histologic-Endoscopic Mucosal Improvement
Percentage of participants achieving Geboes \<= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
מסגרת זמן At Week 12
מדד תוצאה משני
Percentage of Participants with Histologic-Endoscopic Remission
Percentage of participants achieving Geboes \< 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
מסגרת זמן At Week 12
מדד תוצאה משני
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving mMS \<= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
מסגרת זמן At Week 12
מדד תוצאה משני
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups.
מסגרת זמן At Week 12
מדד תוצאה משני
Change in Bowel Urgency
Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).
מסגרת זמן Baseline through Week 12
מדד תוצאה משני
Change in Abdominal Pain
Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).
מסגרת זמן Baseline through Week 12
מדד תוצאה משני
Change in Fatigue
Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue.
מסגרת זמן Baseline to Week 12
מדד תוצאה משני
Change in Health-Related Quality of Life
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life.
מסגרת זמן Baseline to Week 12
מדד תוצאה משני
Overall Change in UC Symptoms
Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to"Much worse".
מסגרת זמן Baseline to Week 2 and Week 12
מדד תוצאה משני
Overall Severity in UC Symptoms
Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe".
מסגרת זמן Baseline to Week 2 and Week 12
מדד תוצאה משני
Incidence and Severity of Adverse Events (AEs)
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
מסגרת זמן Up to 30 Weeks after Baseline

תאריכים

תאריכים
תאריך התחלה	11 בדצמבר 2024 (בפועל)
סיום ראשוני	30 בינואר 2027 (משוער)
סיום	30 בינואר 2031 (משוער)
פורסם לראשונה	19 בספטמבר 2024 (בפועל)
עודכן לאחרונה	5 באוגוסט 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	אוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

162 אתרים מגייסים

Argentina

Argentina
מתקן	עיר	מדינה או אזור	מצב
Hospital Britanico	Ciudad Autonoma Bs As		מגייס
Instituto Medico CER	Quilmes		מגייס

Australia

Australia
מתקן	עיר	מדינה או אזור	מצב
Footscray Hospital	Footscray	Victoria	בוטל
Coral Sea Clinical Research Institute	Mackay	Queensland	בוטל
Macquarie University Hospital	Macquarie Park	New South Wales	פעיל, ללא גיוס
Royal Melbourne Hospital	Parkville	Victoria	פעיל, ללא גיוס

Austria

Austria
מתקן	עיר	מדינה או אזור	מצב
Ordensklinikum Linz Barmherzige Schwestern	Linz		פעיל, ללא גיוס
Klinikum Wels-Grieskirchen	Wels		בוטל

Belgium

Belgium
מתקן	עיר	מצב
AZORG Campus Aalst-Moorselbaan	Aalst	בוטל
CHU St Pierre (St Pierre)	Brussels	פעיל, ללא גיוס
Cliniques Universitaires St-Luc	Brussels	פעיל, ללא גיוס
AZ Oostende	Ostend	בוטל

Brazil

Brazil
מתקן	עיר	מדינה או אזור	מצב
Newdata Clinical Trials	Aracaju	Sergipe	מגייס
CECIP - Centro de Estudos Clínicos do Interior Paulista	Jaú	São Paulo	מגייס
Hospital Moinhos de Vento	Porto Alegre	Rio Grande do Sul	מגייס
Hospital Sírio-Libanês	São Paulo	São Paulo	בוטל
Centro Paulista de Investigacao Clinica - CEPIC	São Paulo	São Paulo	מגייס
Instituto Lobus Unimed Volta Redonda	Volta Redonda	Rio de Janeiro	מגייס

Bulgaria

Bulgaria
מתקן	עיר	מדינה או אזור	מצב
MC " Sveti Ivan Rilski Chudotvorets- 2010	Plovdiv		מגייס
"City Clinic UMHAC" EOOD	Sofia		מגייס
Second Multiprofile Hospital For Active Treatment-Sofia	Sofia Town	Sofia	בוטל

Canada

Canada
מתקן	עיר	מדינה או אזור	מצב
Barrie GI Associates	Barrie	Ontario	מגייס
GNRR Digestive Clinics and Research Center Inc.	Brampton	Ontario	בוטל
LDDI Clinical Trials Inc.	London	Ontario	מגייס
London Health Sciences Centre Uni Campus	London	Ontario	מגייס
CIUSSS-de-l?Est-de-l?Île-de-Montréal	Montreal	Quebec	מגייס
TIDHI Innovation Inc.	Toronto	Ontario	מגייס

Chile

Chile
מתקן	עיר	מדינה או אזור	מצב
Centro de Investigación Clínica UC-CICUC	Santiago		מגייס

China

China
מתקן	עיר	מדינה או אזור	מצב
Beijing No.6 Hospital	Beijing	Beijing Municipality	מגייס
Third Xiangya Hospital Centrel South University	Changsha		מגייס
West China Hospital of Sichuan University	Chengdu		מגייס
The second Affiliated Hospital of Guangzhou Medical University	Guangzhou		מגייס
Guangzhou First People's Hospital	Guangzhou		מגייס
Sir Run Run Shaw Hospital Zhejiang University	Hangzhou		מגייס
Huizhou Central People's Hospital	Huizhou		מגייס
The First Affilliated Hospital of Kunming Medical University	Kunming	Yunnan	מגייס
The Second Affiliated Hospital of Nanchang University	Nanchang		מגייס
The First Affiliate Hospital of Guangxi Medical University	Nanning		מגייס
The First Affiliated Hospital of Ningbo University	Ningbo		מגייס
The Affiliated Hospital of Medical College Qingdao University	Qingdao		מגייס
Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai		מגייס
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai		מגייס
Shengjing Hospital of China Medical University	Shenyang		מגייס
First Affiliated Hospital of Soochow University	Suzhou		מגייס
The First Affiliated Hospital of Xiamen University	Xiamen		פעיל, ללא גיוס
Zhongshan Hospital Xiamen University	Xiamen		מגייס

Croatia

Croatia
מתקן	עיר	מדינה או אזור	מצב
Borzan Polyclinic	Osijek		מגייס
Clinical Hospital Center Sestre Milosrdnice	Zagreb		בוטל

Czechia

Czechia
מתקן	עיר	מדינה או אזור	מצב
Hepato-Gastroenterologie HK, s.r.o.	Hradec Králové		מגייס
Fakultni nemocnice Ostrava	Ostrava - Poruba		בוטל

150 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06588855