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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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).

المرحلة 3مطلوب 350 مشاركاً200 موقع30 دولة

الفئات

أمراض الجهاز الهضمي والكبد100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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هل أنت مهتم بهذه الدراسة؟

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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.

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

ملخص

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).

الحالات

  • Moderately to Severely Active Ulcerative Colitis

الأهلية

الجنسالجميع
الأعمار16 Years – 80 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةDOUBLE (2)
التجنيدمطلوب 350 مشاركاً

الجهة الراعية والمتعاونون

  • Hoffmann-La Roche الجهة الراعية

الأذرع والتدخلات

  • AfimkibartEXPERIMENTAL

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

  • PlaceboPLACEBO_COMPARATOR

    Participants will receive placebo IV followed by placebo SC.

التدخلات

  • دواء Afimkibart

    Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.

  • دواء Placebo

    Placebo matching IV afimkibart. Placebo matching SC afimkibart.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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.

    الإطار الزمني At Week 12

  2. مقياس النتيجة الثانوي

    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).

    الإطار الزمني From baseline to Week 2

  3. مقياس النتيجة الثانوي

    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.

    الإطار الزمني At Week 12

  4. مقياس النتيجة الثانوي

    Percentage of Participants with Endoscopic Remission

    Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.

    الإطار الزمني At Week 12

  5. مقياس النتيجة الثانوي

    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).

    الإطار الزمني At Week 12

  6. مقياس النتيجة الثانوي

    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).

    الإطار الزمني At Week 12

  7. مقياس النتيجة الثانوي

    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).

    الإطار الزمني At Week 12

  8. مقياس النتيجة الثانوي

    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).

    الإطار الزمني At Week 12

  9. مقياس النتيجة الثانوي

    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).

    الإطار الزمني At Week 12

  10. مقياس النتيجة الثانوي

    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.

    الإطار الزمني At Week 12

  11. مقياس النتيجة الثانوي

    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.

    الإطار الزمني At Week 12

  12. مقياس النتيجة الثانوي

    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).

    الإطار الزمني Baseline through Week 12

  13. مقياس النتيجة الثانوي

    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).

    الإطار الزمني Baseline through Week 12

  14. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Baseline to Week 12

  15. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Baseline to Week 12

  16. مقياس النتيجة الثانوي

    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".

    الإطار الزمني Baseline to Week 2 and Week 12

  17. مقياس النتيجة الثانوي

    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".

    الإطار الزمني Baseline to Week 2 and Week 12

  18. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Up to 30 Weeks after Baseline

التواريخ

تاريخ البدء11 ديسمبر 2024 (فعلي)
الإتمام الأولي30 يناير 2027 (تقديري)
الإتمام30 يناير 2031 (تقديري)
أول نشر19 سبتمبر 2024 (فعلي)
آخر تحديث5 أغسطس 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأغسطس 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

162 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Hospital BritanicoCiudad Autonoma Bs Asقيد التجنيد
Instituto Medico CERQuilmesقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Footscray HospitalFootscrayVictoriaمسحوب
Coral Sea Clinical Research InstituteMackayQueenslandمسحوب
Macquarie University HospitalMacquarie ParkNew South Walesنشط، دون تجنيد
Royal Melbourne HospitalParkvilleVictoriaنشط، دون تجنيد

Austria

المنشأةالمدينةالولاية أو المنطقةالحالة
Ordensklinikum Linz Barmherzige SchwesternLinzنشط، دون تجنيد
Klinikum Wels-GrieskirchenWelsمسحوب

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
AZORG Campus Aalst-MoorselbaanAalstمسحوب
CHU St Pierre (St Pierre)Brusselsنشط، دون تجنيد
Cliniques Universitaires St-LucBrusselsنشط، دون تجنيد
AZ OostendeOstendمسحوب

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Newdata Clinical TrialsAracajuSergipeقيد التجنيد
CECIP - Centro de Estudos Clínicos do Interior PaulistaJaúSão Pauloقيد التجنيد
Hospital Moinhos de VentoPorto AlegreRio Grande do Sulقيد التجنيد
Hospital Sírio-LibanêsSão PauloSão Pauloمسحوب
Centro Paulista de Investigacao Clinica - CEPICSão PauloSão Pauloقيد التجنيد
Instituto Lobus Unimed Volta RedondaVolta RedondaRio de Janeiroقيد التجنيد

Bulgaria

المنشأةالمدينةالولاية أو المنطقةالحالة
MC " Sveti Ivan Rilski Chudotvorets- 2010Plovdivقيد التجنيد
"City Clinic UMHAC" EOODSofiaقيد التجنيد
Second Multiprofile Hospital For Active Treatment-SofiaSofia TownSofiaمسحوب

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Barrie GI AssociatesBarrieOntarioقيد التجنيد
GNRR Digestive Clinics and Research Center Inc.BramptonOntarioمسحوب
LDDI Clinical Trials Inc.LondonOntarioقيد التجنيد
London Health Sciences Centre Uni CampusLondonOntarioقيد التجنيد
CIUSSS-de-l?Est-de-l?Île-de-MontréalMontrealQuebecقيد التجنيد
TIDHI Innovation Inc.TorontoOntarioقيد التجنيد

Chile

المنشأةالمدينةالولاية أو المنطقةالحالة
Centro de Investigación Clínica UC-CICUCSantiagoقيد التجنيد

China

المنشأةالمدينةالولاية أو المنطقةالحالة
Beijing No.6 HospitalBeijingBeijing Municipalityقيد التجنيد
Third Xiangya Hospital Centrel South UniversityChangshaقيد التجنيد
West China Hospital of Sichuan UniversityChengduقيد التجنيد
The second Affiliated Hospital of Guangzhou Medical UniversityGuangzhouقيد التجنيد
Guangzhou First People's HospitalGuangzhouقيد التجنيد
Sir Run Run Shaw Hospital Zhejiang UniversityHangzhouقيد التجنيد
Huizhou Central People's HospitalHuizhouقيد التجنيد
The First Affilliated Hospital of Kunming Medical UniversityKunmingYunnanقيد التجنيد
The Second Affiliated Hospital of Nanchang UniversityNanchangقيد التجنيد
The First Affiliate Hospital of Guangxi Medical UniversityNanningقيد التجنيد
The First Affiliated Hospital of Ningbo UniversityNingboقيد التجنيد
The Affiliated Hospital of Medical College Qingdao UniversityQingdaoقيد التجنيد
Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghaiقيد التجنيد
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghaiقيد التجنيد
Shengjing Hospital of China Medical UniversityShenyangقيد التجنيد
First Affiliated Hospital of Soochow UniversitySuzhouقيد التجنيد
The First Affiliated Hospital of Xiamen UniversityXiamenنشط، دون تجنيد
Zhongshan Hospital Xiamen UniversityXiamenقيد التجنيد

Croatia

المنشأةالمدينةالولاية أو المنطقةالحالة
Borzan PolyclinicOsijekقيد التجنيد
Clinical Hospital Center Sestre MilosrdniceZagrebمسحوب

Czechia

المنشأةالمدينةالولاية أو المنطقةالحالة
Hepato-Gastroenterologie HK, s.r.o.Hradec Královéقيد التجنيد
Fakultni nemocnice OstravaOstrava - Porubaمسحوب

يُدرَج 150 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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