NCT06819878ClinicalTrials.gov

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

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 Crohn's Disease

En reclutamientoAdmite participantes ahora, según el registro.

Contactar con este estudio

En resumen

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Fase 3600 participantes buscados374 centros38 países

Categorías

Gastroenterología y hepatología100%

Registrado en 1 registro

ClinicalTrials.govNCT06819878Abrir este registro en ClinicalTrials.govSincronizado hace 5 días

Un mismo estudio puede estar registrado en varios registros. Lo mostramos una sola vez y enlazamos con todos los registros que tenemos.

La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

¿Le interesa este estudio?

Iniciar sesión o cree una cuenta para registrar su interés y seguir este estudio.

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 2025-02-11; recorded start 2025-03-17
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: 372 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: 600 participants (target), run at 374 sites, across 38 countries.

How this score is built

Enrolment27/40
600 participants (target)
Site count25/25
372 sites
Country count15/15
38 countries
Planned duration10/10
Planned over about 107 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.

Resumen

Afecciones

Moderately to Severely Active Crohns Disease

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	16 Years – 80 Years
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Confirmed diagnosis of CD * Moderately to severely active CD * Bodyweight \>= 40 kilogram (kg) * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy * Males and females of childbearing potential must meet protocol criteria for contraception requirements Exclusion Criteria: * Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis * Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum) * Diagnosis of short gut or short bowel syndrome * Presence of an ileostomy, colostomy or ileoanal pouch * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * Presence of abdominal or perianal abscess * Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings * Current diagnosis or suspicion of primary sclerosing cholangitis * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia * History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening * 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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	DOUBLE (2)
Inscripción	600 participantes buscados

Patrocinador y colaboradores

Hoffmann-La Roche Patrocinador
Chugai Pharmaceutical Colaboradores

Grupos e intervenciones

Arm 2: AfimkibartEXPERIMENTAL
Participants will receive afimkibart IV followed by afimkibart SC injection.
Arm 3: PlaceboPLACEBO_COMPARATOR
Participants will receive placebo IV followed by placebo SC.
Arm 1: AfimkibartEXPERIMENTAL
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.

Intervenciones

Fármaco Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Fármaco Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Variables de resultado

Variable de resultado principal
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Plazo At Week 52
Variable de resultado principal
Percentage of Participants with Endoscopic Response
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Plazo At Week 52
Variable de resultado secundaria
Percentage of Participants with Clinical Remission
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Plazo At Week 12
Variable de resultado secundaria
Percentage of Participants with Endoscopic Response
Percentage of participants achieving a decrease in SES-CD of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Plazo At Week 12
Variable de resultado secundaria
Percentage of Participants with Symptomatic Remission
Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
Plazo At Week 12
Variable de resultado secundaria
Percentage of Participants with Endoscopic Remission
Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1.
Plazo At Week 12
Variable de resultado secundaria
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Plazo At Week 12
Variable de resultado secundaria
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Daily average number of liquid or very soft stools over 7 days.
Plazo Baseline through Week 12
Variable de resultado secundaria
Average of Daily Abdominal Pain Scores in the Past Week (APS)
The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain.
Plazo Baseline through Week 12
Variable de resultado secundaria
Percentage of Participants with Endoscopic Remission
Percentage of participants with SES-CD=0 to 4 with decrease from baseline \>=2 and no subscore \>1 .
Plazo At Week 52
Variable de resultado secundaria
Percentage of Participants with Symptomatic Remission
Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
Plazo At Week 52
Variable de resultado secundaria
Percentage of Participants with Corticosteroid-free Clinical Remission
Percentage of participants with clinical remission at Week 52 and no use of corticosteroids for CD at least 8 weeks prior to Week 52.
Plazo At Week 52
Variable de resultado secundaria
Maintenance of Clinical Remission
Percentage of participants with clinical remission at both Weeks 12 and 52.
Plazo At Weeks 12 and 52
Variable de resultado secundaria
Maintenance of Endoscopic Response
Percentage of participants with endoscopic response at both Weeks 12 and 52.
Plazo At Weeks 12 and 52
Variable de resultado secundaria
Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52
Percentage of participants achieving a CDAI score of \<150 and SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1 at Week 52.
Plazo At Week 52
Variable de resultado secundaria
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Plazo At Week 52
Variable de resultado secundaria
Bowel Urgency
Bowel urgency from baseline through week 12 and week 52. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe."
Plazo Baseline through Week 12 and Week 52
Variable de resultado secundaria
Fatigue
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much."
Plazo Baseline to Week 12 and Week 52
Variable de resultado secundaria
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Change in IBDQ score from baseline to week 12 and 52. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life.
Plazo Baseline to Week 12 and Week 52
Variable de resultado secundaria
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a CDAI score of \<150 at Week 12 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Plazo At Week 12
Variable de resultado secundaria
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a CDAI score of \<150 at Week 52 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Plazo At Week 52
Variable de resultado secundaria
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a decrease in SES-CD of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Plazo At Week 12
Variable de resultado secundaria
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a decrease in SES-CD of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Plazo At Week 52
Variable de resultado secundaria
Percentage of Participants with Clinical Response
Percentage of participants with a decrease \>=100 in CDAI from baseline.
Plazo At Week 12
Variable de resultado secundaria
Percentage of Participants with Symptomatic Response
Percentage of participants with a decrease \>=30% in both SF and APS, with neither being greater than baseline.
Plazo At Week 12
Variable de resultado secundaria
Overall Change in CD Symptoms
Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6, 12 and 52. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
Plazo Baseline to Weeks 2, 6, 12 and 52
Variable de resultado secundaria
Overall Severity in CD Symptoms
Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6, 12 and 52. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
Plazo Baseline to Weeks 2, 6, 12 and 52
Variable de resultado secundaria
Change in General Well-being
The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible.
Plazo Baseline through Week 52
Variable de resultado secundaria
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.
Plazo Up to 70 Weeks after Baseline
Variable de resultado secundaria
Percentage of Participants with a Presence of Draining Fistulas
Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.
Plazo Baseline through Week 12 and Week 52

Fechas

Fechas
Fecha de inicio	17 de marzo de 2025 (real)
Finalización principal	31 de diciembre de 2028 (estimada)
Finalización	31 de diciembre de 2033 (estimada)
Primera publicación	11 de febrero de 2025 (real)
Última actualización	16 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	septiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

360 centros están en reclutamiento

Argentina

Argentina
Centro	Ciudad	Estado o región	Estado
Hospital Britanico	Ciudad Autonoma Bs As		En reclutamiento
Hospital Provincial del Centenario	Rosario		En reclutamiento

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Flinders Medical Center	Adelaide	South Australia	En reclutamiento
Lyell McEwin Hospital	Adelaide	South Australia	En reclutamiento
Northern Hospital	Epping	Victoria	En reclutamiento
The Canberra Hospital	Garran	Australian Capital Territory	En reclutamiento
Royal Brisbane and Women's Hospital	Herston	Queensland	En reclutamiento
Fiona Stanley Hospital	Murdoch	Western Australia	En reclutamiento
Royal Perth Hospital	Perth	Western Australia	En reclutamiento
Mater Misericordiae Limited	South Brisbane	Queensland	En reclutamiento
Royal Prince Alfred Hospital	Sydney	New South Wales	En reclutamiento
Princess Alexandra Hospital	Woolloongabba	Queensland	En reclutamiento

Austria

Austria
Centro	Ciudad	Estado
Medizinische Universität Innsbruck	Innsbruck	En reclutamiento
Universitätsklinikum St. Pölten	Sankt Pölten	En reclutamiento
Medizinische Universität Wien	Vienna	En reclutamiento
Barmherzige Brüder Wien	Vienna	En reclutamiento

Belgium

Belgium
Centro	Ciudad	Estado
AZORG Campus Aalst-Moorselbaan	Aalst	En reclutamiento
Cliniques Universitaires St-Luc	Brussels	Retirado
UZ Antwerpen	Edegem	En reclutamiento
AZ Maria Middelares	Ghent	En reclutamiento
AZ Sint Lucas (Sint Lucas)	Ghent	En reclutamiento
Jessa Zkh (Campus Virga Jesse)	Hasselt	Retirado
CHC MontLégia	Liège	Retirado
CHU de Liège (Sart Tilman)	Liège	En reclutamiento
CHU HELORA - Hôpital de Mons - Site Kennedy	Mons	En reclutamiento
Vitaz	Sint-Niklaas	En reclutamiento

Brazil

Brazil
Centro	Ciudad	Estado o región	Estado
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu	Botucatu	São Paulo	En reclutamiento
L2 Ip Instituto de Pesquisas Clinicas Ltda ME	Brasília	Federal District	En reclutamiento
Centro de Pesquisa São Lucas	Campinas	São Paulo	En reclutamiento
Centro Digestivo de Curitiba	Curitiba	Paraná	En reclutamiento
Hospital de Clinicas de Porto Alegre X	Porto Alegre	Rio Grande do Sul	En reclutamiento
CLIAGEN - Clinica de Atenção em Gastroenterologia, Especialidades e Nutrição	Salvador	Estado de Bahia	En reclutamiento
CPQuali Pesquisa Clinica Ltda	São Paulo	São Paulo	En reclutamiento
BR Trials - Pesquisa Clínica	São Paulo	São Paulo	En reclutamiento

Bulgaria

Bulgaria
Centro	Ciudad	Estado
MBAL Burgasmed	Burgas	En reclutamiento
MHAT St. Ivan Rilski	Gorna Oryahovitsa	En reclutamiento
Futuremeds Medical Center	Plovdiv	En reclutamiento
MHAT Saint Karidad EAD	Plovdiv	En reclutamiento
Tokuda Hospital	Sofia	En reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
South Edmonton Gastroenterology	Edmonton	Alberta	En reclutamiento
C.I.C. Mauricie	Trois-Rivières	Quebec	Retirado
TDDA Specialty Research	Vaughan	Ontario	En reclutamiento

Chile

Chile
Centro	Ciudad	Estado
Hospital Guillermo Grant Benavente	Concepción	En reclutamiento
Medwal	Santiago	En reclutamiento
Clinica Universidad de Los Andes	Santiago	En reclutamiento

China

China
Centro	Ciudad	Estado
Peking University Third Hospital	Beijing	En reclutamiento
the First Hospital of Jilin University	Changchun	En reclutamiento
Third Xiangya Hospital Centrel South University	Changsha	En reclutamiento
West China Hospital of Sichuan University	Chengdu	En reclutamiento
Chongqing General Hospital	Chongqing	En reclutamiento

En el registro figuran 324 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

16 de septiembre de 2026
Centro añadido
1 site added (374 total)
373374
20 de agosto de 2026
Centro añadido
1 site added (373 total)
372373

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06819878