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 recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

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).

Phase 3600 participants recherchés374 sites38 pays

Catégories

Gastro-entérologie et hépatologie100%

Enregistré dans 1 registre

ClinicalTrials.govNCT06819878Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 5 jours

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

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.

Résumé

Affections

Moderately to Severely Active Crohns Disease

Éligibilité

Éligibilité
Sexe	Tous
Âges	16 Years – 80 Years
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	DOUBLE (2)
Recrutement	600 participants recherchés

Promoteur et collaborateurs

Hoffmann-La Roche Promoteur
Chugai Pharmaceutical Collaborateurs

Groupes et interventions

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.

Interventions

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

Critères de jugement

Critère de jugement 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.
Délai At Week 52
Critère de jugement 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.
Délai At Week 52
Critère de jugement secondaire
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.
Délai At Week 12
Critère de jugement secondaire
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.
Délai At Week 12
Critère de jugement secondaire
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.
Délai At Week 12
Critère de jugement secondaire
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.
Délai At Week 12
Critère de jugement secondaire
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Délai At Week 12
Critère de jugement secondaire
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.
Délai Baseline through Week 12
Critère de jugement secondaire
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.
Délai Baseline through Week 12
Critère de jugement secondaire
Percentage of Participants with Endoscopic Remission
Percentage of participants with SES-CD=0 to 4 with decrease from baseline \>=2 and no subscore \>1 .
Délai At Week 52
Critère de jugement secondaire
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.
Délai At Week 52
Critère de jugement secondaire
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.
Délai At Week 52
Critère de jugement secondaire
Maintenance of Clinical Remission
Percentage of participants with clinical remission at both Weeks 12 and 52.
Délai At Weeks 12 and 52
Critère de jugement secondaire
Maintenance of Endoscopic Response
Percentage of participants with endoscopic response at both Weeks 12 and 52.
Délai At Weeks 12 and 52
Critère de jugement secondaire
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.
Délai At Week 52
Critère de jugement secondaire
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Délai At Week 52
Critère de jugement secondaire
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."
Délai Baseline through Week 12 and Week 52
Critère de jugement secondaire
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."
Délai Baseline to Week 12 and Week 52
Critère de jugement secondaire
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.
Délai Baseline to Week 12 and Week 52
Critère de jugement secondaire
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.
Délai At Week 12
Critère de jugement secondaire
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.
Délai At Week 52
Critère de jugement secondaire
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.
Délai At Week 12
Critère de jugement secondaire
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.
Délai At Week 52
Critère de jugement secondaire
Percentage of Participants with Clinical Response
Percentage of participants with a decrease \>=100 in CDAI from baseline.
Délai At Week 12
Critère de jugement secondaire
Percentage of Participants with Symptomatic Response
Percentage of participants with a decrease \>=30% in both SF and APS, with neither being greater than baseline.
Délai At Week 12
Critère de jugement secondaire
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".
Délai Baseline to Weeks 2, 6, 12 and 52
Critère de jugement secondaire
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".
Délai Baseline to Weeks 2, 6, 12 and 52
Critère de jugement secondaire
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.
Délai Baseline through Week 52
Critère de jugement secondaire
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.
Délai Up to 70 Weeks after Baseline
Critère de jugement secondaire
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.
Délai Baseline through Week 12 and Week 52

Dates

Dates
Date de début	17 mars 2025 (réelle)
Achèvement principal	31 décembre 2028 (estimée)
Achèvement	31 décembre 2033 (estimée)
Première publication	11 février 2025 (réelle)
Dernière mise à jour	16 septembre 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	septembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

360 sites sont en recrutement

Argentina

Argentina
Établissement	Ville	État ou région	Statut
Hospital Britanico	Ciudad Autonoma Bs As		En recrutement
Hospital Provincial del Centenario	Rosario		En recrutement

Australia

Australia
Établissement	Ville	État ou région	Statut
Flinders Medical Center	Adelaide	South Australia	En recrutement
Lyell McEwin Hospital	Adelaide	South Australia	En recrutement
Northern Hospital	Epping	Victoria	En recrutement
The Canberra Hospital	Garran	Australian Capital Territory	En recrutement
Royal Brisbane and Women's Hospital	Herston	Queensland	En recrutement
Fiona Stanley Hospital	Murdoch	Western Australia	En recrutement
Royal Perth Hospital	Perth	Western Australia	En recrutement
Mater Misericordiae Limited	South Brisbane	Queensland	En recrutement
Royal Prince Alfred Hospital	Sydney	New South Wales	En recrutement
Princess Alexandra Hospital	Woolloongabba	Queensland	En recrutement

Austria

Austria
Établissement	Ville	Statut
Medizinische Universität Innsbruck	Innsbruck	En recrutement
Universitätsklinikum St. Pölten	Sankt Pölten	En recrutement
Medizinische Universität Wien	Vienna	En recrutement
Barmherzige Brüder Wien	Vienna	En recrutement

Belgium

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

Brazil

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

Bulgaria

Bulgaria
Établissement	Ville	Statut
MBAL Burgasmed	Burgas	En recrutement
MHAT St. Ivan Rilski	Gorna Oryahovitsa	En recrutement
Futuremeds Medical Center	Plovdiv	En recrutement
MHAT Saint Karidad EAD	Plovdiv	En recrutement
Tokuda Hospital	Sofia	En recrutement

Canada

Canada
Établissement	Ville	État ou région	Statut
South Edmonton Gastroenterology	Edmonton	Alberta	En recrutement
C.I.C. Mauricie	Trois-Rivières	Quebec	Retiré
TDDA Specialty Research	Vaughan	Ontario	En recrutement

Chile

Chile
Établissement	Ville	Statut
Hospital Guillermo Grant Benavente	Concepción	En recrutement
Medwal	Santiago	En recrutement
Clinica Universidad de Los Andes	Santiago	En recrutement

China

China
Établissement	Ville	Statut
Peking University Third Hospital	Beijing	En recrutement
the First Hospital of Jilin University	Changchun	En recrutement
Third Xiangya Hospital Centrel South University	Changsha	En recrutement
West China Hospital of Sichuan University	Chengdu	En recrutement
Chongqing General Hospital	Chongqing	En recrutement

324 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

16 septembre 2026
Site ajouté
1 site added (374 total)
373374
20 août 2026
Site ajouté
1 site added (373 total)
372373

Registre: ClinicalTrials.gov · NCT########

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