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

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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 Teilnehmende gesucht374 Studienzentren38 Länder

Kategorien

Gastroenterologie und Hepatologie100%

In 1 Register registriert

ClinicalTrials.govNCT06819878Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 5 Tagen

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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.

Zusammenfassung

Erkrankungen

Moderately to Severely Active Crohns Disease

Eignung

Eignung
Geschlecht	Alle
Alter	16 Years – 80 Years
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	DOUBLE (2)
Teilnahme	600 Teilnehmende gesucht

Sponsor und Mitwirkende

Hoffmann-La Roche Sponsor
Chugai Pharmaceutical Mitwirkende

Studienarme und Interventionen

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.

Interventionen

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

Endpunkte

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

Daten

Daten
Startdatum	17. März 2025 (tatsächlich)
Primärer Abschluss	31. Dezember 2028 (geschätzt)
Abschluss	31. Dezember 2033 (geschätzt)
Erstveröffentlichung	11. Februar 2025 (tatsächlich)
Zuletzt aktualisiert	16. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	September 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

360 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Bundesland oder Region	Status
Hospital Britanico	Ciudad Autonoma Bs As		Rekrutiert
Hospital Provincial del Centenario	Rosario		Rekrutiert

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Flinders Medical Center	Adelaide	South Australia	Rekrutiert
Lyell McEwin Hospital	Adelaide	South Australia	Rekrutiert
Northern Hospital	Epping	Victoria	Rekrutiert
The Canberra Hospital	Garran	Australian Capital Territory	Rekrutiert
Royal Brisbane and Women's Hospital	Herston	Queensland	Rekrutiert
Fiona Stanley Hospital	Murdoch	Western Australia	Rekrutiert
Royal Perth Hospital	Perth	Western Australia	Rekrutiert
Mater Misericordiae Limited	South Brisbane	Queensland	Rekrutiert
Royal Prince Alfred Hospital	Sydney	New South Wales	Rekrutiert
Princess Alexandra Hospital	Woolloongabba	Queensland	Rekrutiert

Austria

Austria
Einrichtung	Stadt	Status
Medizinische Universität Innsbruck	Innsbruck	Rekrutiert
Universitätsklinikum St. Pölten	Sankt Pölten	Rekrutiert
Medizinische Universität Wien	Vienna	Rekrutiert
Barmherzige Brüder Wien	Vienna	Rekrutiert

Belgium

Belgium
Einrichtung	Stadt	Status
AZORG Campus Aalst-Moorselbaan	Aalst	Rekrutiert
Cliniques Universitaires St-Luc	Brussels	Zurückgezogen
UZ Antwerpen	Edegem	Rekrutiert
AZ Maria Middelares	Ghent	Rekrutiert
AZ Sint Lucas (Sint Lucas)	Ghent	Rekrutiert
Jessa Zkh (Campus Virga Jesse)	Hasselt	Zurückgezogen
CHC MontLégia	Liège	Zurückgezogen
CHU de Liège (Sart Tilman)	Liège	Rekrutiert
CHU HELORA - Hôpital de Mons - Site Kennedy	Mons	Rekrutiert
Vitaz	Sint-Niklaas	Rekrutiert

Brazil

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

Bulgaria

Bulgaria
Einrichtung	Stadt	Status
MBAL Burgasmed	Burgas	Rekrutiert
MHAT St. Ivan Rilski	Gorna Oryahovitsa	Rekrutiert
Futuremeds Medical Center	Plovdiv	Rekrutiert
MHAT Saint Karidad EAD	Plovdiv	Rekrutiert
Tokuda Hospital	Sofia	Rekrutiert

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
South Edmonton Gastroenterology	Edmonton	Alberta	Rekrutiert
C.I.C. Mauricie	Trois-Rivières	Quebec	Zurückgezogen
TDDA Specialty Research	Vaughan	Ontario	Rekrutiert

Chile

Chile
Einrichtung	Stadt	Status
Hospital Guillermo Grant Benavente	Concepción	Rekrutiert
Medwal	Santiago	Rekrutiert
Clinica Universidad de Los Andes	Santiago	Rekrutiert

China

China
Einrichtung	Stadt	Status
Peking University Third Hospital	Beijing	Rekrutiert
the First Hospital of Jilin University	Changchun	Rekrutiert
Third Xiangya Hospital Centrel South University	Changsha	Rekrutiert
West China Hospital of Sichuan University	Chengdu	Rekrutiert
Chongqing General Hospital	Chongqing	Rekrutiert

324 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

16. September 2026
Studienzentrum hinzugefügt
1 site added (374 total)
373374
20. August 2026
Studienzentrum hinzugefügt
1 site added (373 total)
372373

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