A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis (AMETRINE-SC)
A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Undersøgelse Kontakt Backup
- Navn: Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. and Canada)
- E-mail: global-roche-genentech-trials@gene.com
Studiesteder
-
-
Tennessee
-
Cordova, Tennessee, Forenede Stater, 38018
- Rekruttering
- Gastro One
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Confirmed diagnosis of UC.
- Moderately to severely active UC assessed by modified Mayo Score (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.
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Afimkibart
Participants will receive afimkibart administered as subcutaneous (SC) injection. |
Afimkibart will be administered as SC injection.
Andre navne:
|
|
Placebo komparator: Placebo
Participants will receive placebo adminsitered as SC injection. |
Placebo will be administered as SC injection. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants With Clinical Remission
Tidsramme: At Week 12
|
At Week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Stool Frequency Subscore (SFS)
Tidsramme: From Baseline up to Week 12
|
The Stool Frequency Subscore (SFS) is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal) |
From Baseline up to Week 12
|
|
Change From Baseline in Rectal Bleeding Subscore (RBS)
Tidsramme: From Baseline up to Week 12
|
The Rectal Bleeding Subscore (RBS) is measured on a scale from 0 (no blood seen) to 3 (blood alone passed) |
From Baseline up to Week 12
|
|
Percentage of Participants With Symptomatic Response
Tidsramme: At Week 4
|
At Week 4
|
|
|
Percentage of Participants With Endoscopic Improvement
Tidsramme: At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Endoscopic Remission
Tidsramme: At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Clinical Response
Tidsramme: At Week 12
|
At Week 12
|
|
|
Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
Tidsramme: At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Clinical Remission
Tidsramme: At Week 24
|
At Week 24
|
|
|
Percentage of Participants With Maintenance of Remission
Tidsramme: At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Histologic Improvement
Tidsramme: At Week 24
|
At Week 24
|
|
|
Change From Baseline in Bowel Urgency
Tidsramme: From Baseline through Week 12 and Week 24
|
Bowel urgency will be assessed using two self-reported items over the past 24 hours: presence of bowel urgency (Yes/No) and severity on an 11-point numerical rating scale from 0 (no urgency) to 10 (worst possible urgency) |
From Baseline through Week 12 and Week 24
|
|
Change From Baseline in Abdominal Pain
Tidsramme: From Baseline through Week 12 and Week 24
|
Abdominal pain will be assessed using two self-reported items over the past 24 hours: presence of abdominal pain (Yes/No) and severity on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain) |
From Baseline through Week 12 and Week 24
|
|
Change From Baseline in Fatigue
Tidsramme: From Baseline through Week 12 and Week 24
|
Change in fatigue will be assessed by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. 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 |
From Baseline through Week 12 and Week 24
|
|
Change From Baseline in Health-Related Quality of Life
Tidsramme: From Baseline through Week 12 and Week 24
|
Change in health-related quality of life will be assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) score. 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 |
From Baseline through Week 12 and Week 24
|
|
Change From Baseline in Overall UC Symptoms
Tidsramme: Baseline, Week 2, Week 12 and Week 24
|
Change in overall UC symptoms will be assessed by Patient Global Impression of Change (PGIC). PGIC measures overall change in ulcerative colitis symptoms from "Much better" to "Much worse" |
Baseline, Week 2, Week 12 and Week 24
|
|
Change From Baseline in Overall Severity in UC Symptoms
Tidsramme: Baseline, Week 2, Week 12 and Week 24
|
Change in overall severity of UC symptoms will be assessed by Patient Global Impression of Severity (PGIS). PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe" |
Baseline, Week 2, Week 12 and Week 24
|
|
Incidence and Severity of Adverse Events (AEs)
Tidsramme: From Baseline up to approximately 42 Weeks
|
From Baseline up to approximately 42 Weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CA46523
- 2026-526684-37-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .