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).
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- 3. fázis
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.
- Telefonszám: 888-662-6728 (U.S. and Canada)
- E-mail: global-roche-genentech-trials@gene.com
Tanulmányi helyek
-
-
Tennessee
-
Cordova, Tennessee, Egyesült Államok, 38018
- Toborzás
- Gastro One
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Négyszeres
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Afimkibart
Participants will receive afimkibart administered as subcutaneous (SC) injection. |
Afimkibart will be administered as SC injection.
Más nevek:
|
|
Placebo Comparator: Placebo
Participants will receive placebo adminsitered as SC injection. |
Placebo will be administered as SC injection. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
|---|---|
|
Percentage of Participants With Clinical Remission
Időkeret: At Week 12
|
At Week 12
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change From Baseline in Stool Frequency Subscore (SFS)
Időkeret: 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)
Időkeret: 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
Időkeret: At Week 4
|
At Week 4
|
|
|
Percentage of Participants With Endoscopic Improvement
Időkeret: At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Endoscopic Remission
Időkeret: At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Clinical Response
Időkeret: At Week 12
|
At Week 12
|
|
|
Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
Időkeret: At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Clinical Remission
Időkeret: At Week 24
|
At Week 24
|
|
|
Percentage of Participants With Maintenance of Remission
Időkeret: At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Histologic Improvement
Időkeret: At Week 24
|
At Week 24
|
|
|
Change From Baseline in Bowel Urgency
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: From Baseline up to approximately 42 Weeks
|
From Baseline up to approximately 42 Weeks
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi igazgató: Clinical Trials, Hoffmann-La Roche
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- CA46523
- 2026-526684-37-00 (Ctis)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .