Clinical trial NCT06588855: A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Moderately to Severely Active Ulcerative Colitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of UC
* Moderately to severely active UC assessed by 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
* Males and 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

Primary outcomes:
measure: Percentage of Participants with Clinical Remission
timeFrame: At Week 12
Secondary outcomes:
measure: Change in Partial Modified Mayo Score (pmMS)
timeFrame: From baseline to Week 2
measure: Percentage of Participants with Endoscopic Improvement
timeFrame: At Week 12
measure: Percentage of Participants with Endoscopic Remission
timeFrame: At Week 12
measure: Percentage of Participants with Clinical Response
timeFrame: At Week 12
measure: Percentage of Participants with Histologic Improvement
timeFrame: At Week 12
measure: Percentage of Participants with Histologic Remission
timeFrame: At Week 12
measure: Participants with Histologic-Endoscopic Mucosal Improvement
timeFrame: At Week 12
measure: Percentage of Participants with Histologic-Endoscopic Remission
timeFrame: At Week 12
measure: Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 12
measure: Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 12
measure: Change in Bowel Urgency
timeFrame: Baseline through Week 12
measure: Change in Abdominal Pain
timeFrame: Baseline through Week 12
measure: Change in Fatigue
timeFrame: Baseline to Week 12
measure: Change in Health-Related Quality of Life
timeFrame: Baseline to Week 12
measure: Overall Change in UC Symptoms
timeFrame: Baseline to Week 2 and Week 12
measure: Overall Severity in UC Symptoms
timeFrame: Baseline to Week 2 and Week 12
measure: Incidence and Severity of Adverse Events (AEs)
timeFrame: Up to 30 Weeks after Baseline
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Apple Valley
country: United States
facility: Om Research LLC
state: California
city: Garden Grove
country: United States
facility: Valley View Internal Medicine
state: California
city: Lancaster
country: United States
facility: Gastro Care Associates
state: California
city: Coral Gables
country: United States
facility: Hi Tech and Global Research, LLC
state: Florida
city: Hialeah
country: United States
facility: The Sister Life Research
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Ambert Medical Research
state: Florida
city: Orlando
country: United States
facility: Gastroenterology Institute of Orlando
state: Florida
city: Orlando
country: United States
facility: Digestive and Liver Center of Florida
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research Center, LLC
state: Florida
city: Tampa
country: United States
facility: Santos Research Center, CORP
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Glenview
country: United States
facility: Illinois Gastroenterology Group-Glenview powered by GI Alliance
state: Illinois
city: Gurnee
country: United States
facility: GI Alliance - Gurnee
state: Illinois
city: Wichita
country: United States
facility: Kansas Gastroenterology, LLC under Clinical Trials Network
state: Kansas
city: Southaven
country: United States
facility: Delta Gastroenterology & Endoscopy Center
state: Mississippi
city: Brooklyn
country: United States
facility: Ellipsis Research Group
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Inst for Med Ed&Res
state: New York
city: Queens Village
country: United States
facility: Queens Village Medical Care
state: New York
city: Rochester
country: United States
facility: Gastroenterology Group of Rochester under CTNx
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, P.L.L.C
state: North Carolina
city: Fuquay-Varina
country: United States
facility: Omega Research North Carolina, LLC
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Hilliard
country: United States
facility: Ohio State University
state: Ohio
city: Uniontown
country: United States
facility: Frontier Clinical Re search, LLC
state: Pennsylvania
city: Greenville
country: United States
facility: Gastroenterology Associates, PA PA of Greenville
state: South Carolina
city: Georgetown
country: United States
facility: Amel Med LLC
state: Texas
city: Harlingen
country: United States
facility: Cano Medical Center
state: Texas
city: Harlingen
country: United States
facility: Texas Digestive Specialists
state: Texas
city: Lansdowne Town Center
country: United States
facility: Emeritas Research Group
state: Virginia
city: Ciudad Autonoma Bs As
country: Argentina
facility: Hospital Britanico
city: Quilmes
country: Argentina
facility: Instituto Medico CER
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
state: Queensland
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Aalst
country: Belgium
facility: AZORG Campus Aalst-Moorselbaan
city: Brussels
country: Belgium
facility: CHU St Pierre (St Pierre)
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: London
country: Canada
facility: London Health Sciences Centre Uni Campus
state: Ontario
city: Santiago
country: Chile
facility: Centro de Investigación Clínica UC-CICUC
city: Beijing
country: China
facility: Beijing No.6 Hospital
state: Beijing
city: Kunming
country: China
facility: The First Affilliated Hospital of Kunming Medical University
state: Yunnan
city: Changsha
country: China
facility: Third Xiangya Hospital Centrel South University
city: Chengdu City
country: China
facility: West China Hospital of Sichuan University
city: Guangzhou City
country: China
facility: The second Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
city: Nanchang City
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanning
country: China
facility: The First Affiliate Hospital of Guangxi Medical University
city: Ningbo City
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College Qingdao University
city: Shanghai City
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
city: Osijek
country: Croatia
facility: Borzan Polyclinic
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Ålborg
country: Denmark
facility: Ålborg Universitets Hospital
city: Chambray les Tours
country: France
facility: CHU Tours - Hôpital Trousseau
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand - Hôtel Dieu
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Nimes
country: France
facility: Polyclinique Grand Sud
city: Vandoeuvre-les-nancy
country: France
facility: Hôpital de Brabois Adultes
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Lueneburg
country: Germany
facility: Medizinisches Zentrum Klinikum Lueneburg
city: Budapest
country: Hungary
facility: Észak-Pesti Centrumkórház-Honvédkórház
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
city: Szombathely
country: Hungary
facility: Vas-Oxy Egeszsegugyi Kft
city: Székesfehérvár
country: Hungary
facility: Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico Di Roma
state: Lazio
city: Roma
country: Italy
facility: Ospedale Isola Tiberina Gemelli
state: Lazio
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
state: Lombardia
city: Monza MI
country: Italy
facility: Azienda Ospedaliera San Gerardo di Monza
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
state: Veneto
city: Veracruz
country: Mexico
facility: FAICIC S de R.L. de C.V
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: ?ód?
country: Poland
facility: Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
city: Bia?ystok
country: Poland
facility: Gastromed Kralisz, Romatowski, Stachurska sp.j.
city: Bydgoszcz
country: Poland
facility: Medical Center Kermed
city: Grudzadz
country: Poland
facility: Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
city: Knurów
country: Poland
facility: MZ Badania Slowik Zymla Sp.j.
city: Kraków
country: Poland
facility: Centrum Medyczne Promed
city: Lublin
country: Poland
facility: Medrise sp z o.o
city: Pozna?
country: Poland
facility: EMC Instytut Medyczny SA
city: Pozna?
country: Poland
facility: Gabinety Lekarskie Rivermed
city: Pozna?
country: Poland
facility: Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Zdrowia-MDM
city: Warszawa
country: Poland
facility: Medon Clinical Research sp. z o.o
city: Wroc?aw
country: Poland
facility: PlanetMed sp. z o.o.
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Hospital da Luz Lisboa
city: Portimao
country: Portugal
facility: Centro Hospitalar do Algarve - Hospital de Portimao
city: Porto
country: Portugal
facility: Hospital de Sao Joao
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
city: Viseu
country: Portugal
facility: Hospital Sao Teotonio
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group LLC
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic"
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Zaragoza
country: Spain
facility: Hospital Clinico Univ. Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Chiang Mai
country: Thailand
facility: Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
city: Chonburi
country: Thailand
facility: Burapha University Hospital
city: Ubonratchathani
country: Thailand
facility: Sunpasitthiprasong Hospital
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: Llanrhystud
country: United Kingdom
facility: Bronglais General Hospital
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: