A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
- Autoimmune Disorder
- Inflammatory Bowel Disease (IBD)
- Ulcerative Colitis
Completed
- Adelaide
- ajka
- Amiens
- Balatonfüred
- Bengaluru
- Berlin
- Białystok
- Bloemfontein
- Boston
- București
- Budapest
- Bunkyo City
- caldas
- cascina-perseghetto
- castellana-grotte
- Chicago
- Ciudad de México
- Clearwater
- Concord
- corby
- Dothan
- Fairfax
- Farmington
- fortitude-valley
- Fuenlabrada
- Fukuoka
- Gliwice
- Greenville
- Guadalajara
- Halle (Saale)
- Hamden
- high-wycombe
- Houston
- Iowa City
- İstanbul
- Jaipur
- Johannesburg
- Kempton Park
- Kharkiv
- knurow
- Kocaeli
- Kragujevac
- Krung Thep Maha Nakhon
- Kurume
- Kyiv
- Las Vegas
- Lazio
- lenasia
- Leuven
- Lille
- Little Rock
- Mersin
- Milwaukee
- Moscow
- Mérida
- Nagakute
- Nantes
- Napoli
- Nashville
- negrar-di-valpolicella
- New York
- Newport Beach
- Nitriansky kraj
- Northwood
- Nottingham
- Novosibirsk
- oldsmar
- Omsk
- orpington
- oullins-pierre-benite
- Padova
- Perm
- Philadelphia
- pre_ov
- Pretoria
- Prešovský kraj
- Pune
- Pyatigorsk
- Rajkot
- Roswell
- Sakura
- Samara
- San Antonio
- Santiago de Querétaro
- Sapporo
- Saratov
- Sendai
- Shinjuku City
- Smolensk
- Sofia
- Sopot
- spring-hill
- subotica
- Surat
- sutton-coldfield
- Szczecin
- Szekszárd
- Székesfehérvár
- tambon-kho-hong
- Tampa
- tapolca
- Tatabánya
- Tomsk
- tyumen
- Veszprém
- Vinnytsia
- Warsaw
- Warszawa
- Wauwatosa
- Wrocław
- Yaroslavl Oblast
- Zaporizhzhia
- zonguldak
- Zrenjanin
NCT04090411 TL1A Tuscany 2 2019-002698-74 B7541007
Trial Summary
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate The Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate To Severe Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:-
- A diagnosis of UC for ≥3 months.
- Participants with moderate to severe active UC as defined by a Total Mayo Score of
≥6, and an endoscopic subscore of ≥2.
- Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
- Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.
- Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
- Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
- Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
- 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
- Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses
For the latest version of this information please go to www.forpatients.roche.com