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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
- Ulcerative Colitis
Trial Status:
Completed
This trial runs in
Cities
- ballinasloe
- Beograd
- Berlin
- Budapest
- Bydgoszcz
- cascina-perseghetto
- Chernivtsi
- Chișinău
- Częstochowa
- Dnipro
- Dnipropetrovs'k
- Dresden
- Düsseldorf
- Elizabeth City
- Gdańsk
- Greenville
- Irkutsk
- Jerusalem
- Katowice
- Kielce
- Kragujevac
- Kropyvnytskyi
- Kyiv
- Las Palmas de Gran Canaria
- London
- Lublin
- Ludwigshafen am Rhein
- Lübeck
- Monza
- Padova
- Palaio Faliro
- Piotrków Trybunalski
- Plovdiv
- Poznań
- Roma
- Rostov
- Salt Lake City
- Samara
- Sankt-Peterburg
- Sliven
- Sofia
- Sopot
- Ternopil
- Thessaloniki
- Torrejón de Ardoz
- Toruń
- Ulm
- Uzhhorod
- Vinnytsia
- Vršac
- Warsaw
- Warszawa
- Wrocław
- Zaporizhzhia
- Zhytomyr
- Zrenjanin
- Łódź
Trial Identifier:
NCT03558152 2017-002350-36 GA39925
Trial Summary
This phase 2, randomized, double-blind, placebo-controlled, parallel-group clinical trial – was done to study “efmarodocokin alfa”, a new medicine for the treatment of patients with ulcerative colitis (UC). This study compared how well efmarodocokin alfa works in comparison to vedolizumab and placebo – when given to people with UC. One hundred and ninety-five people took part at 71 study centers in 16 countries.
Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)
Sponsor
Phase 2
Phase
NCT03558152 , GA39925 , 2017-002350-36
Trial Identifier
efmarodocokin alfa
Treatments
Ulcerative Colitis
Condition
Official Title
A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis
Eligibility Criteria
All
Gender
≥ 18 Years & ≤ 80 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Diagnosis of UC
- Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
- Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
- Use of highly effective contraception as defined by the protocol
Exclusion Criteria
- History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
- History of cancer as defined by the protocol
- Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
- Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
- Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
- History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
- Prior treatment with UTTR1147A
- Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
- Prior treatment with rituximab
- Use of prohibited therapies, as defined by the protocol, prior to randomization
- Congenital or acquired immune deficiency
- Evidence or treatment of infections or history of infections, as defined by the protocol
For the latest version of this information please go to www.forpatients.roche.com