119
Participants
Start Date
February 6, 2017
Primary Completion Date
October 18, 2019
Study Completion Date
October 18, 2019
RO7062931
Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts QW or Q2W. In Part 2c, participants will receive RO7062831 QW on top of another therapy for up to 24 or 48 weeks.
Placebo
Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.
Immune Modulator
Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks.
Taipei Veterans General Hospital, Taipei
Chang Gung Medical Foundation Linkou Branch, Taoyuan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Auckland Clinical Studies, Auckland
Middlemore Hospital, Auckland
Royal Melbourne Hospital, Parkville
Linear Clinical Research Limited, Nedlands
Siriraj Hospital; Dept. of Medicine, Bangkok
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai
National University Hospital; Dept of Gastroenterology & Hepatology, Singapore
University of Ulsan College of Medicine, Asan Medical Center, Digestive Disease Center, Seoul
Singapore General Hospital; Gastroenterology & Hepatology, Singapore
Queen Mary Hospital, Hong Kong
Prince of Wales Hospital, Shatin, New Territories
Chang Gung Medical Foundation - Kaohsiung Branch, Kaohsiung City
Chuncheon Sacred Heart Hospital, Gangwon-Do
Gangnam Severance Hospital, Seoul
ChungAng University Hospital, Seoul
SMG-SNU Boramae Medical Center, Seoul
Hoffmann-La Roche
INDUSTRY