A Phase I Study of RO7021610 in Patients with Ulcerative Colitis

Authors
Category Primary study
Registry of TrialsJapan Pharmaceutical Information Center
Year 2019
INTERVENTION: Intervention name : RO7021610 INN of the intervention : ‐ Dosage And administration of the intervention : RO7021610 will be administrated repeatedly by IV. Control intervention name : Placebo INN of the control intervention : ‐ Dosage And administration of the control intervention : Placebo will be administrated repeatedly by IV. CONDITION: Ulcerative colitis PRIMARY OUTCOME: safety, pharmacokinetics; Safety and PK SECONDARY OUTCOME: other; anti‐drug antibody INCLUSION CRITERIA: ‐ Japanese patients with ulcerative colitis ‐ Diagnosis of ulcerative colitis established and confirmed at least 3 months prior to screening initiation ‐ Diagnosis of moderate‐to‐severe ulcerative colitis (Mayo endoscopic subscore >=2) ‐ Inadequate response, loss of response, or intolerance to prior treatment for moderate to severe ulcerative colitis
Epistemonikos ID: 1e1756f98568c84c0d368732bc55896ec4455060
First added on: Aug 24, 2024