Last updated 7 days ago
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
270 patients around the world
Available in United States, Brazil, Argentina
This study consists of 3 parts, as follows:
Part A: Single ascending dose (SAD) in healthy participants, will entail administration of XmAb942 or matching placebo at 3 different dose levels of XmAb942.
Part B: Multiple ascending dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo at 2 different dose levels of XmAb942.
Part C: Participants with moderately to severely active UC to receive 3 different dose levels of XmAb942 or placebo during a 12-week induction period and single dose level of XmAb942 during a 40-week maintenance period, followed by a 24 week follow-up period.
Xencor, Inc.
270Patients around the world
This study is for people with
Ulcerative colitis
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Parts A and B.Age 18-55.Must be in good health with no significant medical history.Clinical laboratory values within normal range.BMI 18-35 (inclusive).Contraceptive use by men or women consistent with local regulations.Able and willing to provide written informed consent.Part C.Age 18-75.Must be in good health with no significant medical history.UC diagnosis ≥ 3 months prior to screening.Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1.Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy.Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies of UC.Able and willing to provide written informed consent.
- Parts A and B.Any physical or psychological condition that prohibits study completion.History of suicidal behavior or suicidal ideation.Heavy use of nicotine containing products.HIV, hepatitis B and hepatitis C positive.Cardiac arrhythmia, or clinically significant abnormal ECG.Active use of prescription medications within 14 days of Day -1.Active use of over-the-counter, or herbal medication within 7 days of Screening.Other investigational products within 30 days.Blood or plasma donation within 60 days.Pregnant or breastfeeding.Part C.Any physical or psychological condition that prohibits study participation.Diagnosis of Crohn disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.Positive screen for Clostridium difficile (C. Difficile) toxins.HIV, hepatitis B and hepatitis C positive.Cardiac arrhythmia, or clinically significant abnormal ECG.Pregnant or breastfeeding.
SponsorXencor, Inc.
Study typeInterventional
Conditions
Ulcerative colitis
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06619990
