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Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of XmAb942 in Participants With Moderate-To-Severe Active Ulcerative Colitis.
Who can join
Ages 18 to 75 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Other protocol defined inclusion/exclusion criteria apply.
About the study
The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).
What is being tested
- XmAb942 (biological)
- Placebo (drug)
Sponsor: Xencor, Inc. · Participants: 270 · Started: Oct 10, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06619990
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.