Tests XmAb942 in healthy people, then in people with ulcerative colitis
Tests XmAb942 safety in healthy adults, then its effect in ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Key facts
- Where
- London, Montreal, Scarborough, and Vancouver, CanadaSee the 4 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06619990, who can take part
Where in Canada
- LondonLondon, CanadaTaking people
- MontrealMontreal, CanadaTaking people
- ScarboroughScarborough, CanadaTaking people
- VancouverVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xencor, Inc.
- Trial code
- NCT06619990
- Record updated
- 30 October 2026
- Original description
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).Read full original descriptionShow less
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.
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).
Inclusion: 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: 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; Any physical or psychological condition that prohibits study completion; History of suicidal behavior or suicidal ideation; HIV, hepatitis B and hepatitis C positive; Cardiac arrhythmia, or clinically significant abnormal ECG; 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; HIV, hepatitis B and hepatitis C positive; Cardiac arrhythmia, or clinically significant abnormal ECG; Parts A and B; Heavy use of nicotine containing products; Blood or plasma donation within 60 days; Pregnant or breastfeeding; Part C; Positive screen for Clostridium difficile (C. Difficile) toxins; Pregnant or breastfeeding; Other protocol defined inclusion/exclusion criteria apply.