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
- Albany, Beavercreek, Bradenton, Brandon, Cedar Park, Cordova, Denton, Garland, Georgetown, Houston, Jacksonville, Kingwood, Kissimmee, Louisville, Lubbock, Margate, Oxford, Palmetto Bay, Palo Alto, Raleigh, Richmond, Rochester, San Antonio, Scottsdale, Tampa, Tupelo, Tyler, and Webster, United StatesSee the 28 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 United States
- AlbanyAlbany, United StatesTaking people
- BeavercreekBeavercreek, United StatesTaking people
- BradentonBradenton, United StatesTaking people
- BrandonBrandon, United StatesTaking people
- Cedar ParkCedar Park, United StatesTaking people
- CordovaCordova, United StatesTaking people
- DentonDenton, United StatesTaking people
- GarlandGarland, United StatesTaking people
- GeorgetownGeorgetown, United StatesTaking people
- HoustonHouston, United StatesTaking people
- JacksonvilleJacksonville, United StatesTaking people
- KingwoodKingwood, United StatesTaking people
- KissimmeeKissimmee, United StatesTaking people
- LouisvilleLouisville, United StatesTaking people
- LubbockLubbock, United StatesTaking people
- MargateMargate, United StatesTaking people
- OxfordOxford, United StatesTaking people
- Palmetto BayPalmetto Bay, United StatesTaking people
- Palo AltoPalo Alto, United StatesTaking people
- RaleighRaleigh, United StatesTaking people
- RichmondRichmond, United StatesTaking people
- RochesterRochester, United StatesTaking people
- San AntonioSan Antonio, United StatesTaking people
- ScottsdaleScottsdale, United StatesTaking people
- TampaTampa, United StatesTaking people
- TupeloTupelo, United StatesTaking people
- TylerTyler, United StatesTaking people
- WebsterWebster, United StatesTaking 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.