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.
- Ulcerative Colitis (UC)
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Xencor, Inc.
- Enrolment target
- 270
- Started
- 10 October 2024
- Main results due
- December 2027
- Study sites
- 98
- Registry updated
- 29 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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.
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(98)
Xencor Investigative Site
Scottsdale, Arizona, United States
Recruiting
Xencor Investigative Site
Palo Alto, California, United States
Recruiting
Xencor Investigative Site
Bradenton, Florida, United States
Recruiting
Xencor Investigative Site
Brandon, Florida, United States
Recruiting
Xencor Investigative Site
Jacksonville, Florida, United States
Recruiting
Xencor Investigative Site
Kissimmee, Florida, United States
Recruiting
Xencor Investigative Site
Margate, Florida, United States
Recruiting
Xencor Investigative Site
Palmetto Bay, Florida, United States
Recruiting
Xencor Investigative Site
Tampa, Florida, United States
Recruiting
Xencor Investigative Site
Tampa, Florida, United States
Recruiting
Xencor Investigative Site
Louisville, Kentucky, United States
Recruiting
Xencor Investigative Site
Oxford, Mississippi, United States
Recruiting
Xencor Investigative Site
Tupelo, Mississippi, United States
Recruiting
Xencor Investigative Site
Albany, New York, United States
Recruiting
Xencor Investigative Site
Rochester, New York, United States
Recruiting
Xencor Investigative Site
Raleigh, North Carolina, United States
Recruiting
Xencor Investigative Site
Beavercreek, Ohio, United States
Recruiting
Xencor Investigative Site
Cordova, Tennessee, United States
Recruiting
Xencor Investigative Site
Cedar Park, Texas, United States
Recruiting
Xencor Investigative Site
Denton, Texas, United States
Recruiting
Xencor Investigative Site
Garland, Texas, United States
Recruiting
Xencor Investigative Site
Georgetown, Texas, United States
Recruiting
Xencor Investigative Site
Houston, Texas, United States
Recruiting
Xencor Investigative Site
Houston, Texas, United States
Recruiting
Xencor Investigative Site
Kingwood, Texas, United States
Recruiting
Xencor Investigative Site
Lubbock, Texas, United States
Recruiting
Xencor Investigative Site
San Antonio, Texas, United States
Recruiting
Xencor Investigative Site
Tyler, Texas, United States
Recruiting
Xencor Investigative Site
Webster, Texas, United States
Recruiting
Xencor Investigative Site
Richmond, Virginia, United States
Recruiting
Xencor Investigative Site
Buenos Aires, Argentina
Recruiting
Xencor Investigative Site
Buenos Aires, Argentina
Recruiting
Xencor Investigative Site
Buenos Aires, Argentina
Recruiting
Xencor Investigative Site
Rosario, Argentina
Recruiting
Xencor Investigative Site
San Miguel de Tucumán, Argentina
Recruiting
Xencor Investigative Site
Adelaide, Australia
Recruiting
Xencor Investigative Site
Joondalup, Australia
Completed
Xencor Investigative Site
Melbourne, Australia
Recruiting
Xencor Investigative Site
Nedlands, Australia
Completed
Xencor Investigative Site
South Brisbane, Australia
Recruiting
Xencor Investigative Site
Southport, Australia
Recruiting
Xencor Investigative Site
Wollongong, Australia
Recruiting
Xencor Investigative Site
Campinas, Brazil
Recruiting
Xencor Investigative Site
Fortaleza, Brazil
Recruiting
Xencor Investigative Site
Macaé, Brazil
Recruiting
Xencor Investigative Site
Porto Alegre, Brazil
Recruiting
Xencor Investigative Site
Salvador, Brazil
Recruiting
Xencor Investigative Site
Santo André, Brazil
Recruiting
Xencor Investigative Site
São Paulo, Brazil
Recruiting
Xencor Investigative Site
São Paulo, Brazil
Recruiting
Xencor Investigative Site
Votuporanga, Brazil
Recruiting
Xencor Investigative Site
Sofia, Bulgaria
Recruiting
Xencor Investigative Site
London, Canada
Recruiting
Xencor Investigative Site
Montreal, Canada
Recruiting
Xencor Investigative Site
Scarborough, Canada
Recruiting
Xencor Investigative Site
Vancouver, Canada
Recruiting
Xencor Investigative Site
Osijek, Croatia
Recruiting
Xencor Investigative Site
Rijeka, Croatia
Recruiting
Xencor Investigative Site
Zagreb, Croatia
Recruiting
Xencor Investigative Site
Tbilisi, Georgia
Recruiting
Showing 60 of 98 sites — filter to narrow it down. 96 of the 98 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06619990. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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