Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Recruiting now Phase 1/2 NCT06619990
Run by Xencor, Inc. · for 18 to 75 · All sexes · accepts healthy volunteers
What this study is about
Brief summary 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).
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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.
Where this trial is running
- Xencor Investigative Site, Scottsdale, Arizona, United States
- Xencor Investigative Site, Bradenton, Florida, United States
- Xencor Investigative Site, Brandon, Florida, United States
- Xencor Investigative Site, Jacksonville, Florida, United States
- Xencor Investigative Site, Kissimmee, Florida, United States
- Xencor Investigative Site, Margate, Florida, United States
- Xencor Investigative Site, Palmetto Bay, Florida, United States
- Xencor Investigative Site, Tampa, Florida, United States
- Xencor Investigative Site, Louisville, Kentucky, United States
- Xencor Investigative Site, Albany, New York, United States
- Xencor Investigative Site, Rochester, New York, United States
- Xencor Investigative Site, Raleigh, North Carolina, United States
+ 54 more sites.
Who to contact
Sudeepta Aggarwal · Xenith-UCinfo@xencor.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06619990.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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