Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC)

In brief

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).

Key facts

Study ID

NCT06619990

Run by

Xencor, Inc.

People needed

270

Starts

2024-10-10

Expected to finish

2029-01-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Xencor Investigative Site — Bradenton, Florida, United States (enrolling)
• Xencor Investigative Site — Brandon, Florida, United States (enrolling)
• Xencor Investigative Site — Jacksonville, Florida, United States (enrolling)
• Xencor Investigative Site — Kissimmee, Florida, United States (enrolling)
• Xencor Investigative Site — Margate, Florida, United States (enrolling)
• Xencor Investigative Site — Palmetto Bay, Florida, United States (enrolling)
• Xencor Investigative Site — Tampa, Florida, United States (enrolling)
• Xencor Investigative Site — Tampa, Florida, United States (enrolling)
• Xencor Investigative Site — Louisville, Kentucky, United States (enrolling)
• Xencor Investigative Site — Oxford, Mississippi, United States (enrolling)
• Xencor Investigative Site — Tupelo, Mississippi, United States (enrolling)
• Xencor Investigative Site — Albany, New York, United States (enrolling)
• Xencor Investigative Site — Rochester, New York, United States (enrolling)
• Xencor Investigative Site — Raleigh, North Carolina, United States (enrolling)
• Xencor Investigative Site — Beavercreek, Ohio, United States (enrolling)
• Xencor Investigative Site — Cordova, Tennessee, United States (enrolling)
• Xencor Investigative Site — Cedar Park, Texas, United States (enrolling)
• Xencor Investigative Site — Denton, Texas, United States (enrolling)
• Xencor Investigative Site — Garland, Texas, United States (enrolling)
• Xencor Investigative Site — Georgetown, Texas, United States (enrolling)
• Xencor Investigative Site — Houston, Texas, United States (enrolling)
• Xencor Investigative Site — Houston, Texas, United States (enrolling)
• Xencor Investigative Site — Kingwood, Texas, United States (enrolling)
• Xencor Investigative Site — Lubbock, Texas, United States (enrolling)
• Xencor Investigative Site — Scottsdale, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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