Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Xencor, Inc. · NCT06619990
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1, Phase 2
- Target enrollment
- 270
- US sites recruiting
- 30
- Study start
- October 10, 2024
- Record last updated
- September 29, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: XmAb942; Placebo
Conditions: Ulcerative Colitis (UC)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Xencor Investigative Site
Scottsdale, AZ 85255
Xencor Investigative Site
Palo Alto, CA 94301
Xencor Investigative Site
Bradenton, FL 34209
Xencor Investigative Site
Brandon, FL 33511
Xencor Investigative Site
Jacksonville, FL 32258
Xencor Investigative Site
Kissimmee, FL 34741
Xencor Investigative Site
Margate, FL 33063
Xencor Investigative Site
Palmetto Bay, FL 33176
Xencor Investigative Site
Tampa, FL 33612
Xencor Investigative Site
Tampa, FL 33613
Xencor Investigative Site
Louisville, KY 40218
Xencor Investigative Site
Oxford, MS 38655
Xencor Investigative Site
Tupelo, MS 38801
Xencor Investigative Site
Albany, NY 12206
Xencor Investigative Site
Rochester, NY 14618
Xencor Investigative Site
Raleigh, NC 27612
Xencor Investigative Site
Beavercreek, OH 45440
Xencor Investigative Site
Cordova, TN 38018
Xencor Investigative Site
Cedar Park, TX 78613
Xencor Investigative Site
Denton, TX 76201
Xencor Investigative Site
Garland, TX 75044
Xencor Investigative Site
Georgetown, TX 78628
Xencor Investigative Site
Houston, TX 77024
Xencor Investigative Site
Houston, TX 77090
Xencor Investigative Site
Kingwood, TX 77339
Xencor Investigative Site
Lubbock, TX 79424
Xencor Investigative Site
San Antonio, TX 78229
Xencor Investigative Site
Tyler, TX 75701
Xencor Investigative Site
Webster, TX 77598
Xencor Investigative Site
Richmond, VA 23229
Study contacts (from the official record)
- 942 Study Information · Xenith-UCinfo@xencor.com
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