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.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests XmAb942 in healthy adults in Parts A and B and in adults with ulcerative colitis in Part C. Ulcerative colitis causes swelling and sores in the large bowel. The study looks at safety and how the drug acts in the body; other study rules also apply.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- All parts: Be in good health with no major medical history, and be able and willing to sign a consent form.
- Parts A and B: Be 18–55 years old.
- Parts A and B: Have normal lab results and a BMI of 18–35. BMI measures weight compared with height.
- Parts A and B: Follow local birth control rules.
- Part C: Be 18–75 years old and have had a ulcerative colitis diagnosis for at least 3 months before screening.
- Part C: Have moderate to severe active ulcerative colitis that meets the study’s required disease scores.
- Part C: A colonoscopy, a test using a camera inside the bowel, must show colitis reaching at least 15 cm from the opening of the anus.
- Part C: Have tried at least one ulcerative colitis treatment that did not work well enough, stopped working, or caused side effects you could not tolerate.
Who can't join
- All parts: Have a physical or mental health condition that would prevent taking part or finishing the study.
- All parts: Test positive for HIV, hepatitis B, or hepatitis C; have an abnormal heart rhythm; or have an important abnormal result on an ECG, a heart tracing test.
- All parts: Be pregnant or breastfeeding.
- Parts A and B: Have a history of suicidal thoughts or behavior, or heavy use of products with nicotine.
- Parts A and B: Use prescription drugs within 14 days before study Day -1, or nonprescription or herbal medicines within 7 days before screening.
- Parts A and B: Use another study treatment within 30 days, or donate blood or plasma within 60 days.
- Part C: Have Crohn’s disease or another listed type of colitis, including an unclear type, microscopic colitis, or colitis linked to poor blood flow, infection, radiation, or bowel pouches.
- Part C: Test positive for toxins from C. difficile, a germ that can cause bowel infection.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (30)
AZ
- Xencor Investigative Site · Scottsdale, AZ 85255More trials in Scottsdale
CA
- Xencor Investigative Site · Palo Alto, CA 94301More trials in Palo Alto
FL
- Xencor Investigative Site · Bradenton, FL 34209More trials in Bradenton
- Xencor Investigative Site · Brandon, FL 33511More trials in Brandon
- Xencor Investigative Site · Jacksonville, FL 32258More trials in Jacksonville
- Xencor Investigative Site · Kissimmee, FL 34741More trials in Kissimmee
- Xencor Investigative Site · Margate, FL 33063More trials in Margate
- Xencor Investigative Site · Palmetto Bay, FL 33176More trials in Palmetto Bay
- Xencor Investigative Site · Tampa, FL 33612More trials in Tampa
- Xencor Investigative Site · Tampa, FL 33613More trials in Tampa
KY
- Xencor Investigative Site · Louisville, KY 40218More trials in Louisville
MS
- Xencor Investigative Site · Oxford, MS 38655More trials in Oxford
- Xencor Investigative Site · Tupelo, MS 38801More trials in Tupelo
NC
- Xencor Investigative Site · Raleigh, NC 27612More trials in Raleigh
NY
- Xencor Investigative Site · Albany, NY 12206More trials in Albany
- Xencor Investigative Site · Rochester, NY 14618More trials in Rochester
OH
- Xencor Investigative Site · Beavercreek, OH 45440More trials in Beavercreek
TN
- Xencor Investigative Site · Cordova, TN 38018More trials in Cordova
TX
- Xencor Investigative Site · Cedar Park, TX 78613More trials in Cedar Park
- Xencor Investigative Site · Denton, TX 76201More trials in Denton
- Xencor Investigative Site · Garland, TX 75044More trials in Garland
- Xencor Investigative Site · Georgetown, TX 78628More trials in Georgetown
- Xencor Investigative Site · Houston, TX 77024More trials in Houston
- Xencor Investigative Site · Houston, TX 77090More trials in Houston
- Xencor Investigative Site · Kingwood, TX 77339More trials in Kingwood
- Xencor Investigative Site · Lubbock, TX 79424More trials in Lubbock
- Xencor Investigative Site · San Antonio, TX 78229More trials in San Antonio
- Xencor Investigative Site · Tyler, TX 75701More trials in Tyler
- Xencor Investigative Site · Webster, TX 77598More trials in Webster
VA
- Xencor Investigative Site · Richmond, VA 23229More trials in Richmond