Tests XmAb942 in healthy people, then in people with ulcerative colitis
Tests XmAb942 safety in healthy adults, then its effect in ulcerative colitis.
Key facts
- Who runs it
- Xencor, Inc.
- Where
- Sofia, BulgariaSee the siteAlso in 18 other countries, 93 sites
- Trial code
- Registry title
- Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 270 people, planned
- Started
- 10 Oct 2024
- Expected to end
- May 2030
- Type of study
- Interventional, 6 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- XmAb942
- Placebo
- Record updated
- 30 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults (Parts A and B) and adults with moderate-to-severe active ulcerative colitis (Part C) to test the safety and effect of XmAb942.
- Age
- Parts A and B: 18-55 years. Part C: 18-75 years.
- Sex
- All sexes can join.
- Disease stage
- Part C: ulcerative colitis diagnosed at least 3 months before screening, moderately to severely active (MMS ≥ 5, with a MES ≥ 2 and RBS ≥ 1). Colitis must extend ≥ 15 cm (5.9 in) from the anal verge on colonoscopy.
- Earlier treatment
- Part C: inadequate response to, loss of response to, or intolerance to at least 1 conventional or advanced therapy for ulcerative colitis.
Main reasons for not taking part
- Crohn disease, indeterminate colitis, or other types of colitis (Part C)
- Positive test for Clostridium difficile toxins (Part C)
- HIV, hepatitis B or hepatitis C positive
- Pregnant or breastfeeding
- Heart rhythm problem or clinically significant abnormal ECG
The registry criteria, word for word
Show all 31 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Any physical or psychological condition that prohibits study completion
- History of suicidal behavior or suicidal ideation
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
- 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
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
- Parts A and B
- Heavy use of nicotine containing products
- Blood or plasma donation within 60 days
- Pregnant or breastfeeding; Part C
- Positive screen for Clostridium difficile (C. Difficile) toxins
- Pregnant or breastfeeding; Other protocol defined inclusion/exclusion criteria apply
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Bulgaria
Also in 18 other countries, 93 sites
- SofiaHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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).
The 6 groups in the trial
- Part A: Active drugExisting treatment, for comparison
Active XmAb942 to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels of XmAb942 via SC (3 cohorts) or IV (3 cohorts) administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.
Treatment: XmAb942
- Part A: PlaceboPlacebo, for comparison
Placebo Comparator to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels will be randomized in a 3:1 ratio to active or placebo.
Treatment: Placebo
- Part B: ActiveExisting treatment, for comparison
Active XmAb942 to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels of XmAb942 via IV administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.
Treatment: XmAb942
- Part B: PlaceboPlacebo, for comparison
Placebo Comparator to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels will be randomized in a 3:1 ratio to active or placebo.
Treatment: Placebo
- Part C: ActiveExisting treatment, for comparison
Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
Treatment: XmAb942
- Part C: placeboPlacebo, for comparison
Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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.
- Plain-language title
- Tests XmAb942 in healthy people, then in people with ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06619990, who can take part
- Record updated
- 30 October 2026