Back to search results

Study of XmAb942 for Ulcerative Colitis

This study is testing a new antibody called XmAb942. It has three parts. Parts A and B are for healthy volunteers aged 18-55 to check the safety and how the body handles XmAb942. Part C is for people aged 18-75 with moderately to severely active ulcerative colitis (UC) to see if XmAb942 can help them achieve clinical remission. Clinical remission means your symptoms, like rectal bleeding and frequent stools, are significantly reduced. The study aims to enroll 270 participants in total. The current status of the study is unclear.

Study design
This interventional study has three parts, testing different doses of XmAb942 or a placebo. It plans to enroll 270 participants.
What's involved
Part C participants with UC will receive XmAb942 or placebo for 12 weeks, followed by a 40-week maintenance period.
Compensation
Not stated in the trial record.
Follow-up
Participants in Part C will have a 24-week follow-up period after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06619990

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Xencor, Inc.
~270 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:XmAb942Placebo

At a glance

Recruiting sites
88 of 90 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A)
Measured over 20 weeks
+2 more outcomes measured

Conditions

Ulcerative Colitis (UC)

Explore related trials

Healthy VolunteerUlcerative Colitis

Where it's being run

90 sites across 25 states
Poland12
Texas11
Ukraine11
Florida8
Australia7
Brazil5
Hungary5
Canada4

Study leadership

  • 942 Study Information · STUDY_DIRECTOR · Xencor, Inc.

Who to contact

942 Study Information
[email protected]
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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

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
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

What this trial measures

  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A)20 weeks
  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B)28 weeks
  • Clinical remission based on modified mayo score (MMS), defined as MMS ≤ 2 with Mayo endoscopic score (MES) of 1, rectal bleeding subscore (RBS) of 0, and stool frequency subscore (SFS) of 0-1.12 weeks

    A composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. It is calculated by adding the results from Mayo endoscopic subscore (MES) which measures GI bleeding, stool frequency subscore (SFS) which measures stool frequency per day, and rectal bleeding subscore (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.