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Evaluating XmAb942 in Healthy Individuals and Those 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 in Participants With Moderate-To-Severe Active Ulcerative Colitis.

PHASE1; PHASE2 · Xencor, Inc. · NCT06619990

This study is testing a new drug called XmAb942 in healthy people and those with ulcerative colitis to see how safe it is and how well it works.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment270 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorXencor, Inc. (industry)
Drugs / interventionsradiation
Locations57 sites (Scottsdale, Arizona and 56 other locations)
Trial IDNCT06619990 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of XmAb942 through a three-part approach. The first two parts involve healthy volunteers receiving single and multiple doses of XmAb942 or a placebo. The third part focuses on participants with Ulcerative Colitis, who will receive the determined dose of XmAb942 or placebo based on the results from the healthy volunteer phases. The study is designed to assess both the drug's effects and its safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-55 with a diagnosis of Ulcerative Colitis and no significant medical history.

Not a fit: Patients with severe underlying health conditions or those with a history of suicidal behavior may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with Ulcerative Colitis.

How similar studies have performed: Other studies have shown promise with similar approaches in treating Ulcerative Colitis, but the specific use of XmAb942 is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Scottsdale, Arizona and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ulcerative Colitis, Inflammatory Bowel Disease, Healthy Volunteers

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.