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Clinical Trials in Australia / NCT06619990
Recruiting Phase 1/2

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

NCT06619990 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1/2
Started
2024-10-10
Last updated
2026-09-16

Condition(s) studied

Ulcerative Colitis (UC)

Investigational drug(s) / intervention(s)

XmAb942Placebo

XmAb942: Antibody

Placebo: Placebo

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (98)

FacilityCityRegionStatus
Xencor Investigative Site Scottsdale Arizona Recruiting
Xencor Investigative Site Palo Alto California Recruiting
Xencor Investigative Site Bradenton Florida Recruiting
Xencor Investigative Site Brandon Florida Recruiting
Xencor Investigative Site Jacksonville Florida Recruiting
Xencor Investigative Site Kissimmee Florida Recruiting
Xencor Investigative Site Margate Florida Recruiting
Xencor Investigative Site Palmetto Bay Florida Recruiting
Xencor Investigative Site Tampa Florida Recruiting
Xencor Investigative Site Tampa Florida Recruiting
Xencor Investigative Site Louisville Kentucky Recruiting
Xencor Investigative Site Oxford Mississippi Recruiting
Xencor Investigative Site Tupelo Mississippi Recruiting
Xencor Investigative Site Albany New York Recruiting
Xencor Investigative Site Rochester New York Recruiting
Xencor Investigative Site Raleigh North Carolina Recruiting
Xencor Investigative Site Beavercreek Ohio Recruiting
Xencor Investigative Site Cordova Tennessee Recruiting
Xencor Investigative Site Cedar Park Texas Recruiting
Xencor Investigative Site Denton Texas Recruiting
Xencor Investigative Site Garland Texas Recruiting
Xencor Investigative Site Georgetown Texas Recruiting
Xencor Investigative Site Houston Texas Recruiting
Xencor Investigative Site Houston Texas Recruiting
Xencor Investigative Site Kingwood Texas Recruiting
Xencor Investigative Site Lubbock Texas Recruiting
Xencor Investigative Site San Antonio Texas Recruiting
Xencor Investigative Site Tyler Texas Recruiting
Xencor Investigative Site Webster Texas Recruiting
Xencor Investigative Site Richmond Virginia Recruiting
Xencor Investigative Site Buenos Aires Argentina Recruiting
Xencor Investigative Site Buenos Aires Argentina Recruiting
Xencor Investigative Site Buenos Aires Argentina Recruiting
Xencor Investigative Site Rosario Argentina Recruiting
Xencor Investigative Site San Miguel de Tucumán Argentina Recruiting
Xencor Investigative Site Adelaide Australia Recruiting
Xencor Investigative Site Joondalup Australia Completed
Xencor Investigative Site Melbourne Australia Recruiting
Xencor Investigative Site Nedlands Australia Completed
Xencor Investigative Site South Brisbane Australia Recruiting

+ 58 more sites — see the full list on the official registry below.

More Xencor, Inc. trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619990 on ClinicalTrials.gov ↗ ← All trials in Australia