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Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

RecruitingPhase 1/2Healthy volunteers welcome

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

Ages 18 to 75 · All sexes · Healthy volunteers welcome

Full 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.

About the study

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).

What is being tested

Sponsor: Xencor, Inc. · Participants: 270 · Started: Oct 10, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06619990

Locations in the U.S.

ArizonaXencor Investigative Site, Scottsdale
CaliforniaXencor Investigative Site, Palo Alto
FloridaXencor Investigative Site, Bradenton
Xencor Investigative Site, Brandon
Xencor Investigative Site, Jacksonville
Xencor Investigative Site, Kissimmee
Xencor Investigative Site, Margate
Xencor Investigative Site, Palmetto Bay
Xencor Investigative Site, Tampa
Xencor Investigative Site, Tampa
KentuckyXencor Investigative Site, Louisville
MississippiXencor Investigative Site, Oxford
Xencor Investigative Site, Tupelo
New YorkXencor Investigative Site, Albany
Xencor Investigative Site, Rochester
North CarolinaXencor Investigative Site, Raleigh
OhioXencor Investigative Site, Beavercreek
TennesseeXencor Investigative Site, Cordova
TexasXencor Investigative Site, Cedar Park
Xencor Investigative Site, Denton
Xencor Investigative Site, Garland
Xencor Investigative Site, Georgetown
Xencor Investigative Site, Houston
Xencor Investigative Site, Houston
Xencor Investigative Site, Kingwood
Xencor Investigative Site, Lubbock
Xencor Investigative Site, San Antonio
Xencor Investigative Site, Tyler
Xencor Investigative Site, Webster
VirginiaXencor Investigative Site, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.