Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Recruiting · NCT06619990 · Interventional (participants receive a specific treatment) · Lead sponsor: Xencor, Inc.

View the official record on ClinicalTrials.gov →

Interventions studied

PlaceboXmAb942

What this trial is about

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).

Who can take part

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Phase 1, Phase 2

Study type

Interventional (participants receive a specific treatment)

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
ther protocol defined inclusion/exclusion criteria apply.

Where it is running

60 locations listed across 11 US states.

Xencor Investigative Site - Scottsdale, Arizona, United States
Xencor Investigative Site - Palo Alto, California, United States
Xencor Investigative Site - Bradenton, Florida, United States
Xencor Investigative Site - Brandon, Florida, United States
Xencor Investigative Site - Jacksonville, Florida, United States
Xencor Investigative Site - Kissimmee, Florida, United States
Xencor Investigative Site - Margate, Florida, United States
Xencor Investigative Site - Palmetto Bay, Florida, United States
Xencor Investigative Site - Tampa, Florida, United States
Xencor Investigative Site - Tampa, Florida, United States
Xencor Investigative Site - Louisville, Kentucky, United States
Xencor Investigative Site - Oxford, Mississippi, United States
Xencor Investigative Site - Tupelo, Mississippi, United States
Xencor Investigative Site - Albany, New York, United States
Xencor Investigative Site - Rochester, New York, United States
Xencor Investigative Site - Raleigh, North Carolina, United States
Xencor Investigative Site - Beavercreek, Ohio, United States
Xencor Investigative Site - Cordova, Tennessee, United States
Xencor Investigative Site - Cedar Park, Texas, United States
Xencor Investigative Site - Denton, Texas, United States
Xencor Investigative Site - Garland, Texas, United States
Xencor Investigative Site - Georgetown, Texas, United States
Xencor Investigative Site - Houston, Texas, United States
Xencor Investigative Site - Houston, Texas, United States
Xencor Investigative Site - Kingwood, Texas, United States
Xencor Investigative Site - Lubbock, Texas, United States
Xencor Investigative Site - San Antonio, Texas, United States
Xencor Investigative Site - Tyler, Texas, United States
Xencor Investigative Site - Webster, Texas, United States
Xencor Investigative Site - Richmond, Virginia, United States
Xencor Investigative Site - Adelaide, Australia
Xencor Investigative Site - Athens, Greece
Xencor Investigative Site - Bragadiru, Romania
Xencor Investigative Site - Budapest, Hungary
Xencor Investigative Site - Budapest, Hungary
Xencor Investigative Site - Budapest, Hungary
Xencor Investigative Site - Buenos Aires, Argentina
Xencor Investigative Site - Buenos Aires, Argentina
Xencor Investigative Site - Buenos Aires, Argentina
Xencor Investigative Site - Bydgoszcz, Poland
Xencor Investigative Site - Campinas, Brazil
Xencor Investigative Site - Chisinau, Moldova
Xencor Investigative Site - Cluj-Napoca, Romania
Xencor Investigative Site - Fortaleza, Brazil
Xencor Investigative Site - Heraklion, Greece
Xencor Investigative Site - Ivano-Frankivsk, Ukraine
Xencor Investigative Site - Joondalup, Australia
Xencor Investigative Site - Katowice, Poland
Xencor Investigative Site - Krakow, Poland
Xencor Investigative Site - Kyiv, Ukraine
Xencor Investigative Site - Kyiv, Ukraine
Xencor Investigative Site - London, Canada
Xencor Investigative Site - Loures, Portugal
Xencor Investigative Site - Lutsk, Ukraine
Xencor Investigative Site - Lviv, Ukraine
Xencor Investigative Site - Lviv, Ukraine
Xencor Investigative Site - Lviv, Ukraine
Xencor Investigative Site - Macaé, Brazil
Xencor Investigative Site - Melbourne, Australia
Xencor Investigative Site - Montreal, Canada

Showing 60 of 98 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →