Recruiting
Phase 1
Phase 2

XmAb942

Sponsor:

Xencor, Inc.

Code:

NCT06619990

Conditions

Ulcerative Colitis (UC)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

XmAb942

Placebo

Study Details

Brief 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).

Conditions

Ulcerative Colitis (UC)

Study ID

NCT06619990

Start date

Oct 10, 2024

Status verified date

Jul, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

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.

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Part A: Active drug

Active XmAb942 to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels of XmAb942 via SC (3 cohorts) or IV (3 cohorts) administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.

placebo comparator: Part A: Placebo

Placebo Comparator to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels will be randomized in a 3:1 ratio to active or placebo.

active comparator: Part B: Active

Active XmAb942 to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels of XmAb942 via IV administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.

placebo comparator: Part B: Placebo

Placebo Comparator to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels will be randomized in a 3:1 ratio to active or placebo.

active comparator: Part C: Active

Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis

placebo comparator: Part C: placebo

Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis

Interventions

XmAb942

Antibody

Placebo

Placebo

Primary outcome measure

  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A) [ Time Frame: 20 weeks ]
  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B) [ Time Frame: 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. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

942 Study Information

Xenith-UCinfo@xencor.com

Locations

Xencor Investigative Site

Recruiting

Scottsdale, Arizona, United States, 85255

Xencor Investigative Site

Recruiting

Bradenton, Florida, United States, 34209

Xencor Investigative Site

Recruiting

Brandon, Florida, United States, 33511

Xencor Investigative Site

Recruiting

Jacksonville, Florida, United States, 32258

Xencor Investigative Site

Recruiting

Kissimmee, Florida, United States, 34741

Xencor Investigative Site

Recruiting

Margate, Florida, United States, 33063

Xencor Investigative Site

Recruiting

Palmetto Bay, Florida, United States, 33176

Xencor Investigative Site

Recruiting

Tampa, Florida, United States, 33612

Xencor Investigative Site

Recruiting

Tampa, Florida, United States, 33613

Xencor Investigative Site

Recruiting

Louisville, Kentucky, United States, 40218

Xencor Investigative Site

Recruiting

Oxford, Mississippi, United States, 38655

Xencor Investigative Site

Recruiting

Tupelo, Mississippi, United States, 38801

Xencor Investigative Site

Recruiting

Albany, New York, United States, 12206

Xencor Investigative Site

Recruiting

Rochester, New York, United States, 14618

Xencor Investigative Site

Recruiting

Raleigh, North Carolina, United States, 27612

Xencor Investigative Site

Recruiting

Beavercreek, Ohio, United States, 45440

Xencor Investigative Site

Recruiting

Cordova, Tennessee, United States, 38018

Xencor Investigative Site

Recruiting

Cedar Park, Texas, United States, 78613

Xencor Investigative Site

Recruiting

Denton, Texas, United States, 76201

Xencor Investigative Site

Recruiting

Garland, Texas, United States, 75044

Xencor Investigative Site

Recruiting

Georgetown, Texas, United States, 78628

Xencor Investigative Site

Recruiting

Houston, Texas, United States, 77024

Xencor Investigative Site

Recruiting

Houston, Texas, United States, 77090

Xencor Investigative Site

Recruiting

Kingwood, Texas, United States, 77339

Xencor Investigative Site

Recruiting

Lubbock, Texas, United States, 79424

Xencor Investigative Site

Recruiting

San Antonio, Texas, United States, 78229

Xencor Investigative Site

Recruiting

Tyler, Texas, United States, 75701

Xencor Investigative Site

Recruiting

Webster, Texas, United States, 77598

Xencor Investigative Site

Recruiting

Richmond, Virginia, United States, 23229

Xencor Investigative Site

Recruiting

London, Canada, N6K 1M5

Xencor Investigative Site

Recruiting

Montreal, Canada, H3H 1EB

Xencor Investigative Site

Recruiting

Scarborough, Canada, M1S4T7

Xencor Investigative Site

Recruiting

Vancouver, Canada, V6Z 2K5

More Information

Sponsor

Xencor, Inc.

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Ulcerative Colitis
  • Inflammatory Bowel Disease
  • Healthy Volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Xencor, Inc. on 2026-07-24.