Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

September 11, 2026 updated by: Xencor, Inc.

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.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study consists of 3 parts, as follows:

Part A: Single ascending dose (SAD) in healthy volunteer participants, will entail administration of XmAb942 or matching placebo at 3 different dose levels of XmAb942.

Part B: Multiple ascending dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo at 2 different dose levels of XmAb942.

Part C: Participants with moderately to severely active UC to receive 3 different dose levels of XmAb942 or placebo during a 12-week induction period and single dose level of XmAb942 during a 40-week maintenance period, followed by a 36 follow-up period.

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C425BGC
        • Recruiting
        • Xencor Investigative Site
      • Buenos Aires, Argentina, 1643
        • Recruiting
        • Xencor Investigative Site
      • Buenos Aires, Argentina, B1878
        • Recruiting
        • Xencor Investigative Site
      • Rosario, Argentina, S2000
        • Recruiting
        • Xencor Investigative Site
      • San Miguel de Tucumán, Argentina, 4000
        • Recruiting
        • Xencor Investigative Site
  • Australia
      • Adelaide, Australia, 5000
        • Recruiting
        • Xencor Investigative Site
      • Joondalup, Australia, 6027
        • Completed
        • Xencor Investigative Site
      • Melbourne, Australia, 3004
        • Recruiting
        • Xencor Investigative Site
      • Nedlands, Australia, 6009
        • Completed
        • Xencor Investigative Site
      • South Brisbane, Australia, 4101
        • Recruiting
        • Xencor Investigative Site
      • Southport, Australia, 4215
        • Recruiting
        • Xencor Investigative Site
      • Wollongong, Australia, 2500
        • Recruiting
        • Xencor Investigative Site
  • Brazil
      • Campinas, Brazil, 13092-133
        • Recruiting
        • Xencor Investigative Site
      • Fortaleza, Brazil, 60430-372
        • Recruiting
        • Xencor Investigative Site
      • Macaé, Brazil, 27 910-190
        • Recruiting
        • Xencor Investigative Site
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Xencor Investigative Site
      • Salvador, Brazil, 41 820-020
        • Recruiting
        • Xencor Investigative Site
      • Santo André, Brazil, 09080-110
        • Recruiting
        • Xencor Investigative Site
      • São Paulo, Brazil, 04543-011
        • Recruiting
        • Xencor Investigative Site
      • São Paulo, Brazil, 01307-000
        • Recruiting
        • Xencor Investigative Site
      • Votuporanga, Brazil, 15500-269
        • Recruiting
        • Xencor Investigative Site
  • Bulgaria
      • Sofia, Bulgaria, 1618
        • Recruiting
        • Xencor Investigative Site
  • Canada
      • London, Canada, N6K 1M5
        • Recruiting
        • Xencor Investigative Site
      • Montreal, Canada, H3H 1EB
        • Recruiting
        • Xencor Investigative Site
      • Scarborough, Canada, M1S4T7
        • Recruiting
        • Xencor Investigative Site
      • Vancouver, Canada, V6Z 2K5
        • Recruiting
        • Xencor Investigative Site
  • Croatia
      • Osijek, Croatia, 31000
        • Recruiting
        • Xencor Investigative Site
      • Rijeka, Croatia, 51000
        • Recruiting
        • Xencor Investigative Site
      • Zagreb, Croatia, 10000
        • Recruiting
        • Xencor Investigative Site
  • Georgia
      • Tbilisi, Georgia, 0112
        • Recruiting
        • Xencor Investigative Site
  • Greece
      • Athens, Greece, 10676
        • Recruiting
        • Xencor Investigative Site
      • Heraklion, Greece, 71500
        • Recruiting
        • Xencor Investigative Site
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Xencor Investigative Site
  • Hungary
      • Budapest, Hungary, 1136
        • Recruiting
        • Xencor Investigative Site
      • Budapest, Hungary, 1139
        • Recruiting
        • Xencor Investigative Site
      • Budapest, Hungary, 1066
        • Recruiting
        • Xencor Investigative Site
      • Nyíregyháza, Hungary, H-4405
        • Recruiting
        • Xencor Investigative Site
      • Vác, Hungary, 2600
        • Recruiting
        • Xencor Investigative Site
  • Moldova
      • Chisinau, Moldova
        • Recruiting
        • Xencor Investigative Site
  • Poland
      • Bydgoszcz, Poland, 85-079
        • Recruiting
        • Xencor Investigative Site
      • Katowice, Poland, 40-748
        • Recruiting
        • Xencor Investigative Site
      • Krakow, Poland, 30-363
        • Recruiting
        • Xencor Investigative Site
      • Nowy Targ, Poland, 34-400
        • Recruiting
        • Xencor Investigative Site
      • Sopot, Poland, 81-756
        • Recruiting
        • Xencor Investigative Site
      • Staszów, Poland, 28-200
        • Recruiting
        • Xencor Investigative Site
      • Szczecin, Poland, 71-685
        • Recruiting
        • Xencor Investigative Site
      • Warsaw, Poland, 004-501
        • Recruiting
        • Xencor Investigative Site
      • Warsaw, Poland, 00-189
        • Recruiting
        • Xencor Investigative Site
      • Warsaw, Poland, 03-580
        • Recruiting
        • Xencor Investigative Site
      • Wroclaw, Poland, 52-416
        • Recruiting
        • Xencor Investigative Site
      • Wroclaw, Poland, 53-611
        • Recruiting
        • Xencor Investigative Site
  • Portugal
      • Loures, Portugal, 2674-514
        • Recruiting
        • Xencor Investigative Site
  • Romania
      • Bragadiru, Romania, 400006
        • Recruiting
        • Xencor Investigative Site
      • Cluj-Napoca, Romania, 400006
        • Recruiting
        • Xencor Investigative Site
      • Ploieşti, Romania, 100032
        • Recruiting
        • Xencor Investigative Site
      • Timișoara, Romania, 300002
        • Recruiting
        • Xencor Investigative Site
    • District 1
      • Bucharest, District 1, Romania, 01-1658
        • Recruiting
        • Xencor Investigative Site
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Recruiting
        • Xencor Investigative Site
      • Kyiv, Ukraine, 01135
        • Recruiting
        • Xencor Investigative Site
      • Kyiv, Ukraine, 02091
        • Recruiting
        • Xencor Investigative Site
      • Lutsk, Ukraine, 43005
        • Recruiting
        • Xencor Investigative Site
      • Lviv, Ukraine, 79000
        • Recruiting
        • Xencor Investigative Site
      • Lviv, Ukraine, 79059
        • Recruiting
        • Xencor Investigative Site
      • Lviv, Ukraine, 79010
        • Recruiting
        • Xencor Investigative Site
      • Uzhhorod, Ukraine, 88000
        • Recruiting
        • Xencor Investigative Site
      • Vinnytsia, Ukraine, 21028
        • Recruiting
        • Xencor Investigative Site
      • Vinnytsia, Ukraine, 21009
        • Recruiting
        • Xencor Investigative Site
      • Zhytomyr, Ukraine, 10001
        • Recruiting
        • Xencor Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Recruiting
        • Xencor Investigative Site
    • California
      • Palo Alto, California, United States, 94301
        • Recruiting
        • Xencor Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Xencor Investigative Site
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Xencor Investigative Site
      • Jacksonville, Florida, United States, 32258
        • Recruiting
        • Xencor Investigative Site
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • Xencor Investigative Site
      • Margate, Florida, United States, 33063
        • Recruiting
        • Xencor Investigative Site
      • Palmetto Bay, Florida, United States, 33176
        • Recruiting
        • Xencor Investigative Site
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Xencor Investigative Site
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Xencor Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Recruiting
        • Xencor Investigative Site
    • Mississippi
      • Oxford, Mississippi, United States, 38655
        • Recruiting
        • Xencor Investigative Site
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Xencor Investigative Site
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • Xencor Investigative Site
      • Rochester, New York, United States, 14618
        • Recruiting
        • Xencor Investigative Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Xencor Investigative Site
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Recruiting
        • Xencor Investigative Site
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Xencor Investigative Site
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Recruiting
        • Xencor Investigative Site
      • Denton, Texas, United States, 76201
        • Recruiting
        • Xencor Investigative Site
      • Garland, Texas, United States, 75044
        • Recruiting
        • Xencor Investigative Site
      • Georgetown, Texas, United States, 78628
        • Recruiting
        • Xencor Investigative Site
      • Houston, Texas, United States, 77090
        • Recruiting
        • Xencor Investigative Site
      • Houston, Texas, United States, 77024
        • Recruiting
        • Xencor Investigative Site
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • Xencor Investigative Site
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • Xencor Investigative Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Xencor Investigative Site
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Xencor Investigative Site
      • Webster, Texas, United States, 77598
        • Recruiting
        • Xencor Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Recruiting
        • Xencor Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: XmAb942
Antibody
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.
Drug: Placebo
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.
Biological: XmAb942
Antibody
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.
Drug: Placebo
Placebo
Active Comparator: Part C: Active
Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
Biological: XmAb942
Antibody
Placebo Comparator: Part C: placebo
Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
A composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. It is calculated by adding the results from Mayo endoscopic subscore (MES) which measures GI bleeding, stool frequency subscore (SFS) which measures stool frequency per day, and rectal bleeding subscore (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)
Time Frame: up to 20 weeks
• Cmax (Maximum concentration of drug)
up to 20 weeks
Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)
Time Frame: up to 20 weeks
• AUC0-last (Area under the curve drug concentration-time curve to last concentration)
up to 20 weeks
Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)
Time Frame: up to 28 weeks
• Cmax (Maximum concentration of drug)
up to 28 weeks
Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)
Time Frame: up to 28 weeks
• AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal rule
up to 28 weeks
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) (Part C)
Time Frame: 72 weeks
72 weeks
Discontinuations due to TEAEs (Part C)
Time Frame: 72 weeks
72 weeks
Histological improvement as determined by change in Robarts Histopathology Index (RHI) scores, ranging from 0 (no disease activity) to 33 (severe disease activity).
Time Frame: 12 weeks
12 weeks
Endoscopic improvement defined as (MES) of 0 or 1 (Part C).
Time Frame: 12 weeks
12 weeks
Change from baseline in MS (Part C).
Time Frame: 12 weeks
12 weeks
Clinical response based on MMS score (Part C) defined as decrease from baseline in the MMS of ≥ 2 points and at least a 30% reduction from baseline, and decrease of ≥ 1 point in RBS from baseline or absolute RBS ≤ 1
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of XmAb942 on protein(s) and biomarkers
Time Frame: 28 weeks
Incidence and magnitude of drug induced antidrug antibodies (ADAs) and protein concentrations
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xencor, Inc.

Collaborators

Xencor, Inc.

Investigators

  • Study Director: 942 Study Information, Xencor, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XmAb942-01 (G942-101)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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