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NCT06619990RecruitingPhase 1/2

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

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.

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
270 (estimated)
First submitted
20 Sept 2024
Start date
10 Oct 2024
Primary completion date
31 Dec 2027
Lead sponsor
Xencor, Inc.
NCT number
NCT06619990

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 270
  • From 10 Oct 2024 to the primary completion date, 31 Dec 2027
  • 94 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Any physical or psychological condition that prohibits study completion
  • History of suicidal behavior or suicidal ideation
  • HIV, hepatitis B and hepatitis C positive
  • Cardiac arrhythmia, or clinically significant abnormal ECG
  • 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.
  • HIV, hepatitis B and hepatitis C positive
  • Cardiac arrhythmia, or clinically significant abnormal ECG

Other

  • Parts A and B
  • Heavy use of nicotine containing products
  • Blood or plasma donation within 60 days
  • Pregnant or breastfeeding
    • Part C
  • Positive screen for Clostridium difficile (C. Difficile) toxins
  • Pregnant or breastfeeding
    • Other protocol defined inclusion/exclusion criteria apply.

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (94)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xencor Investigative Site
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Buenos AiresArgentinaRecruiting
Xencor Investigative Site
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RosarioArgentinaRecruiting
Xencor Investigative Site
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San Miguel de TucumánArgentinaRecruiting
Xencor Investigative Site
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AdelaideAustraliaRecruiting
Xencor Investigative Site
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BrisbaneAustraliaRecruiting
Xencor Investigative Site
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JoondalupAustraliaCompleted
Xencor Investigative Site
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Macquarie ParkAustraliaRecruiting
Xencor Investigative Site
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MelbourneAustraliaRecruiting
Xencor Investigative Site
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NedlandsAustraliaCompleted
Xencor Investigative Site
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South BrisbaneAustraliaRecruiting
Xencor Investigative Site
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SouthportAustraliaRecruiting
Xencor Investigative Site
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WollongongAustraliaRecruiting
Xencor Investigative Site
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SofiaBulgariaRecruiting
Xencor Investigative Site
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CampinasBrazilRecruiting
Xencor Investigative Site
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Caxias do SulBrazilRecruiting
Xencor Investigative Site
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FortalezaBrazilRecruiting
Xencor Investigative Site
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MacaéBrazilRecruiting
Xencor Investigative Site
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Porto AlegreBrazilRecruiting
Xencor Investigative Site
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SalvadorBrazilRecruiting
Xencor Investigative Site
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Santo AndréBrazilRecruiting
Xencor Investigative Site
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São PauloBrazilRecruiting
Xencor Investigative Site
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VotuporangaBrazilRecruiting
Xencor Investigative Site
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LondonCanadaRecruiting
Xencor Investigative Site
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MontrealCanadaRecruiting
Xencor Investigative Site
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ScarboroughCanadaRecruiting
Xencor Investigative Site
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VancouverCanadaRecruiting
Xencor Investigative Site
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SantiagoChileRecruiting
Xencor Investigative Site
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BarcelonaSpainRecruiting
Xencor Investigative Site
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ValenciaSpainRecruiting
Xencor Investigative Site
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TbilisiGeorgiaRecruiting
Xencor Investigative Site
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AthensGreeceRecruiting
Xencor Investigative Site
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HeraklionGreeceRecruiting
Xencor Investigative Site
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ThessalonikiGreeceRecruiting
Xencor Investigative Site
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OsijekCroatiaRecruiting
Xencor Investigative Site
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RijekaCroatiaRecruiting
Xencor Investigative Site
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ZagrebCroatiaRecruiting
Xencor Investigative Site
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BudapestHungaryRecruiting
Xencor Investigative Site
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NyíregyházaHungaryRecruiting
Xencor Investigative Site
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VácHungaryRecruiting
Xencor Investigative Site
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AmmanJordanRecruiting
Xencor Investigative Site
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IrbidJordanRecruiting
Xencor Investigative Site
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BeirutLebanonRecruiting
Xencor Investigative Site
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TripoliLebanonRecruiting
Xencor Investigative Site
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ChisinauMoldovaRecruiting
Xencor Investigative Site
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BydgoszczPolandRecruiting
Xencor Investigative Site
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KatowicePolandRecruiting
Xencor Investigative Site
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KrakowPolandRecruiting
Xencor Investigative Site
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Nowy TargPolandRecruiting
Xencor Investigative Site
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SopotPolandRecruiting
Xencor Investigative Site
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StaszówPolandRecruiting
Xencor Investigative Site
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SzczecinPolandRecruiting
Xencor Investigative Site
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WarsawPolandRecruiting
Xencor Investigative Site
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WroclawPolandRecruiting
Xencor Investigative Site
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LouresPortugalRecruiting
Xencor Investigative Site
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BragadiruRomaniaRecruiting
Xencor Investigative Site
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BucharestRomaniaRecruiting
Xencor Investigative Site
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Cluj-NapocaRomaniaRecruiting
Xencor Investigative Site
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PloieştiRomaniaRecruiting
Xencor Investigative Site
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TimișoaraRomaniaRecruiting
Xencor Investigative Site
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Ivano-FrankivskUkraineRecruiting
Xencor Investigative Site
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KyivUkraineRecruiting
Xencor Investigative Site
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LutskUkraineRecruiting
Xencor Investigative Site
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LvivUkraineRecruiting
Xencor Investigative Site
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UzhhorodUkraineRecruiting
Xencor Investigative Site
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VinnytsiaUkraineRecruiting
Xencor Investigative Site
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ZhytomyrUkraineRecruiting
Xencor Investigative Site
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AlbanyUnited StatesRecruiting
Xencor Investigative Site
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BeavercreekUnited StatesRecruiting
Xencor Investigative Site
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BradentonUnited StatesRecruiting
Xencor Investigative Site
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BrandonUnited StatesRecruiting
Xencor Investigative Site
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Cedar ParkUnited StatesRecruiting
Xencor Investigative Site
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CordovaUnited StatesRecruiting
Xencor Investigative Site
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DentonUnited StatesRecruiting
Xencor Investigative Site
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GarlandUnited StatesRecruiting
Xencor Investigative Site
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GeorgetownUnited StatesRecruiting
Xencor Investigative Site
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HoustonUnited StatesRecruiting
Xencor Investigative Site
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JacksonvilleUnited StatesRecruiting
Xencor Investigative Site
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KingwoodUnited StatesRecruiting
Xencor Investigative Site
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KissimmeeUnited StatesRecruiting
Xencor Investigative Site
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LouisvilleUnited StatesRecruiting
Xencor Investigative Site
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LubbockUnited StatesRecruiting
Xencor Investigative Site
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MargateUnited StatesRecruiting
Xencor Investigative Site
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OxfordUnited StatesRecruiting
Xencor Investigative Site
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Palmetto BayUnited StatesRecruiting
Xencor Investigative Site
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Palo AltoUnited StatesRecruiting
Xencor Investigative Site
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RaleighUnited StatesRecruiting
Xencor Investigative Site
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RichmondUnited StatesRecruiting
Xencor Investigative Site
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RochesterUnited StatesRecruiting
Xencor Investigative Site
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San AntonioUnited StatesRecruiting
Xencor Investigative Site
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ScottsdaleUnited StatesRecruiting
Xencor Investigative Site
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TampaUnited StatesRecruiting
Xencor Investigative Site
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TupeloUnited StatesRecruiting
Xencor Investigative Site
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TylerUnited StatesRecruiting
Xencor Investigative Site
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WebsterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.