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Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

NCT06619990 · Xencor, Inc.
In plain English

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Official title
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.
About this study
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.
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.
Study design
Enrollment target: 270 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-10-10
Estimated completion: 2030-05
Last updated: 2026-09-16
Interventions
Biological: XmAb942Drug: Placebo
Primary outcomes
  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A) (20 weeks)
  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B) (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. (12 weeks)
Sponsor
Xencor, Inc. · industry
Contacts & investigators
Contact942 Study Information · contact · Xenith-UCinfo@xencor.com
Investigator942 Study Information · study_director, Xencor, Inc.
All locations (98)
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Scottsdale, Arizona, United States
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Palo Alto, California, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Margate, Florida, United States
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Palmetto Bay, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Louisville, Kentucky, United States
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Oxford, Mississippi, United States
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Tupelo, Mississippi, United States
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Albany, New York, United States
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Rochester, New York, United States
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Raleigh, North Carolina, United States
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Beavercreek, Ohio, United States
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Cordova, Tennessee, United States
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Cedar Park, Texas, United States
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Denton, Texas, United States
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Garland, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Webster, Texas, United States
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Richmond, Virginia, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Adelaide, Australia
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Joondalup, Australia
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Melbourne, Australia
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Nedlands, Australia
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South Brisbane, Australia
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Southport, Australia
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Wollongong, Australia
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Campinas, Brazil
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Fortaleza, Brazil
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Macaé, Brazil
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Porto Alegre, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Votuporanga, Brazil
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Sofia, Bulgaria
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London, Canada
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Montreal, Canada
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Scarborough, Canada
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Vancouver, Canada
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Osijek, Croatia
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Rijeka, Croatia
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Zagreb, Croatia
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Tbilisi, Georgia
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Athens, Greece
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Heraklion, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Nyíregyháza, Hungary
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Vác, Hungary
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Chisinau, Moldova
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Bydgoszcz, Poland
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Katowice, Poland
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Krakow, Poland
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Nowy Targ, Poland
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Sopot, Poland
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Staszów, Poland
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Szczecin, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Loures, Portugal
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Bucharest, District 1, Romania
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Bragadiru, Romania
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Cluj-Napoca, Romania
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Ploieşti, Romania
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Timișoara, Romania
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Ivano-Frankivsk, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Lviv, Ukraine
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Lviv, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine
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Vinnytsia, Ukraine
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Zhytomyr, Ukraine