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Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
NCT06619990 · Xencor, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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 participants, will entail administration of XmAb942 or matching placebo at 3 different dose levels of XmAb942.
Part B: Repeat 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 24 week 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: 2029-01
Last updated: 2026-04-13
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
ContactSudeepta Aggarwal · contact · Xenith-UCinfo@xencor.com
ContactMark Osterman, MD, MSCE · contact · Xenith-UCinfo@xencor.com
InvestigatorMark Osterman, MD, MSCE · study_director, Xencor, Inc.
All locations (52)
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Scottsdale, Arizona, 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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Louisville, Kentucky, United States
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Raleigh, North Carolina, United States
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Denton, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Wollongong, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Southport, Queensland, Australia
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Joondalup, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Sofia, Bulgaria
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Rijeka, Croatia
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Zagreb, Croatia
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Tbilisi, Georgia
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Budapest, Hungary
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Vác, Hungary
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Chisinau, Moldova
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Wroclaw, Lower Silesian Voivodeship, Poland
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Warsaw, Mazonian, Poland
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Sopot, Pomeranian Voivodeship, Poland
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Bydgoszcz, Poland
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Katowice, Poland
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Staszów, Poland
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Szczecin, Poland
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Warsaw, Poland
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Bucharest, District 1, Romania
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Cluj-Napoca, Romania
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Lutsk, Volyn Oblast, Ukraine
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Ivano-Frankivsk, Ukraine
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Kyiv, Ukraine
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Kyiv, 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