Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
NCT ID: NCT06619990
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
270 participants
INTERVENTIONAL
2024-10-10
2029-01-31
Brief Summary
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Detailed Description
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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 40-week maintenance period, followed by a 24 week follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
XmAb942
Antibody
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.
Placebo
Placebo
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.
XmAb942
Antibody
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.
Placebo
Placebo
Part C: Active
Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
XmAb942
Antibody
Part C: placebo
Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis
Placebo
Placebo
Interventions
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XmAb942
Antibody
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 modified Mayo score (MMS) of ≥ 5, with a Mayo endoscopic subscore (ES) of ≥ 2 and rectal bleeding subscore ≥ 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Xencor, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Osterman, MD, MSCE
Role: STUDY_DIRECTOR
Xencor, Inc.
Locations
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Clinical Research of Osceola
Kissimmee, Florida, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Master Misericordiae Ltd
South Brisbane, Queensland, Australia
Linear Clinical Research
Joondalup, Western Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Countries
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Central Contacts
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Other Identifiers
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XmAb942-01 (G942-101)
Identifier Type: -
Identifier Source: org_study_id
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