RecruitingPhase 1Phase 2NCT06619990
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 in Participants With Moderate-To-Severe Active Ulcerative Colitis.
Sponsor
Xencor, Inc.
Enrollment
270 participants
Start Date
Oct 10, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Brief summary 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).
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria15
- 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 Criteria18
- 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
Interventions
BIOLOGICALXmAb942
Antibody
DRUGPlacebo
Placebo
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT06619990
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