Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Purpose
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).
Condition
- Ulcerative Colitis (UC)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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. |
|
|
Placebo Comparator 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. |
|
|
Active Comparator 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. |
|
|
Placebo Comparator 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. |
|
|
Active Comparator Part C: Active |
Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis |
|
|
Placebo Comparator Part C: placebo |
Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis |
|
Recruiting Locations
Scottsdale, Arizona 85255
Bradenton, Florida 34209
Brandon, Florida 33511
Jacksonville, Florida 32258
Kissimmee, Florida 34741
Margate, Florida 33063
Palmetto Bay, Florida 33176
Tampa, Florida 33612
Tampa, Florida 33613
Louisville, Kentucky 40218
Oxford, Mississippi 38655
Tupelo, Mississippi 38801
Albany, New York 12206
Rochester, New York 14618
Raleigh, North Carolina 27612
Beavercreek, Ohio 45440
Cordova, Tennessee 38018
Cedar Park, Texas 78613
Denton, Texas 76201
Garland, Texas 75044
Georgetown, Texas 78628
Houston, Texas 77024
Houston, Texas 77090
Kingwood, Texas 77339
Lubbock, Texas 79424
San Antonio, Texas 78229
Tyler, Texas 75701
Webster, Texas 77598
Richmond, Virginia 23229
More Details
- Status
- Recruiting
- Sponsor
- Xencor, Inc.
Detailed Description
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: 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 24 week follow-up period.