Ulcerative Colitis (UC)
XmAb942 in Healthy Adults and Adults With Active Ulcerative Colitis
This randomized study evaluates XmAb942 or placebo in healthy adults and adults with moderate-to-severe active ulcerative colitis, examining safety, drug behavior, biological effects, and ulcerative colitis outcomes.
Registry title: Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
29 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- XmAb942 or Placebo
- Design
- Randomized · Double
- Central study contact
- 942 Study InformationXenith-UCinfo@xencor.com
- Sponsor
- Xencor, Inc.
Research question
What are the safety, tolerability, drug-concentration, biological-effect, and ulcerative colitis outcomes of XmAb942 compared with placebo across the study's healthy-participant and ulcerative-colitis parts?
Participant snapshot
Who the study is looking for
- Parts A and B are looking for healthy adults ages 18 to 55 with no significant medical history.
- Part C is looking for adults ages 18 to 75 whose ulcerative colitis was diagnosed at least three months before screening.
- Part C requires moderate-to-severe active ulcerative colitis based on specified Mayo score, endoscopy, rectal bleeding, and disease-extent findings.
- Part C is looking for people who had an inadequate response, lost response, or were intolerant to at least one conventional or advanced ulcerative colitis therapy.
Participation overview
What participation may involve
Healthy participants in Parts A and B receive XmAb942 or placebo in single- or multiple-ascending-dose groups. Participants with ulcerative colitis in Part C receive XmAb942 or placebo during induction, followed by an XmAb942 maintenance period and follow-up. What participation may involve: - Part A involves one administration of XmAb942 or placebo; XmAb942 may be given subcutaneously or intravenously. - Part B involves multiple administrations—up to three doses—of XmAb942 or placebo, with XmAb942 given intravenously. - Part C includes a 12-week induction period with three XmAb942 dose levels or placebo, a 40-week maintenance period using one XmAb942 dose level, and a 24-week follow-up. - The study assesses adverse events; drug concentrations are assessed in healthy participants, and clinical, endoscopic, and tissue-based disease outcomes are assessed in Part C. For Part C, the registry reports a 12-week induction period, a 40-week maintenance period, and a 24-week follow-up period. It does not explicitly state total participation durations for Parts A and B.
Study interventions
What participants may receive or do
- XmAb942: The registry describes XmAb942 as an antibody. Healthy participants receive single or multiple ascending doses, while Part C evaluates three dose levels during induction and one dose level during maintenance.
- Placebo: Some participants receive a matching placebo for comparison with XmAb942. The registry does not describe the placebo's contents.
Study design
How the comparison works
This Phase 1 and Phase 2 interventional study has parallel XmAb942 and placebo groups. Parts A and B evaluate ascending doses in healthy participants, and Part C evaluates XmAb942 in people with moderate-to-severe active ulcerative colitis. Participants are assigned randomly to parallel study groups. Parts A and B use a 3:1 assignment ratio to XmAb942 or placebo; the Part C assignment ratio is not reported. The study is double-blind: the registry states that participants and investigators are masked to assigned treatment. Placebo groups provide the comparison for the XmAb942 groups in all three study parts. A matching placebo is used. Parts A and B report a 3:1 XmAb942-to-placebo assignment ratio, but the record does not report the placebo probability for Part C.
Reported activities
Procedures and tests
- Screening for Part C includes confirmation by colonoscopy that ulcerative colitis extends at least 15 centimeters from the anal verge.
- Ulcerative colitis activity is assessed using the modified Mayo score, including endoscopy, rectal bleeding, and stool-frequency subscores.
- Endoscopic improvement is assessed using the Mayo endoscopic score at 12 weeks in Part C.
- Tissue-level improvement is assessed at 12 weeks using the Robarts Histopathology Index.
- Blood serum is assessed for XmAb942 pharmacokinetic measures, including maximum drug concentration and drug exposure over time, in Parts A and B.
- Treatment-emergent adverse events and serious adverse events are monitored in all three study parts.
- Screening criteria include clinical laboratory values for Parts A and B, electrocardiogram findings, and tests for human immunodeficiency virus and hepatitis B and C.
- Part C screening includes a test for Clostridium difficile toxins.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Parts A and B require participants to be ages 18 to 55.
- Parts A and B require good health, no significant medical history, normal clinical laboratory values, and a body mass index from 18 through 35.
- Part C requires participants to be ages 18 to 75.
- Part C requires an ulcerative colitis diagnosis made at least three months before screening.
- Part C requires moderate-to-severe active ulcerative colitis, defined as a modified Mayo score of at least 5, a Mayo endoscopic score of at least 2, and a rectal bleeding subscore of at least 1.
- Part C requires ulcerative colitis extending at least 15 centimeters from the anal verge, as determined by screening colonoscopy.
- Part C requires an inadequate response, loss of response, or intolerance to at least one conventional or advanced ulcerative colitis therapy.
- Participants must be able and willing to provide written informed consent.
Possible reasons someone may not be able to join
- Parts A and B exclude anyone with a physical or psychological condition that prevents study completion; Part C excludes such a condition if it prevents study participation.
- Part C excludes diagnoses of Crohn disease and the other listed non-ulcerative-colitis forms or causes of colitis.
- Part C excludes a positive screening result for Clostridium difficile toxins.
- All parts exclude people testing positive for human immunodeficiency virus, hepatitis B, or hepatitis C.
- All parts exclude cardiac arrhythmia or a clinically significant abnormal electrocardiogram.
- Parts A and B exclude active prescription-medication use within 14 days before Day -1 and active over-the-counter or herbal medication use within seven days of screening.
- Parts A and B exclude use of another investigational product within 30 days and blood or plasma donation within 60 days.
- Pregnant or breastfeeding people are excluded from all parts.
- The registry says additional protocol-defined inclusion and exclusion criteria also apply but does not list them.
Important unknowns
What the record does not make clear
- The registry does not state how many in-person visits are required or how often they occur.
- Part C periods are reported, but the record does not explicitly state total participation durations for Parts A and B.
- Parts A and B report a 3:1 XmAb942-to-placebo assignment ratio, but the Part C assignment ratio is not reported.
- The record does not state which ulcerative colitis treatments may be continued during Part C.
- Medication timing restrictions are listed for healthy participants, but Part C washout requirements are not reported.
- The registry does not explain what treatment is available if ulcerative colitis worsens during Part C.
- The record identifies a screening colonoscopy and 12-week endoscopic and histological outcomes but does not provide the full endoscopy schedule or preparation requirements.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report reimbursement or support for transportation, lodging, meals, or other travel expenses.
- The record does not say whether any visits or assessments can be completed remotely or locally.
- The registry does not describe access to XmAb942 after study treatment ends.
- The overall study and many locations are listed as recruiting, but the record does not identify which study part or cohort is open at each location.
Before contacting the site
Questions for the study team
- Which study part and cohort is currently enrolling at the location I would use?
- What is the complete visit schedule, including visit length, overnight stays, and which visits must occur at the study site?
- For Part C, what is the chance of receiving placebo, and what treatment is given during maintenance to people initially assigned placebo?
- Which current ulcerative colitis medicines can continue, which must stop, and what washout or stable-dose rules apply?
- How many colonoscopies or other endoscopic procedures are required, when are they performed, and will biopsies be taken?
- What happens if ulcerative colitis worsens during the study, and which rescue treatments are allowed?
- What risks, side effects, and monitoring requirements are known for XmAb942, including its subcutaneous and intravenous administration?
- Which costs are covered, and are compensation or travel support available?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what clinical risks would study participation create in my specific situation?
- How could stopping, washing out, or changing my current medicines affect disease control?
- What approved treatment alternatives remain reasonable for me given my prior response, loss of response, or intolerance?
- Would the required colonoscopy, endoscopic assessments, and possible tissue sampling pose particular concerns for me?
- How should you and the research team coordinate symptom monitoring, laboratory results, medications, and decisions if my disease worsens?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
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.
Study design and administration
- Organization
- Xencor, Inc.
- Organization class
- Industry
- Organization study ID
- XmAb942-01 (G942-101)
- Lead sponsor
- Xencor, Inc.
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Adult, Older Adult
Study arms
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.
Interventions: Biological: XmAb942
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.
Interventions: Drug: 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.
Interventions: Biological: XmAb942
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.
Interventions: Drug: Placebo
Active Comparator
Part C: Active
Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
Interventions: Biological: XmAb942
Placebo Comparator
Part C: placebo
Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis
Interventions: Drug: Placebo
Interventions
Biological
XmAb942
Antibody
Drug
Placebo
Placebo
Eligibility
18 Years–75 Years
All
Accepted
Inclusion criteria (15)
- Parts A and BRegistry-derived · unreviewed
- Age 18-55Registry-derived · unreviewed
- Must be in good health with no significant medical historyRegistry-derived · unreviewed
- Clinical laboratory values within normal rangeRegistry-derived · unreviewed
- BMI 18-35 (inclusive)Registry-derived · unreviewed
- Contraceptive use by men or women consistent with local regulationsRegistry-derived · unreviewed
- Able and willing to provide written informed consentRegistry-derived · unreviewed
- Part CRegistry-derived · unreviewed
- Age 18-75Registry-derived · unreviewed
- Must be in good health with no significant medical historyRegistry-derived · unreviewed
- UC diagnosis ≥ 3 months prior to screeningRegistry-derived · unreviewed
- Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1Registry-derived · unreviewed
- Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopyRegistry-derived · unreviewed
- Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies of UCRegistry-derived · unreviewed
- Able and willing to provide written informed consentRegistry-derived · unreviewed
Exclusion criteria (18)
- Parts A and BRegistry-derived · unreviewed
- Any physical or psychological condition that prohibits study completionRegistry-derived · unreviewed
- History of suicidal behavior or suicidal ideationRegistry-derived · unreviewed
- Heavy use of nicotine containing productsRegistry-derived · unreviewed
- HIV, hepatitis B and hepatitis C positiveRegistry-derived · unreviewed
- Cardiac arrhythmia, or clinically significant abnormal ECGRegistry-derived · unreviewed
- Active use of prescription medications within 14 days of Day -1Registry-derived · unreviewed
- Active use of over-the-counter, or herbal medication within 7 days of ScreeningRegistry-derived · unreviewed
- Other investigational products within 30 daysRegistry-derived · unreviewed
- Blood or plasma donation within 60 daysRegistry-derived · unreviewed
- Pregnant or breastfeedingRegistry-derived · unreviewed
- Part CRegistry-derived · unreviewed
- Any physical or psychological condition that prohibits study participationRegistry-derived · unreviewed
- Diagnosis of Crohn disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.Registry-derived · unreviewed
- Positive screen for Clostridium difficile (C. Difficile) toxinsRegistry-derived · unreviewed
- HIV, hepatitis B and hepatitis C positiveRegistry-derived · unreviewed
- Cardiac arrhythmia, or clinically significant abnormal ECGRegistry-derived · unreviewed
- Pregnant or breastfeedingRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A)
Time frame: 20 weeks
Primary outcome
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B)
Time frame: 28 weeks
Primary outcome
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.
Time frame: 12 weeks
A composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. It is calculated by adding the results from Mayo endoscopic subscore (MES) which measures GI bleeding, stool frequency subscore (SFS) which measures stool frequency per day, and rectal bleeding subscore (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.
Secondary outcome
Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)
Time frame: up to 20 weeks
• Cmax (Maximum concentration of drug)
Secondary outcome
Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)
Time frame: up to 20 weeks
• AUC0-last (Area under the curve drug concentration-time curve to last concentration)
Secondary outcome
Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)
Time frame: up to 28 weeks
• Cmax (Maximum concentration of drug)
Secondary outcome
Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)
Time frame: up to 28 weeks
• AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal rule
Secondary outcome
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) (Part C)
Time frame: 72 weeks
Secondary outcome
Discontinuations due to TEAEs (Part C)
Time frame: 72 weeks
Secondary outcome
Endoscopic improvement defined as (MES) of 0 or 1 (Part C).
Time frame: 12 weeks
Secondary outcome
Change from baseline in MS (Part C).
Time frame: 12 weeks
Secondary outcome
Clinical response based on MMS score (Part C) defined as decrease from baseline in the MMS of ≥ 2 points and at least a 30% reduction from baseline, and decrease of ≥ 1 point in RBS from baseline or absolute RBS ≤ 1
Time frame: 12 weeks
Secondary outcome
Histological improvement as determined by change in Robarts Histopathology Index (RHI) scores, ranging from 0 (no disease activity) to 33 (severe disease activity).
Time frame: 12 weeks
Recruiting locations in the United States
Xencor Investigative Site
RecruitingScottsdale, Arizona, 85255, United States
Xencor Investigative Site
RecruitingBradenton, Florida, 34209, United States
Xencor Investigative Site
RecruitingBrandon, Florida, 33511, United States
Xencor Investigative Site
RecruitingJacksonville, Florida, 32258, United States
Xencor Investigative Site
RecruitingKissimmee, Florida, 34741, United States
Xencor Investigative Site
RecruitingMargate, Florida, 33063, United States
Xencor Investigative Site
RecruitingPalmetto Bay, Florida, 33176, United States
Xencor Investigative Site
RecruitingTampa, Florida, 33612, United States
Xencor Investigative Site
RecruitingTampa, Florida, 33613, United States
Xencor Investigative Site
RecruitingLouisville, Kentucky, 40218, United States
Xencor Investigative Site
RecruitingOxford, Mississippi, 38655, United States
Xencor Investigative Site
RecruitingTupelo, Mississippi, 38801, United States
Xencor Investigative Site
RecruitingAlbany, New York, 12206, United States
Xencor Investigative Site
RecruitingRochester, New York, 14618, United States
Xencor Investigative Site
RecruitingRaleigh, North Carolina, 27612, United States
Xencor Investigative Site
RecruitingBeavercreek, Ohio, 45440, United States
Xencor Investigative Site
RecruitingCordova, Tennessee, 38018, United States
Xencor Investigative Site
RecruitingCedar Park, Texas, 78613, United States
Xencor Investigative Site
RecruitingDenton, Texas, 76201, United States
Xencor Investigative Site
RecruitingGarland, Texas, 75044, United States
Xencor Investigative Site
RecruitingGeorgetown, Texas, 78628, United States
Xencor Investigative Site
RecruitingHouston, Texas, 77024, United States
Xencor Investigative Site
RecruitingHouston, Texas, 77090, United States
Xencor Investigative Site
RecruitingKingwood, Texas, 77339, United States
Xencor Investigative Site
RecruitingLubbock, Texas, 79424, United States
Xencor Investigative Site
RecruitingSan Antonio, Texas, 78229, United States
Xencor Investigative Site
RecruitingTyler, Texas, 75701, United States
Xencor Investigative Site
RecruitingWebster, Texas, 77598, United States
Xencor Investigative Site
RecruitingRichmond, Virginia, 23229, United States
This study also lists 61 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Oct 1, 2024
- Primary completion
- Apr 2028
- Overall completion
- Jan 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.