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Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
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.
Study details:
This study is a Phase 1 randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers, followed by a cohort of three repeating doses in healthy volunteers. The third part of this study will be a Phase 2, randomized, placebo controlled, double blind evaluation of participants with Ulcerative Colitis with a dose determined from Parts A and B. This study consists of 3 parts, as follows:.
Part A: SAD in healthy participants, will entail administration of XmAb942 or matching placebo. Part B: Repeat Dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo. Part C: Participants with UC to receive XmAb942 or placebo with dose determined from Part A and Part B.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-10-10
Primary completion: 2026-10-01
Study completion finish: 2027-10-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06619990
Intervention or treatment
BIOLOGICAL: XmAb942
DRUG: Placebo
Conditions
- • Ulcerative Colitis (UC)
Find a site
Closest Location:
Linear Clinical Research
Research sites nearby
Select from list below to view details:
Linear Clinical Research
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Part A: Active drug
| BIOLOGICAL: XmAb942
|
PLACEBO_COMPARATOR: Part A: Placebo
| DRUG: Placebo
|
ACTIVE_COMPARATOR: Part B: Active
| BIOLOGICAL: XmAb942
|
PLACEBO_COMPARATOR: Part B: Placebo
| DRUG: Placebo
|
ACTIVE_COMPARATOR: Part C: Active
| BIOLOGICAL: XmAb942
|
PLACEBO_COMPARATOR: Part C: placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A cohort) | Not Specified | 20 weeks |
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) with repeated doses of XmAb942 in healthy volunteers (Part B cohort) | Not Specified | 28 weeks |
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) with repeated doses of XmAb942 in participants with UC (Part C) | Not Specified | 12 weeks |
Clinical outcomes of multiple doses of XmAb942 in participants with UC, as determined by the Modified Mayo Score, Rectal Bleeding score, Stool Frequency Score, and Endoscopic subscore (Part C) | The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. This is calculated by adding the results from Endoscopic Subscore (ES) which measures GI bleeding, Stool Frequency Subscore (SFS) which measures stool frequency per day, and Rectal Bleeding Score (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3. | 12 weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Proportion of participants with histologic-endoscopic remission (Part C). | Histologic-endoscopic remission (HER) is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | 12 weeks |
Proportion of participants with endoscopic remission (Part C). | Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | 12 weeks |
Proportion of participants with endoscopic improvement (Part C) | Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | 12 weeks |
Proportion of participants with histologic-endoscopic improvement (Part C). | Histologic-endoscopic improvement is defined as a Geboes score ≤3.1, together with a Mayo Score for ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | 12 weeks |
Change from baseline in partial Modified Mayo score (Part C). | The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (typical number of stools per day for the participant) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (only passing blood). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1. | 12 weeks |
Proportion of participants with clinical response per Modified Mayo Score (MMS) (Part C). | The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. This is calculated by adding the results from Endoscopic Subscore (ES) which measures bleeding GI bleeding, Stool Frequency Subscore (SFS) which measures stool frequency per day, and Rectal Bleeding Score, which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3. | 12 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort) | Cmax (Maximum concentration of drug in plasma) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort) | Tmax (Time to maximum concentration of drug in plasma) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort) | AUC0-last(Area under the plasma drug concentration-time curve to last concentration) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort) | AUC0-inf(Area under the plasma drug concentration-time curve from 0 to infinity) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort) | CL/F (Apparent) total body clearance, calculated as: Dose / AUCinf or Dose / AUCtau (steady state) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort) | t1/2(Terminal elimination half-life) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort) | AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal rule | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort) | Cmax (Maximum concentration of drug in plasma) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort) | Tmax (Maximum concentration of drug in plasma) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort) | AUC0-last (Area under the plasma drug concentration-time curve to last concentration) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort) | AUC0-inf (Area under the plasma drug concentration-time curve from 0 to infinity) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort) | T1/2 (Terminal elimination half-life) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort) | CL/F (Apparent) total body clearance, calculated as: Dose / AUCinf or Dose / AUCtau (steady state) | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort) | AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal rule | up to 28 weeks |
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C) | Cmax (Maximum concentration of drug in plasma) | up to 12 weeks |
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C) | Tmax (Time to maximum concentration of drug in plasma) | up to 12 weeks |
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C) | AUC0-last (Area under the plasma drug concentration-time curve to last concentration) | up to 12 weeks |
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C) | AUC0-inf (Area under the plasma drug concentration-time curve from 0 to infinity) | up to 12 weeks |
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C) | T1/2 (Terminal elimination half-life) | up to 12 weeks |
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C) | CL/F (Apparent) total body clearance, calculated as: Dose / AUCinf or Dose / AUCtau (steady state) | up to 12 weeks |
Frequently Asked Questions
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