Clinical trial NCT06619990: Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis (UC)
Keywords: Ulcerative Colitis
Inflammatory Bowel Disease
Healthy Volunteers
Lead sponsor: GALE Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Xencor, Inc.
First posted: 2024-10-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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: 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 18-55
* Must be in good health with no significant medical history
* UC diagnosis
* 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

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 completion
* Diagnosis of Crohn disease, pouchitis, or indeterminate colitis
* Positive screen for Clostridium difficile (C. Difficile)
* 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
* Other investigational products within 30 days
* Blood or plasma donation within 60 days
* Pregnant or breastfeeding

Primary outcomes:
measure: Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A cohort)
timeFrame: 20 weeks
measure: 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)
timeFrame: 28 weeks
measure: 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)
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of participants with histologic-endoscopic remission (Part C).
timeFrame: 12 weeks
measure: Proportion of participants with endoscopic remission (Part C).
timeFrame: 12 weeks
measure: Proportion of participants with endoscopic improvement (Part C)
timeFrame: 12 weeks
measure: Proportion of participants with histologic-endoscopic improvement (Part C).
timeFrame: 12 weeks
measure: Change from baseline in partial Modified Mayo score (Part C).
timeFrame: 12 weeks
measure: Proportion of participants with clinical response per Modified Mayo Score (MMS) (Part C).
timeFrame: 12 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
timeFrame: up to 28 weeks
measure: Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
timeFrame: up to 12 weeks
measure: Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
timeFrame: up to 12 weeks
measure: Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
timeFrame: up to 12 weeks
measure: Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
timeFrame: up to 12 weeks
measure: Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
timeFrame: up to 12 weeks
measure: Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
timeFrame: up to 12 weeks
Other outcomes:
measure: The effect of XmAb942 on protein(s) and biomarkers
timeFrame: 28 weeks
Locations:
city: Joondalup
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: Linear Clinical Research
name: Jasmine Williams
role: PRINCIPAL_INVESTIGATOR
References: