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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06619990




Registration number
NCT06619990
Ethics application status
Date submitted
20/09/2024
Date registered
1/10/2024

Titles & IDs
Public title
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Scientific 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.
Secondary ID [1] 0 0
G942-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - XmAb942
Treatment: Drugs - Placebo

Active comparator: Part A: Active drug - Active XmAb942 to be administered to healthy volunteers (SAD). Participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered once via either subcutaneous injection or intravenous infusion. Each dose cohort will have 8 participants receiving the dose as a subcutaneous injection, and 8 participants receiving the dose as an IV infusion. Randomization to each SAD cohort will be done in a staggered manner; initially 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed. After a safety evaluation period of the dose without clinically significant adverse events (AEs) then 6 additional participants will be randomized and dosed (5 active and 1 placebo) at the discretion of the Investigator according to the randomization schedule. A Safety Review Committee (SRC) will review data prior to escalation to the next dose level.

Placebo comparator: Part A: Placebo - Placebo Comparator to be administered to healthy volunteers (SAD). Participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered once via either subcutaneous injection or intravenous infusion. Each dose cohort will have 8 participants receiving the dose as a subcutaneous injection, and 8 participants receiving the dose as an IV infusion. Randomization to each SAD cohort will be done in a staggered manner; initially 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed. After a safety evaluation period of the dose without clinically significant adverse events (AEs) then 6 additional participants will be randomized and dosed (5 active and 1 placebo) at the discretion of the Investigator according to the randomization schedule. A Safety Review Committee (SRC) will review data prior to escalation to the next dose level.

Active comparator: Part B: Active - Active XmAb942 to be administered to healthy volunteers. Participants will be randomized in a 3:1 ratio to active or placebo. Determination of route of administration will be performed by SRC prior to initiation of Part B. Each dose cohort will have 8 participants receiving the dose as a subcutaneous infusion, and 8 participants receiving the dose as an IV infusion. The SRC may review data for determination of the next dose cohort.

Placebo comparator: Part B: Placebo - Placebo Comparator to be administered to healthy volunteers. Participants will be randomized in a 3:1 ratio to active or placebo. Determination of route of administration will be performed by SRC prior to initiation of Part B.

Each dose cohort will have 8 participants receiving the dose as a subcutaneous infusion, and 8 participants receiving the dose as an IV infusion. The SRC may review data for determination of the next dose cohort.

Active comparator: Part C: Active - Active XmAb942 to be administered to participants with Ulcerative Colitis. The SRC will provide recommendations on the doses in Part C based on emerging Part A and/or Part B data.

Placebo comparator: Part C: placebo - Placebo Comparator to be administered to participants with Ulcerative Colitis. The SRC will provide recommendations on the doses, frequency and route of administration to be assessed in Part C based on emerging Part A and/or Part B data


Treatment: Other: XmAb942
Antibody

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A cohort)
Timepoint [1] 0 0
20 weeks
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
28 weeks
Primary outcome [3] 0 0
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)
Timepoint [3] 0 0
12 weeks
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
12 weeks
Secondary outcome [1] 0 0
Proportion of participants with histologic-endoscopic remission (Part C).
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Proportion of participants with endoscopic remission (Part C).
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Proportion of participants with endoscopic improvement (Part C)
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Proportion of participants with histologic-endoscopic improvement (Part C).
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Change from baseline in partial Modified Mayo score (Part C).
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Proportion of participants with clinical response per Modified Mayo Score (MMS) (Part C).
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
Timepoint [7] 0 0
up to 28 weeks
Secondary outcome [8] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
Timepoint [8] 0 0
up to 28 weeks
Secondary outcome [9] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
Timepoint [9] 0 0
up to 28 weeks
Secondary outcome [10] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
Timepoint [10] 0 0
up to 28 weeks
Secondary outcome [11] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
Timepoint [11] 0 0
up to 28 weeks
Secondary outcome [12] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
Timepoint [12] 0 0
up to 28 weeks
Secondary outcome [13] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)
Timepoint [13] 0 0
up to 28 weeks
Secondary outcome [14] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
Timepoint [14] 0 0
up to 28 weeks
Secondary outcome [15] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
Timepoint [15] 0 0
up to 28 weeks
Secondary outcome [16] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
Timepoint [16] 0 0
up to 28 weeks
Secondary outcome [17] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
Timepoint [17] 0 0
up to 28 weeks
Secondary outcome [18] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
Timepoint [18] 0 0
up to 28 weeks
Secondary outcome [19] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
Timepoint [19] 0 0
up to 28 weeks
Secondary outcome [20] 0 0
Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)
Timepoint [20] 0 0
up to 28 weeks
Secondary outcome [21] 0 0
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
Timepoint [21] 0 0
up to 12 weeks
Secondary outcome [22] 0 0
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
Timepoint [22] 0 0
up to 12 weeks
Secondary outcome [23] 0 0
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
Timepoint [23] 0 0
up to 12 weeks
Secondary outcome [24] 0 0
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
Timepoint [24] 0 0
up to 12 weeks
Secondary outcome [25] 0 0
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
Timepoint [25] 0 0
up to 12 weeks
Secondary outcome [26] 0 0
Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)
Timepoint [26] 0 0
up to 12 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Joondalup
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6027 - Joondalup
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GALE Therapeutics Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Xencor, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jasmine Williams
Address 0 0
Linear Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sharron Gargosky
Address 0 0
Country 0 0
Phone 0 0
+1 503 673-3842?
Fax 0 0
Email 0 0
sgargosky@galetherapeutics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06619990