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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06331728




Registration number
NCT06331728
Ethics application status
Date submitted
12/03/2024
Date registered
26/03/2024
Date last updated
4/11/2024

Titles & IDs
Public title
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study with Single Blind Sentinel Period to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IGNX001 in Peanut-Allergic Participants
Secondary ID [1] 0 0
IGNX-T1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IGNX001
Treatment: Drugs - Placebo

Experimental: IGNX001 - Participants will receive IGNX001 given as a single subcutaneous dose on Day 1.

Placebo comparator: Placebo - Participants will receive IGNX001 placebo given as a single subcutaneous dose on Day 1.


Treatment: Drugs: IGNX001
IGNX001 given as a single subcutaneous dose on Day 1.

Treatment: Drugs: Placebo
Placebo to IGNX001 given as a single subcutaneous dose on Day 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Severity of Treatment Emergent Adverse Events
Timepoint [1] 0 0
From time of dose until Exit Visit/Early Termination Visit or until AE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
Primary outcome [2] 0 0
Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
Timepoint [2] 0 0
From consent until Exit Visit/Early Termination Visit or until SAE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
Primary outcome [3] 0 0
Number of Participants with Clinically significant Changes from Baseline - Hematology
Timepoint [3] 0 0
Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Primary outcome [4] 0 0
Number of Participants with Clinically Significant Changes from Baseline - Chemistry
Timepoint [4] 0 0
Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Primary outcome [5] 0 0
Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves
Timepoint [5] 0 0
Assessed at Screening, Days 1, 15, and 85 (up to 25 weeks).
Primary outcome [6] 0 0
Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations
Timepoint [6] 0 0
Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Secondary outcome [1] 0 0
Concentration of IGNX001 in the Plasma
Timepoint [1] 0 0
Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Secondary outcome [2] 0 0
Measurement of Area under the Plasma/Serum Concentration Curve (AUC)
Timepoint [2] 0 0
Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Secondary outcome [3] 0 0
Peak Serum Concentration (Cmax)
Timepoint [3] 0 0
Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Secondary outcome [4] 0 0
Time to Peak Serum Concentration (Tmax)
Timepoint [4] 0 0
Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, Day 71 and 85 (up to 13 weeks).
Secondary outcome [5] 0 0
Elimination Half-life (t1/2)
Timepoint [5] 0 0
Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Secondary outcome [6] 0 0
Changes Over Time to Anti-drug Antibodies
Timepoint [6] 0 0
Assessed at Day 1, Day 15, Day 29, Day 57 and 85 (up to 13 weeks).

Eligibility
Key inclusion criteria
Key

* History of physician-diagnosed peanut allergy with clinical reaction to peanut within 2 hours of exposure to peanut or peanut-containing food (within the last 15 years).
* Peanut specific IgE level = 5 kUA/L.
* Positive peanut SPT with wheal diameter = 5 mm.

Key
Minimum age
15 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of severe or life-threatening anaphylaxis requiring intubation or admission to intensive care unit within 1 year prior to Screening.
* Current, or within the past year, treatment with food allergen immunotherapy or participation in a food allergy immunotherapy study.
* Current treatment with aeroallergen immunotherapy, except if on stable monthly maintenance SC aeroallergen immunotherapy.

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
1/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,Washingto
Recruitment hospital [1] 0 0
St Vincent's Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Monash Health, Sleep, Allergy, and Immunology - Clayton
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
6150 - Murdoch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
IgGenix Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents.
Trial website
https://clinicaltrials.gov/study/NCT06331728
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jessica Grossman, MD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06331728