Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
19/09/2024

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
Royal Melbourne Hospital - Parkville
Recruitment hospital [3] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 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
Trial website
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
jgrossman@iggenix.com
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT06331728