Decoding Autism Now · IMIG Initiative
The Trial
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Decoding Autism Now · IMIG Initiative

The TrialDesign rationale, infrastructure, and what funding enables

This trial is not a proposal searching for everything. The investigator, the clinical research organisation, the patient population, the manufacturing pathway, and the endpoint framework are already defined. What is needed is the funding to initiate.

Trial design in formation with TASK Clinical
Section 01 — Infrastructure Status

01What already exists

The most significant barrier to most early-phase clinical trials is not funding — it is the absence of the scientific, clinical, and operational infrastructure needed to use funding effectively. For this trial, that infrastructure is substantially in place.

Principal Investigator
Dr. Pieter Rousseau Fourie
Consultant Paediatrician with PhD in Medical Physiology. Author of the first published IMIG case report in ASD/PANS (2024). Currently treating 40+ patients with IMIG. The scientific and clinical case for the trial is his clinical programme at scale.
In place
Clinical Research Organisation
TASK Clinical, South Africa
TASK (TB Alliance for South African Knowledge) is an established CRO with a track record in paediatric and infectious disease trials. TASK Clinical leads trial design. Initial trial design discussions are underway as of April 2026.
In place
Investigational Product
Established 16% IgG IMIG Formulations
Multiple established IMIG products are suitable for the trial. Available 16% IgG formulations have well-documented manufacturing processes, safety profiles, and regulatory history. Cost per dose ranges from approximately $50–$80 depending on supplier and region. No novel drug development is required — this trial uses existing, approved products.
Identified
Patient Population
Biomarker-defined ASD subgroup
Children aged 3–12 with ASD (DSM-5) and documented neuroimmune markers. The candidate identification framework provides a validated clinical pathway for identifying eligible patients. Dr. Fourie's existing patient population provides a naturalistic dataset for refining inclusion criteria.
Defined
Formal Budget
In development with TASK Clinical
TASK is developing the formal trial budget. Figures will be published on this page when finalised. The cost structure is expected to be substantially lower than equivalent trials in high-income settings due to the South African clinical environment and the use of established, low-cost investigational products.
In development
Regulatory Pathway
South African Health Products Regulatory Authority (SAHPRA)
Initial trial to be conducted under SAHPRA oversight. South Africa offers a well-established regulatory framework for investigational clinical trials, with a track record of supporting early-phase studies in paediatric populations. Regulatory strategy to be finalised with TASK.
In development
Section 02 — Trial Design

02Design rationale — the scientific case for each choice

Every element of the trial design is derived from the mechanistic and clinical evidence reviewed on the preceding pages. The patient selection criteria, the treatment duration, and the endpoint selection are not arbitrary — they follow directly from what the IVIG literature, the IMIG case report, and the cascade model collectively predict.

Proposed IMIG for Autism Controlled Pilot Study — Design Framework
Phase
Controlled pilot — safety, preliminary efficacy, and biomarker validation in a defined subpopulation
Study design
Randomised, double-blind, placebo-controlled. Parallel arms: IMIG (0.2 mL/kg monthly) vs. matched volume saline intramuscular injection
Population
Children aged 3–12, ASD (DSM-5) with documented neuroimmune markers at screening: elevated IFN-γ, TNF-α, or IL-6; IgG subclass deficiency; elevated kynurenine/tryptophan ratio; or anti-brain autoantibodies. Regression phenotype prioritised in stratification.
Treatment duration
6 months minimum. Derived from the cascade recovery timeline: SIRT1 recovery, SST normalisation, and CREB/BDNF-dependent plasticity restoration each require weeks of sustained inflammatory suppression. Six months provides the minimum window to observe meaningful cascade-level change.
Dose & schedule
IMIG 0.2 mL/kg (16% IgG formulation) intramuscularly, once monthly. Derived from the Fourie & Armstrong 2024 case report protocol, which established preliminary safety and dosing parameters.
Follow-up
3-month post-treatment follow-up to assess durability of response and document any loss-of-effect pattern — directly testing whether IMIG's sustained profile produces more durable gains than the IVIG discontinuation data predicts
Section 03 — Endpoints

03What the trial measures

The endpoint framework is designed to do three things simultaneously: replicate the established IVIG literature's measurement approach (enabling cross-study comparison), capture biomarker-level cascade evidence (establishing mechanism rather than just effect), and measure functional outcomes meaningful to families and clinicians.

Endpoint Type Rationale
ABC-Irritability Subscale (Aberrant Behaviour Checklist) Primary Established precedent from IVIG literature — enables direct comparison with Rossignol & Frye 2021 meta-analysis effect sizes. FDA-recognised for ASD trials.
Pro-inflammatory cytokines — IFN-γ, TNF-α, IL-6 Secondary Direct measure of IDO1 upstream drivers. Reduction confirms mechanism of action. Correlates with clinical response in prior IVIG studies.
Kynurenine/tryptophan ratio Secondary Direct measure of IDO1 activity and kynurenine pathway flux. A reduction confirms upstream cascade suppression, not merely symptomatic improvement.
Social Responsiveness Scale (SRS-2) Secondary Standardised measure of social communication and interaction. Sensitive to change in intervention trials and clinically meaningful to families.
Vineland Adaptive Behaviour Scales Secondary Functional independence measure — captures real-world skill acquisition and regression, particularly relevant for the regression phenotype subgroup.
Safety & tolerability — adverse events, injection site reactions, full blood count, immunoglobulin levels Safety Required for regulatory filing. The Fourie & Armstrong case report established a strong preliminary safety signal; this trial provides systematic documentation.
Section 04 — Current Momentum

04Where the initiative stands — April 2026

This trial is in active formation. The scientific case has been developed, the key clinical collaborators are engaged, and the trial design framework is under development. The following developments have occurred in the weeks preceding this page's publication.

Recent developments — April 2026

The formal budget figure will be published on this page when it is finalised by TASK Clinical. Interested funders who would like to discuss the trial before that figure is available are welcome to make contact directly — see the Contact page.

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Research context — not clinical guidance. The trial design described on this page is a proposed framework under active development. It has not yet been submitted to or approved by any regulatory authority. IMIG for ASD is investigational and not approved for this indication in any jurisdiction.