Studio di estensione di fase 3 per valutare la sicurezza a lungo termine di ADX-324 in pazienti con angioedema ereditario

Baseline Assessment

After joining the study, you attend a baseline visit where personal Health information, history of Hereditary angioedema, and current medication use are recorded.

Laboratory tests are taken to establish a safety reference point before any study medication is given.

First study medication administration

During the same visit, you receive the first dose of the study medication by subcutaneous injection.

The injection contains either ADX-324 (the test drug) or sterile normal saline (the placebo).

The labelled dose is 00 mg for each injection.

Repeat dosing Schedule

You continue to receive additional injections of the assigned study medication at regular intervals defined by the protocol.

Each injection is administered by subcutaneous injection with the same 00 mg dose.

The repeat dosing continues for the duration of the extension study, which may last until APRIL 2030.

Ongoing safety monitoring

At each follow‑up visit you report any side effects, known as treatment‑emergent adverse events, and any occurrences of Hereditary angioedema attacks.

Clinical assessments and laboratory tests are performed to evaluate long‑term safety of the repeated doses.

Final Evaluation

After the last scheduled injection, a final visit is conducted.

The final Assessment includes a complete safety review, documentation of any remaining adverse events, and a summary of the number of Hereditary angioedema attacks during the study period.