TerminatedPhase 3

Open-Label Extension of EryDex Study IEDAT-04-2022

Stopped: eDSP development discontinued

United States101 participantsStarted 2024-12-11

Plain-language summary

This is an international, multi-center, prospective, open-label, non-comparative study aiming to provide access to treatment with EryDex to ataxia telangiectasia (A-T) patients who completed the IEDAT-04-2022 trial which studied the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).

Who can participate

Age range6 Years

SexALL

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Inclusion Criteria: * body weight ≥15 kg * participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments Exclusion Criteria: * safety contraindications for continuation of treatment, as determined by the investigator * clinically significant immune impairment that, in the opinion of the Investigator, precludes further treatment with corticosteroids * Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years. * requiring treatment with a systemic corticosteroid

What they're measuring

Number of Participants With Treatment Emergent Adverse Events

Timeframe: through study completion, up to approximately 13 months

Number of Participants With Treatment Emergent Adverse Events Leading to Intervention Discontinuation

Timeframe: through study completion, up to approximately 13 months

Number of Participants With Serious Adverse Events

Timeframe: through study completion, up to approximately 13 months

Trial details

NCT IDNCT06664853

SponsorQuince Therapeutics S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-30

Results submitted2026-03-25

View on ClinicalTrials.gov More Ataxia Telangiectasia trials