Trial Outcomes & Findings for Open-Label Extension of EryDex Study IEDAT-04-2022 (NCT NCT06664853)

NCT ID: NCT06664853

Last Updated: 2026-05-05

Results Overview

Number of participants presenting at least one treatment emergent adverse event (TEAE)

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

101 participants

Primary outcome timeframe

through study completion, up to approximately 13 months

Results posted on

2026-05-05

Participant Flow

102 participants completed the full treatment period in the IEDAT-04-2022 study (NEAT), 101 NEAT study participants subsequently consented and enrolled in the open-label extension study IEDAT-05-2024 study (NEAT-OLE).

Participant milestones

Participant milestones
Measure	Dexamethasone Sodium Phosphate IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using EDS (formerly known as "EryDex System")
Overall Study STARTED	101
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	101

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexamethasone Sodium Phosphate IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using EDS (formerly known as "EryDex System")
Overall Study Study terminated by Sponsor. No completers	101

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone Sodium Phosphate n=101 Participants IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using EDS (formerly known as "EryDex System")
Age, Categorical <=18 years	101 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=54 Participants
Age, Categorical >=65 years	0 Participants n=54 Participants
Sex: Female, Male Female	48 Participants n=54 Participants
Sex: Female, Male Male	53 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants
Race (NIH/OMB) Asian	6 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	5 Participants n=54 Participants
Race (NIH/OMB) White	86 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=54 Participants

PRIMARY outcome

Timeframe: through study completion, up to approximately 13 months

Population: The analysis population contains all participants who received at least one study drug infusion in this open label extension study

Number of participants presenting at least one treatment emergent adverse event (TEAE)

Outcome measures

Outcome measures
Measure	Dexamethasone Sodium Phosphate n=101 Participants IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using EDS (formerly known as "EryDex System")
Number of Participants With Treatment Emergent Adverse Events	71 Participants

PRIMARY outcome

Timeframe: through study completion, up to approximately 13 months

Number of participants presenting at least one treatment emergent adverse event (TEAE) leading to intervention discontinuation

Outcome measures

Outcome measures
Measure	Dexamethasone Sodium Phosphate n=101 Participants IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using EDS (formerly known as "EryDex System")
Number of Participants With Treatment Emergent Adverse Events Leading to Intervention Discontinuation	1 Participants

PRIMARY outcome

Timeframe: through study completion, up to approximately 13 months

Number of participants presenting at least one serious adverse event (SAE)

Outcome measures

Outcome measures
Measure	Dexamethasone Sodium Phosphate n=101 Participants IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using EDS (formerly known as "EryDex System")
Number of Participants With Serious Adverse Events	5 Participants

Adverse Events

Dexamethasone Sodium Phosphate

Serious events: 5 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dexamethasone Sodium Phosphate n=101 participants at risk IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using EDS (formerly known as "EryDex System")
Gastrointestinal disorders Constipation	0.99% 1/101 • From first dose through study completion approximately 13 months
Cardiac disorders Tachycardia	0.99% 1/101 • From first dose through study completion approximately 13 months
Injury, poisoning and procedural complications Gastrostomy tube site complication	0.99% 1/101 • From first dose through study completion approximately 13 months
Infections and infestations Influenza A	0.99% 1/101 • From first dose through study completion approximately 13 months
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.99% 1/101 • From first dose through study completion approximately 13 months
General disorders Lymphadenopathy in nasopharynx	0.99% 1/101 • From first dose through study completion approximately 13 months

Other adverse events

Other adverse events
Measure	Dexamethasone Sodium Phosphate n=101 participants at risk IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using EDS (formerly known as "EryDex System")
Skin and subcutaneous tissue disorders Pruritus	17.8% 18/101 • From first dose through study completion approximately 13 months
Skin and subcutaneous tissue disorders Erythema	5.0% 5/101 • From first dose through study completion approximately 13 months
Gastrointestinal disorders Vomiting	11.9% 12/101 • From first dose through study completion approximately 13 months
Gastrointestinal disorders Diarrhoea	5.9% 6/101 • From first dose through study completion approximately 13 months
Gastrointestinal disorders Gastroenteritis	5.9% 6/101 • From first dose through study completion approximately 13 months
Infections and infestations Nasopharyngitis	10.9% 11/101 • From first dose through study completion approximately 13 months
Infections and infestations Upper respiratory tract infection	8.9% 9/101 • From first dose through study completion approximately 13 months
Infections and infestations Viral infection	6.9% 7/101 • From first dose through study completion approximately 13 months
Infections and infestations Influenza	5.9% 6/101 • From first dose through study completion approximately 13 months
General disorders Pyrexia	6.9% 7/101 • From first dose through study completion approximately 13 months
General disorders Fatigue	5.0% 5/101 • From first dose through study completion approximately 13 months
Respiratory, thoracic and mediastinal disorders Cough	5.9% 6/101 • From first dose through study completion approximately 13 months
Respiratory, thoracic and mediastinal disorders Rhinitis	5.0% 5/101 • From first dose through study completion approximately 13 months

Additional Information

Chief Medical Officer

Quince Therapeutics

Phone: +1 415 910 5717

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60