AbataCept for the Treatment of Immune-cHeckpoint Inhibitors Induced mYocarditiS

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

October 4, 2022

Primary Completion Date

March 5, 2024

Study Completion Date

September 15, 2025

Conditions
Myocarditis
Interventions
DRUG

Abatacept 250 MG

Abatacept will be administered by intravenous injection over 1h15 to 2h30 on D1, D5+/-2 and D14+/-2 at 10mg/kg (arm A), or 20mg/kg (arm B) or 25mg/kg (arm C) depending on the randomization (max 3 000 mg per administration). Starting Day 21 (after evaluation of the primary outcome), other injection of abatacept may be given (D22 at D90) with dosage (10 or 20mg/kg max) decided by the treating physician (max 2 500 mg per administration) as a function of the relapse or not of the ICI myocarditis after immunosuppressant therapeutics tapering. After day 21, the administrations will be carried out in open but the blind administration 1 to 3 (D1 to D21) will be kept.

Trial Locations (1)

75013

Hôpital Pitié Salpêtrière, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER