Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency As Open Label Extension (NCT03512314) | Clinical Trial Compass
CompletedPhase 3
Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency As Open Label Extension
United States11 participantsStarted 2018-01-24
Plain-language summary
This is an open-label extension study for patients previously enrolled in the AB2 Bio Ltd. ongoing Phase III clinical trial NLRC4/XIAP.2016.001 (IND N° 127953). This OLE study will evaluate the long-term safety and tolerability of Tadekinig alfa in patients suffering from pediatric monogenic autoinflammatory diseases harboring deleterious mutations of NLRC4 and XIAP.
Who can participate
SexALL
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Inclusion criteria
✓. Patients have participated in AB2 Bio ltd. Phase III clinical trial NLRC4/XIAP.2016.001 (IND N° 127953) by one of the following mechanisms : a) Patients that have completed the first 18-week RCT phase of the preceding clinical trial but were not eligible for the RW phase due to flare symptoms. Or b) Patients that completed the first 18-week RCT phase and completed the RW phase of the preceding clinical trial. Or c) Patients who have exited either the RCT or RW phase of the preceding clinical trial due to treatment failure requiring rescue immunosuppression. Such patients must wait a minimum of 4 weeks after treatment discontinuation from the preceding clinical trial before enrolling in this OLE. If patients do not consent to enroll in the OLE after their early termination in the main study, they will be asked to continue with the planned visits of the main study
✓. Women of childbearing potential with negative urine pregnancy test (UPT) at all visits
Exclusion criteria
✕. Patients may not enter the OLE if they voluntarily withdrew from RCT or RW study or if the time period between participation exceeds 3 months
✕. Evidence or history of malignancy
✕. Evidence of invasive or life-threatening infection
✕. History of tuberculosis
✕. Life-threatening bleeding within 2 weeks of screening
✕. Vaccination with a live vaccine within the previous 3 months
✕. Evidence of severe organ compromise including but not limited to: (see details in the protocol)
What they're measuring
1
Reports of adverse events
Timeframe: 26 weeks
2
Reports of abnormal physical examination
Timeframe: 26 weeks
3
Reports of abnormal laboratory results
Timeframe: 26 weeks
4
Immunogenicity evaluation
Timeframe: 26 weeks
5
Evaluation of the local tolerability at the injection site