Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE) (ARC011)
Study ID: STU 032018-029
This is a phase 3, multicenter, north american, open-label, pivotal safety extension study for those subjects who received aR101 therapy in aRC007 and completed the study. The exit Visit procedures of aRC007 will serve as part of the Screening/Baseline Visit (Visit 1) for this study (aRC011), unless specified otherwise. eligibility will be determined after subjects provide written informed consent (and assent if required per local regulations) for the aRC011 study. upon successful completion of the Screening/Baseline visit, subjects will be asked to return to the clinic every 4 weeks for a total of 6 additional visits (Visits 2-7) over an approximately 6 month timeframe. Subjects will continue to dose with aR101 300 mg QD for the duration of the 6 month maintenance period, unless they need to have their dose adjusted per protocol stipulations. at the end of the maintenance period, subjects will undergo an exit Visit (Visit 7) for this study. Procedures to be performed at each visit are listed in the Schedule of events Table. eligible subjects who would like to continue treatment with aR101 following completion of the current study will be offered the opportunity to participate in the open-label safety study aRC008. adverse events of interest (aei) will be monitored and reported similarly to how they were monitored and reported in aRC007 (RaMSeS). Study endpoints: Frequency of treatment-emergent adverse events (aes), including serious aes, during the overall study period * Frequency of premature discontinuation of dosing due to aes * Frequency of premature discontinuation of dosing due to chronic/recurrent gastrointestinal (Gi) aes * Proportion of chronic/recurrent Gi aes resolving at 2, 4, and [GreaterThanorequalTo] 12 weeks following cessation of dosing * Frequency of allergic hypersensitivity reactions aes * Frequency of anaphylaxis as defined in the protocol * Frequency of use of epinephrine as a rescue medication * Frequency of reported accidental/nonaccidental ingestion of peanut and other allergenic foods and severity of any resultant reactions * assessment of asthma control using the Childhood asthma Control Test (C-aCT) and asthma Control Test (aCT) * Frequency of aes that lead to early withdrawal
Subjects must meet all the following criteria to be eligible: 1. Prior to commencing any study related activities, the subject or parent/guardian must provide written informed consent. For minors, assent will be obtained as required by the institutional review board (IRB)/ethics committee (EC). 2. Received AR101 in study ARC007. 3. Completed the ARC007 study. 4. Use of effective birth control by sexually active female subjects of childbearing potential.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- JOHN ANDREW BIRD
The objective of this study is to describe the 6 month safety and tolerability of maintenance dosing with aR101 300 mg once daily (QD) orally in peanut-allergic children who received aR101 and completed the aRC007 study.