In the LIBERTY-PN PRIME and PRIME2 phase 3 trials, Dupilumab, a monoclonal antibody that blocks IL-4 & IL-13 signaling, significantly reduced itch & skin lesions in patients w/ PrurigoNodularis, a chronic inflammatory skin disease. NMEDclinical
Patients were enrolled in PRIME or PRIME2 if all the following inclusion criteria applied:PN diagnosed by a dermatologist for at least 3 months before the screening visitBaseline pruritus NRS average score for maximum itch intensity was determined based on the average of daily NRS scores for maximum intensity during the 7 days immediately preceding randomization ; for patients who did not have at least four daily scores reported during the 7 days immediately preceding the planned randomization...
Female patients were eligible to participate if they were not pregnant or breastfeeding and at least one of the following conditions applied:Is a WOCBP and agreed to use a contraceptive method during the study Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol; in countries where legal age of majority is above 18 years, a specific ICF was signed by the patient’s legally authorized representative.
Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and laboratory assessments have ruled out active infection before randomization History of systemic hypersensitivity or anaphylaxis to any biologic therapy, including any excipients Initiation of treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, menthol, polidocanol or filaggrin degradation products during the screening period
Patients who had their vaccination preponed could enroll in the study only after a gap of 4 weeks after administration of the vaccine. The concomitant use of the following therapies was prohibited except if the dose had been stable for at least 3 months before screening, but study treatment was not to be discontinued in patients receiving the treatments listed below. The doses should have remained stable but were not to be initiated or increased throughout the study.Amitriptyline or other tricyclic or tetracyclic antidepressants
Proportion of patients concomitantly achieving a ≥4-point reduction in WI-NRS with an IGA PN-S of 0 or 1 at week 24 Proportion of patients with IGA PN-S 0 or 1 at week 12 Change from baseline in Skin Pain NRS at week 24 Supportive secondary endpointsProportion of patients with WI-NRS reduction ≥4 at week 4Proportion of patients with IGA PN-S 0 or 1 score at week 8Proportion of patients with IGA PN-A 0 or 1 score at week 24Proportion of patients with IGA PN-A 0 or 1 score at week 8Time to onset...
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