A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata
Anderson S, Cavaletti G, Hood L, Polydefkis M, Herrmann D, Rance G, King B, McMichael A, Senna M, Kim B, Napatalung L, Wolk R, Zwillich S, Schaefer G, Gong Y, Sisson M, Posner H. A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata. Pharmacology Research & Perspectives 2024, 12: e1204. PMID: 38969959, PMCID: PMC11226387, DOI: 10.1002/prp2.1204.Peer-Reviewed Original ResearchConceptsIntraepidermal nerve fibersWave V amplitudeInterwave latenciesI-V interwave latencyV amplitudeMonth 9Placebo-controlled phasePhase 2a studyAxonal swellingsIENF densityPlacebo groupBAEP changesLoading doseAdverse eventsRitlecitinibAlopecia areataKinase inhibitorsPrimary outcomeHuman doseToxicity findingsBAEPClinical relevanceNerve fibersPhase 2aStimulus intensityPatient-Reported Satisfaction with Hair Regrowth in a Study of Ritlecitinib in Alopecia Areata: Results from ALLEGRO-2b/3.
Sinclair R, Law E, Zhang X, Zhang F, Napatalung L, Zwillich S, King B, Mesinkovska N. Patient-Reported Satisfaction with Hair Regrowth in a Study of Ritlecitinib in Alopecia Areata: Results from ALLEGRO-2b/3. Dermatology 2024, 1-11. PMID: 38934147, DOI: 10.1159/000539536.Peer-Reviewed Original ResearchPatient-reported satisfactionProportion of patientsAlopecia areataPost hoc analysisPatient satisfactionEvaluate patient-reported satisfactionProportions of placebo patientsHair growthPre-specified analysisScalp hair lossScalp hair growthPatient-reported outcomesEvaluate patient satisfactionPlacebo patientsPlacebo groupRitlecitinibPlaceboHair regrowthPatientsHoc analysisHair lossAA treatmentModerately/veryWeeksPost-hocLong-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata
Piliang M, Soung J, King B, Shapiro J, Rudnicka L, Farrant P, Magnolo N, Piraccini B, Luo X, Woodworth D, Schaefer G, Lejeune A, Wolk R. Long-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata. SKIN The Journal Of Cutaneous Medicine 2024, 8: s394. DOI: 10.25251/skin.8.supp.394.Peer-Reviewed Original ResearchProportion of patientsAlopecia areataResponse ratePhase 3 clinical studiesDaily loading dosesOpen-label studyLong-term efficacyPatient-reported efficacyLong-term safetyScalp hair lossPhase 2b/3Long-term useSevere AAData cutoffLoading dosePGI-CRitlecitinibPatientsHair lossMonthsInterim efficacy resultsAreataEfficacyAlopeciaPhase 3Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program
King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska N, Paul C, Gong Y, Anway S, Tran H, Wolk R, Zwillich S, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. American Journal Of Clinical Dermatology 2024, 25: 299-314. PMID: 38263353, PMCID: PMC10867086, DOI: 10.1007/s40257-024-00846-3.Peer-Reviewed Original ResearchConceptsAdverse eventsAlopecia areataIncidence rateKinase inhibitorsTreatment of alopecia areataPlacebo-controlled cohortAdverse cardiovascular eventsClinical trial programIntegrated safety analysisOpportunistic infectionsPlacebo groupPlacebo-controlledLaboratory abnormalitiesHerpes zosterSafety profileSevere acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Cardiovascular eventsRespiratory syndrome coronavirus 2RitlecitinibObjectiveThe objectivePhase 2aTrial programPatientsMethodsTwo cohorts