2024
Renew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS)
Komrokji R, Diez-Campelo M, Chee L, Cluzeau T, DeZern A, Fenaux P, Garcia-Manero G, Giagounidis A, Platzbecker U, Della Porta M, Santini V, Sekeres M, Zeidan A, Buckstein R, Ross M, Jiang Y, Bobba S, Hankin M, Materna C, Graham C, Thamake S, Rovaldi C, Grayson D, Salstrom J. Renew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS). Blood 2024, 144: 3228.1-3228.1. DOI: 10.1182/blood-2024-200797.Peer-Reviewed Original ResearchDurability of responseMyelodysplastic neoplasmsFollow-up periodTransfusion burdenProportion of participantsAdverse eventsTransfusion independenceIneffective hematopoiesisDouble-blindPlacebo-controlled phase 3 studyAchievement of transfusion independenceMultiple stages of hematopoiesisSafety follow-up periodDouble-blind treatment periodLong-term follow-up periodSeverity of adverse eventsLong-term follow-upErythroid maturation agentLow transfusion burdenSustained hematologic improvementTreatment of transfusion-dependent anemiaPlacebo-controlled studyTransfusion-dependent anemiaPhase 3 studyProgression to AML
2018
Decreased Rescue Analgesic Use with Elagolix Treatment in Women with Endometriosis-Associated Pain [35G]
Taylor H, Diamond M, Surrey E, Schwefel B, Snabes M, Peloso P. Decreased Rescue Analgesic Use with Elagolix Treatment in Women with Endometriosis-Associated Pain [35G]. Obstetrics And Gynecology 2018, 131: 84s-85s. DOI: 10.1097/01.aog.0000533583.86343.77.Peer-Reviewed Original ResearchRescue analgesic useEndometriosis-associated painSevere endometriosis-associated painPhase 3 studyAnalgesic usePill countElagolix treatmentPlacebo-controlled phase 3 studyNonmenstrual pelvic painMean percent decreaseElagolix dosesSingle opioidPelvic painOpioid pillsDose groupPainPlaceboPercent changeWomenGreater decreaseBaselinePercent decreaseElagolixTreatmentDoses
2017
LBA4_PR RANGE: A randomized, double-blind, placebo-controlled phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma
Petrylak D, Chi K, Drakaki A, Sternberg C, de Wit R, Nishiyama H, Yu E, Castellano D, Hussain S, Percent I, Fléchon A, Bamias A, van der Heijden M, Matsubara N, Alekseev B, Walgren R, Hamid O, Zimmermann A, Bell-Mcguinn K, Powles T. LBA4_PR RANGE: A randomized, double-blind, placebo-controlled phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma. Annals Of Oncology 2017, 28: v621. DOI: 10.1093/annonc/mdx440.028.Peer-Reviewed Original ResearchPlacebo-controlled phase 3 studyMetastatic urothelial carcinomaPhase 3 studyUrothelial carcinomaRamucirumabDocetaxel
2015
134 Peyronie's disease symptom bother reduction is related to penile curvature improvement in response to treatment with collagenase clostridium histolyticum: Results from two large double-blind, randomized, placebo-controlled phase 3 studies
Lipshultz L, Sadeghi-Nejad H, Mills J, Tursi J, Smith T, Kaufman G, Liu G, Honig S. 134 Peyronie's disease symptom bother reduction is related to penile curvature improvement in response to treatment with collagenase clostridium histolyticum: Results from two large double-blind, randomized, placebo-controlled phase 3 studies. European Urology Open Science 2015, 14: e134. DOI: 10.1016/s1569-9056(15)60136-1.Peer-Reviewed Original ResearchPlacebo-controlled phase 3 studyPhase 3 studyCollagenase clostridium histolyticumCurvature improvementClostridium histolyticum
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