Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Phase 1/2 Terminated 45 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to investigate the safety, pharmacokinetics and preliminary efficacy of combination treatment of ruxolitinib with 5 novel compounds: siremadlin, crizanlizumab, sabatolimab, rineterkib and NIS793 in myelofibrosis (MF) subjects.

Timeline

Start: 2019-09-26
Primary completion: 2023-05-03
Completion: 2024-08-28

Outcome

Outcome not reported

Stopped (Business): “Sponsor Decision”

Publications

Ross DM, Heidel FH, Perkins AC, Reiter A, Crodel C, Riley C, Gomez-Casares MT, Takacs I, Becker H, Lehmann T, Vinogradova O, Burbury K, Vannucchi AM, Gupta V, Wondergem M, Kiladjian JJ, Cleary G, Zhang A, Kota J, Prahallad A, Wroclawska M, Lu M, Harrison CN. ADORE: an open platform study of ruxolitinib in combination with other novel therapies in patients with myelofibrosis. Blood Adv. 2025 Aug 26;9(16):4195-4205. doi: 10.1182/bloodadvances.2025015860.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Crizanlizumab	Monoclonal antibody	—	Intravenous
Subject	NISEVOKITUG	Monoclonal antibody	—	Intravenous
Subject	Rineterkib	Unknown	200 mg	Oral
Subject	Sabatolimab	Monoclonal antibody	—	Intravenous
Subject	Siremadlin	Small molecule	20 mg	Oral
Subject	Siremadlin	Small molecule	30 mg	Oral
Subject	Siremadlin	Small molecule	40 mg	Oral
Background	Ruxolitinib	Small molecule	—	Oral