itacitinib immediate release (INCB039110 IR) / Incyte - LARVOL DELTA

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) (clinicaltrials.gov) - P2 | N=4 | Completed | Sponsor: Incyte Corporation | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: May 2023 ➔ Sep 2023 | Trial primary completion date: May 2023 ➔ Sep 2023

Monotherapy • Trial completion date • Trial primary completion date • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Dec 2022 ➔ May 2023 | Trial primary completion date: Dec 2022 ➔ May 2023

Monotherapy • Trial completion date • Trial primary completion date • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Jul 2024 ➔ Dec 2022

Monotherapy • Trial completion date • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | N=73 ➔ 4

Enrollment change • Enrollment closed • Monotherapy • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis

[VIRTUAL] A Two-Part Phase 2 Study of Itacitinib Immediate Release in Patients with Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (AACR 2021) - P2 | "Secondary objectives (part 2 only): evaluate safety and tolerability of itacitinib IR; evaluate efficacy of itacitinib IR with respect to MF symptom improvement at week 24 in patients with baseline total symptom score ≥10, quality-of-life improvement, and patient global impression of change. Sites are opening in the US and EU."

Clinical • Monotherapy • P2 data • Myelofibrosis • Oncology • Polycythemia Vera

[VIRTUAL] A TWO-PART PHASE 2 STUDY OF ITACITINIB IMMEDIATE RELEASE IN PATIENTS WITH PRIMARY OR SECONDARY MYELOFIBROSIS WHO HAVE RECEIVED PRIOR RUXOLITINIB AND/OR FEDRATINIB MONOTHERAPY (EHA 2021) - P2 | "Sites are opening in the United States and Europe. Results Not applicable Conclusion Not applicable"

Clinical • Monotherapy • P2 data • Hematological Disorders • Myelofibrosis • Polycythemia Vera • Thrombocytosis

[VIRTUAL] A Two-Part Phase 2 Study of Itacitinib Immediate Release in Patients with Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (BSH 2021) - P2 | "Secondary objectives (part 2 only): evaluate safety and tolerability of itacitinib IR; evaluate efficacy of itacitinib IR with respect to MF symptom improvement at week 24 in patients with baseline total symptom score ≥10, quality-of-life improvement, and patient global impression of change. Sites are opening in the US and EU."

Clinical • Monotherapy • P2 data • Myelofibrosis • Thrombocytosis

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) (clinicaltrials.gov) - P2; N=73; Recruiting; Sponsor: Incyte Corporation; Trial completion date: Dec 2023 ➔ Jul 2024; Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Myelofibrosis • Polycythemia Vera • Thrombocytosis • MRI

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) (clinicaltrials.gov) - P2; N=73; Not yet recruiting; Sponsor: Incyte Corporation; Trial completion date: Feb 2023 ➔ Dec 2023

Clinical • Monotherapy • Trial completion date • Myelofibrosis • Polycythemia Vera • Thrombocytosis • MRI

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy. (LIMBER-213) (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Incyte Corporation

New P2 trial • Myelofibrosis • Polycythemia Vera • Thrombocytosis • MRI

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy. (clinicaltrials.gov) - P2; N=73; Recruiting; Sponsor: Incyte Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Monotherapy • Myelofibrosis • Polycythemia Vera • Thrombocytosis