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To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

NCT04551053 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2025-10-02

Study results available
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Summary

The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.

Conditions

  • Myelofibrosis
  • Primary Myelofibrosis
  • Post Essential Thrombocythemia Myelofibrosis
  • Post Polycythemia Vera Myelofibrosis

Interventions

DRUG

parsaclisib

parsaclisib will be administered QD orally

DRUG

ruxolitinib

ruxolitinib will be administered BID orally

DRUG

placebo

placebo will be administered QD orally

Sponsors & Collaborators

Principal Investigators

  • Albert Assad, M.D. · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2023-08-16
Completion
2024-08-21
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • China
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Norway
  • Poland
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04551053 on ClinicalTrials.gov