Last updated: 11/10/2025 13:20:08

Relative effectiveness of Ruxolitinib with Momelotinib versus Ruxolitinib alone in JAK-Naïve myelofibrosis participants

GSK study ID
302168
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Matching-Adjusted Indirect Comparison of Ruxolitinib Followed by Momelotinib vs. Ruxolitinib Alone Overall and by RR6 Risk Category in JAK-Naïve Myelofibrosis Patients
Trial description: This is a post hoc analysis study that applies the response to ruxolitinib after 6 months (RR6) model criteria to estimate risk categories for participants with myelofibrosis from SIMPLIFY-1 study and its extended access program (XAP) treated with ruxolitinib followed by momelotinib and compares their overall survival (OS) outcomes with participants of the previous RUXOREL-MF (ruxolitinib alone) study, using matching-adjusted indirect comparison (MAIC) to adjust for potential differences in key prognostic factors.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Overall survival (OS) by using MAIC

Timeframe: Up to approximately 8 years

Secondary outcomes:

Overall survival (OS) by RR6 Risk Categories

Timeframe: Up to approximately 8 years

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2026-01-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Primary Myelofibrosis
Product
Not applicable
Collaborators
None
Study date(s)
December 2025 to March 2026
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Key inclusion criteria for SIMPLIFY-1 + XAP and RUXOREL-MF:
  • Diagnosis of Myelofibrosis as of T -6 Months.
  • Not available
Inclusion and exclusion criteria
Inclusion criteria:

    Key inclusion criteria for SIMPLIFY-1 + XAP and RUXOREL-MF:

    • Diagnosis of Myelofibrosis as of T -6 Months.
    • Follow Up Time Post Time 0 was greater than (>) 0 months.
    • Life Expectancy as of T -6 Months was >24 weeks (only for SIMPLIFY-1 + XAP).
    • Eastern Cooperative Oncology Group (ECOG) as of T -6 Months was lesser than or equal to (<=) 2 (only for SIMPLIFY-1 + XAP).
    • Platelet Count as of T -6 Months was >50*10^9/Liter (L).
    • Palpable Spleen Length as of T -6 Months was greater than or equal to (>=) 5 centimetre (cm).
    • International Prognostic Scoring System (IPSS) as of T -6 Months was intermediate-1 risk or higher.
Exclusion criteria:
  • Not available

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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