18 and older, any sex, with Myelofibrosis With High Molecular Risk Mutations. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage Change in Spleen Volume From BaselineSecondary· From baseline and assessed on 12 week intervals until end of treatment (EOT)
Change in spleen volume (by MRI/CT) from baseline
Week 12
Group
Value
95% CI
Ruxolitinib (INC424)
-10.8
± 24.45
Ruxolitinib Placebo
9.1
± 12.34
Week 24
Group
Value
95% CI
Ruxolitinib (INC424)
-17.8
± 18.83
Ruxolitinib Placebo
17.6
± 17.78
Week 36
Group
Value
95% CI
Ruxolitinib (INC424)
-18.4
± 31.62
Ruxolitinib Placebo
32.5
± 18.81
Week 48
Group
Value
95% CI
Ruxolitinib (INC424)
-23.5
± 10.57
End of Treatment (EOT)
Group
Value
95% CI
Ruxolitinib (INC424)
-11.6
± 8.08
Ruxolitinib Placebo
18.1
± 18.58
Percentage Change in Symptoms From Baseline Using MF-7Secondary· From Baseline and assessed every 4 weeks until end of treatment
Percentage change from Baseline in MF-7 total symptom score and 7 individual symptoms at each visit was summarized with descriptive statistics. For this scale, symptoms range from 0 to 10 for the severity experienced within the past 24 hours, with 0 being for absence of symptoms and 10 for worst imaginable symptoms.
Total Score derived (TSD): Baseline (BL)
Group
Value
95% CI
Ruxolitinib (INC424)
6.6
± 5.17
Ruxolitinib Placebo
5.9
± 5.56
TSD change from baseline @ W12
Group
Value
95% CI
Ruxolitinib (INC424)
-0.3
± 4.45
Ruxolitinib Placebo
0.5
± 6.08
TSD change from baseline @ W24
Group
Value
95% CI
Ruxolitinib (INC424)
0.5
± 3.71
Ruxolitinib Placebo
-0.8
± 6.44
TSD change from baseline @ W48
Group
Value
95% CI
Ruxolitinib (INC424)
-0.3
± 3.06
TSD change from BL @ EOT
Group
Value
95% CI
Ruxolitinib (INC424)
1.1
± 4.40
Ruxolitinib Placebo
3.3
± 9.53
Tiredness: Baseline (BL)
Group
Value
95% CI
Ruxolitinib (INC424)
1.8
± 1.45
Ruxolitinib Placebo
1.5
± 1.53
Tiredness: change from baseline @ W12
Group
Value
95% CI
Ruxolitinib (INC424)
0.1
± 1.47
Ruxolitinib Placebo
0.4
± 1.27
Tiredness: change from baseline @ W24
Group
Value
95% CI
Ruxolitinib (INC424)
-0.1
± 0.76
Ruxolitinib Placebo
1.1
± 2.52
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5DSecondary· From Baseline and assessed every 4 weeks until end of treatment
EQ-ED5 profiles were summarized at baseline and at each scheduled assessment for each of the 5 dimensions separately (Mobility, self-care, usual activities, pain discomfort, anxiety/depression) Only participants with baseline score and at least one non-missing post-baseline score during the treatment period were included. Percentages were based on all these evaluable participants.
The 5 scores for mobility, self-care, usual activities, pain/discomfort and anxiety/depression are all self-explanatory (eg "I have no problems walking" to "I am unable to walk"), except for the following overall he
Mobility- Baseline: No problem
Group
Value
95% CI
Ruxolitinib (INC424)
17
Ruxolitinib Placebo
18
Mobility- Baseline: Slight problems
Group
Value
95% CI
Ruxolitinib (INC424)
4
Ruxolitinib Placebo
5
Mobility- Baseline: Moderate problems
Group
Value
95% CI
Ruxolitinib (INC424)
1
Ruxolitinib Placebo
1
Mobility- Baseline: Extreme problems
Group
Value
95% CI
Ruxolitinib (INC424)
1
Ruxolitinib Placebo
0
Mobility - Week 4:No prob.
Group
Value
95% CI
Ruxolitinib (INC424)
17
Ruxolitinib Placebo
14
Mobility - Week 4: Slight problems
Group
Value
95% CI
Ruxolitinib (INC424)
4
Ruxolitinib Placebo
7
Mobility - Week 4: Moderate problems
Group
Value
95% CI
Ruxolitinib (INC424)
1
Ruxolitinib Placebo
2
Mobility - Week 8: No problem
Group
Value
95% CI
Ruxolitinib (INC424)
17
Ruxolitinib Placebo
15
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ruxolitinib (INC424)
Serious: 2/24 (8%)
Deaths: 0/24
Ruxolitinib Placebo
Serious: 1/24 (4%)
Deaths: 0/24
Serious adverse events (3 terms)
Reaction
System
Ruxolitinib (INC424)
Ruxolitinib Placebo
Tendon rupture
Injury, poisoning and procedural complications
—
—
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07498205 — Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
· Phase 4
· not yet recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (
· Phase 2
· recruiting
NCT07311746 — Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07340138 — Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
· Phase 1
· not yet recruiting
NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
· Phase 1
· not yet recruiting
Other recruiting trials for Myelofibrosis With High Molecular Risk Mutations
Currently open trials in the same condition.
NCT07362225 — MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myel
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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· Phase 4
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NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
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NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
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NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 16 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02598297.