Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00934544 | Primary Myelofibrosis | Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 Baseline, Week 48 | Best Available Therapy (BAT) | 0 Percentage of Participants |
| Ruxolitinib | 28.5 Percentage of Participants | |||
| NCT00952289 | Primary Myelofibrosis | Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 Baseline and Week 24 | Placebo | 1 participants |
| Ruxolitinib | 65 participants | |||
| NCT01243944 | Polycythemia Vera | The Percentage of Participants Achieving a Primary Response at Week 32 32 Weeks | Best Available Therapy | 0.9 percentage of participants |
| Ruxolitinib | 22.7 percentage of participants | |||
| NCT01632904 | Polycythemia Vera | Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary From Baseline to Week 16 | Hydroxyurea | 29.6 Percentage of participants |
| Ruxolitinib | 43.4 Percentage of participants | |||
| NCT01969838 Simplify 1 | Primary Myelofibrosis | Splenic Response Rate at Week 24 Week 24 | Momelotinib (MMB) | 57 Participants |
| Momelotinib (MMB) | 158 Participants | |||
| Ruxolitinib (RUX) | 153 Participants | |||
| Ruxolitinib (RUX) | 64 Participants | |||
| NCT02038036 RESPONSE-2 | Myeloproliferative Disorders | Number of Participants Achieving Hematocrit (Hct) Control at Week 28 Week 28 | Best Available Therapy (BAT) | 14 Participants |
| Ruxolitinib | 46 Participants | |||
| NCT02087059 | Primary Myelofibrosis | Number of Participants With Adverse Events as a Measure of Safety and Tolerability 24 weeks | Ruxolitinib | 33 Participants |
| Ruxolitinib | 46 Participants | |||
| Ruxolitinib | 38 Participants | |||
| Ruxolitinib | 5 Participants | |||
| Ruxolitinib | 33 Participants | |||
| Ruxolitinib | 36 Participants | |||
| Ruxolitinib | 5 Participants | |||
| Ruxolitinib | 50 Participants | |||
| Ruxolitinib | 12 Participants | |||
| NCT02117479 | Pancreatic Neoplasms | Overall Survival (OS) Randomization until death due to any cause; up to the data cutoff 11FEB2016. | Placebo Plus Capecitabine | 124 Participants |
| Placebo Plus Capecitabine | 36 Participants | |||
| Ruxolitinib Plus Capecitabine | 113 Participants | |||
| Ruxolitinib Plus Capecitabine | 48 Participants | |||
| NCT02119663 | Pancreatic Neoplasms | Overall Survival (OS) Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016. | Placebo Plus Capecitabine | 23 Participants |
| Placebo Plus Capecitabine | 20 Participants | |||
| Ruxolitinib Plus Capecitabine | 29 Participants | |||
| Ruxolitinib Plus Capecitabine | 14 Participants | |||
| NCT02292446 | Myeloproliferative Disorders | Number of Participants With Adverse Events - All Grades Baseline up to approximately 26 months | All Patients | 143 Participants |
| All Patients | 26 Participants | |||
| NCT02913261 REACH2 | Graft vs Host Disease | Overall Response Rate (ORR) at Day 28 Day 28 | Best Available Therapy (BAT) | 39.4 Percentage of participants |
| Ruxolitinib (RUX) | 62.3 Percentage of participants | |||
| NCT03112603 | Graft vs Host Disease | Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | Best Available Therapy | 25.6 percentage of participants |
| Ruxolitinib | 49.7 percentage of participants | |||
| NCT03745638 | Dermatitis, Atopic | Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 Baseline to Week 8 | VC Period: Ruxolitinib 0.75% Cream BID | 50.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 53.8 percentage of participants | |||
| VC Period: Vehicle Cream BID | 15.1 percentage of participants | |||
| NCT03745651 | Dermatitis, Atopic | VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 Baseline to Week 8 | VC Period: Ruxolitinib 0.75% Cream BID | 39.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 51.3 percentage of participants | |||
| VC Period: Vehicle Cream BID | 7.6 percentage of participants | |||
| NCT04052425 | Vitiligo | Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 Baseline; Week 24 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 29.8 percentage of participants |
| Double-Blind Period: Vehicle Cream BID | 7.4 percentage of participants | |||
| NCT04057573 | Vitiligo | Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 Baseline; Week 24 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 30.9 percentage of participants |
| Double-Blind Period: Vehicle Cream BID | 11.4 percentage of participants | |||
| NCT04362137 RUXCOVID | COVID-19 | Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care Day 1 - Day 29 | Placebo | 17 Participants |
| Ruxolitinib 5 mg | 34 Participants | |||
| NCT04377620 | COVID-19 | Percentage of Participants Who Have Died Due to Any Cause Study start to Day 29 | Placebo + Standard of Care (SoC) | 70.2 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | 52.9 Percentage | |||
| Ruxolitininb 15mg + Standard of Care (SoC) | 50.6 Percentage | |||
| NCT04472598 TRANSFORM-1 | Primary Myelofibrosis | Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 (SVR35W24) Baseline, Week 24 | Navitoclax + Ruxolitinib | 63.20 percentage of participants |
| Placebo for Navitoclax + Ruxolitinib | 31.50 percentage of participants | |||
| NCT04530344 | Vitiligo | Time to Relapse (Defined as <F-VASI75) from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | Cohort A: Ruxolitinib 1.5% Cream BID | NA days |
| Cohort A: Vehicle Cream BID | NA days | |||
| NCT04551053 | Primary Myelofibrosis | Percentage of Participants Achieving ≥25% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging (MRI) (or Computed Tomography [CT] Scan in Applicable Participants) Baseline; Week 24 | Parsaclisib Plus Ruxolitinib | 16.7 percentage of participants |
| Placebo Plus Ruxolitinib | 9.7 percentage of participants | |||
| NCT04551066 | Primary Myelofibrosis | Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants) Baseline; Week 24 | Parsaclisib Plus Ruxolitinib | 52.8 percentage of participants |
| Placebo Plus Ruxolitinib | 46.7 percentage of participants | |||
| NCT04603495 MANIFEST-2 | Primary Myelofibrosis | Number of Participants With Splenic Response by Central Radiology Reads at Week 24 Week 24 | Pelabresib + Ruxolitinib (Experimental Arm) | 141 Participants |
| Placebo + Ruxolitinib (Control Arm) | 76 Participants | |||
| NCT04921969 | Dermatitis, Atopic | VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 Baseline to Week 8 | VC Period: Ruxolitinib 0.75% Cream BID | 36.6 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 56.5 percentage of participants | |||
| VC Period: Vehicle Cream BID | 10.8 percentage of participants | |||
| NCT04934670 2002 | Lymphoma, Follicular | Complete Response (CR) Day 28 | Ruxolitinib | 0 Participants |
| T-Guard | 2 Participants | |||
| NCT05456529 | Dermatitis, Atopic | Number of Participants With ≥Grade 3 TEAEs up to 462 days | Ruxolitinib 1.5% Cream BID | 3 Participants |
| NCT05456529 | Dermatitis, Atopic | Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 462 days | Ruxolitinib 1.5% Cream BID | 42 Participants |
| NCT05755438 TRuE-PN1 | Skin Diseases | WI-NRS4 Response at Week 12 Baseline; Week 12 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 44.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 20.6 percentage of participants | |||
| NCT05764161 TRuE-PN2 | Skin Diseases | WI-NRS4 Response at Week 12 Baseline; Week 12 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 40.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 36.2 percentage of participants | |||
| NCT06238817 TRuE-AD4 | Dermatitis, Atopic | Percentage of Participants Achieving a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) at Week 8 Baseline; Week 8 | Ruxolitinib 1.5% Cream | 70.0 percentage of participants |
| Vehicle Cream | 18.5 percentage of participants | |||
| NCT06238817 TRuE-AD4 | Dermatitis, Atopic | Percentage of Participants With Investigator's Global Assessment Treatment Success (IGA-TS) at Week 8 Baseline; Week 8 | Ruxolitinib 1.5% Cream | 61.3 percentage of participants |
| Vehicle Cream | 13.6 percentage of participants |