NCT01369498 is a Phase 2 clinical trial of Simtuzumab in Myelofibrosis, sponsored by Gilead Sciences.

Who is sponsoring NCT01369498?

NCT01369498 is sponsored by Gilead Sciences.

What drugs are being tested in NCT01369498?

Interventions in NCT01369498: Simtuzumab, Ruxolitinib.

What condition does NCT01369498 study?

NCT01369498 studies Myelofibrosis.

Is NCT01369498 still recruiting?

NCT01369498 is currently completed. Last updated 1 July 2020.

Are results published for NCT01369498?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-01 · How we verify

NCT01369498

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

Completed Phase 2 Results posted Last updated 1 July 2020

What this trial tests

Phase 2 trial testing Simtuzumab in Myelofibrosis in 54 participants. Completed in 24 September 2014.

Timeline

30 June 2011

Primary endpoint
5 June 2014

24 September 2014

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	30 June 2011
Primary completion	5 June 2014
Estimated completion	24 September 2014
Sites	7 locations across United States

Drugs / interventions tested

Simtuzumab — full drug profile →
Ruxolitinib (RUXOLITINIB) — full drug profile →

Conditions studied

Myelofibrosis — all drugs for Myelofibrosis →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Myelofibrosis. 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.

Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score Primary · Baseline; Week 24

Overall response for the study drug is defined by the reduction in bone marrow fibrosis score which is on a scale of 0-3 where 0 indicates the scattered linear reticulin with no fiber intersections representing normal marrow and 3 indicates dense increase in reticulin fibrosis with fiber intersections, often with osteosclerosis. Reduction from baseline of score indicates improvement in clinical condition.

Group	Value	95% CI
Stage 1: SIM 200 mg	0	0.0 – 23.8
Stage 1: SIM 700 mg	16.7	3.0 – 43.8
Stage 2: SIM 200 mg+Ruxolitinib	6.7	0.3 – 27.9
Stage 2: SIM 700 mg+Ruxolitinib	13.3	2.4 – 36.3

Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) Secondary · Baseline; Weeks 12, 24 and any time post baseline (enrollment up to 94 weeks)

Overall response for the study drug was defined by the rate of clinical improvement in hemoglobin, platelet or ANC. Clinical improvement in hemoglobin was defined as a ≥ 2 g/dL increase from baseline in hemoglobin level and transfusion independent (absence of red blood cell (RBC) transfusions in prior 8 weeks and applicable only for participants with baseline hemoglobin level of \< 10 g/dL); clinical improvement in platelets was defined as a ≥ 100% increase from baseline in platelet count and an absolute platelet count of ≥ 50 x 10\^9/L (applicable only for participants with baseline platelet

Week 12

Group	Value	95% CI
Stage 1: SIM 200 mg	0	0.0 – 25.9
Stage 1: SIM 700 mg	0	0.0 – 25.9
Stage 2: SIM 200 mg+Ruxolitinib	0	0.0 – 28.3
Stage 2: SIM 700 mg+Ruxolitinib	0	0.0 – 25.9

Week 24

Group	Value	95% CI
Stage 1: SIM 200 mg	0	0.0 – 25.9
Stage 1: SIM 700 mg	0	0.0 – 25.9
Stage 2: SIM 200 mg+Ruxolitinib	0	0.0 – 28.3
Stage 2: SIM 700 mg+Ruxolitinib	0	0.0 – 25.9

Any Time Post-Baseline

Group	Value	95% CI
Stage 1: SIM 200 mg	0	0.0 – 25.9
Stage 1: SIM 700 mg	0	0.0 – 25.9
Stage 2: SIM 200 mg+Ruxolitinib	11.1	0.6 – 42.9
Stage 2: SIM 700 mg+Ruxolitinib	0	0.0 – 25.9

Percentage of Participants With Adverse Events (AEs) Secondary · First dose date up to the last dose date (maximum: 94 weeks) plus 28 days

Group	Value	95% CI
Stage 1: SIM 200 mg	100
Stage 1: SIM 700 mg	100
Stage 2: SIM 200 mg+Ruxolitinib	100
Stage 2: SIM 700 mg+Ruxolitinib	100

Change From Baseline in Myelofibrosis Symptoms Assessment Score Secondary · Baseline; Days 43 and 85 of Cycles 1-7 (cycle=12 weeks)

Myelofibrosis symptom assessment was performed using myeloproliferative neoplasm symptoms assessment form (MPN-SAF) which is a 27-item questionnaire to address symptom burden and quality of life. The form consists of 27 questions which are scored on a scale of 0-10 by participants based on how symptoms are affecting them, where 0 indicates less symptoms while 10 indicated more severe symptoms and greater inactivity. The MPN-SAF score was calculated at each visit for each participant as an average of the scales for each question and all answered questions. If the number of questions not answere

Baseline

Group	Value	95% CI
Stage 1: SIM 200 mg	2.5	± 1.75
Stage 1: SIM 700 mg	3.7	± 1.86
Stage 2: SIM 200 mg+Ruxolitinib	3.2	± 2.06
Stage 2: SIM 700 mg+Ruxolitinib	2.2	± 1.34

Best Change from Baseline

Group	Value	95% CI
Stage 1: SIM 200 mg	-0.9	± 1.11
Stage 1: SIM 700 mg	-1.3	± 1.60
Stage 2: SIM 200 mg+Ruxolitinib	-1.1	± 1.25
Stage 2: SIM 700 mg+Ruxolitinib	-0.6	± 0.98

Change from Baseline at Cycle 1 - Day 43

Group	Value	95% CI
Stage 1: SIM 200 mg	-0.2	± 0.58
Stage 1: SIM 700 mg	-1.0	± 1.66
Stage 2: SIM 200 mg+Ruxolitinib	-0.2	± 0.81
Stage 2: SIM 700 mg+Ruxolitinib	0.2	± 1.00

Change from Baseline at Cycle 1 - Day 85

Group	Value	95% CI
Stage 1: SIM 200 mg	-0.3	± 1.59
Stage 1: SIM 700 mg	-0.9	± 1.67
Stage 2: SIM 200 mg+Ruxolitinib	0.5	± 1.36
Stage 2: SIM 700 mg+Ruxolitinib	0.4	± 0.74

Change from Baseline at Cycle 2 - Day 43

Group	Value	95% CI
Stage 1: SIM 200 mg	-0.3	± 0.99
Stage 1: SIM 700 mg	-1.0	± 1.26
Stage 2: SIM 200 mg+Ruxolitinib	-0.7	± 1.30
Stage 2: SIM 700 mg+Ruxolitinib	0.4	± 1.43

Change from Baseline at Cycle 2 - Day 85

Group	Value	95% CI
Stage 1: SIM 200 mg	0.3	± 0.89
Stage 1: SIM 700 mg	-0.8	± 1.44
Stage 2: SIM 200 mg+Ruxolitinib	-0.5	± 1.42
Stage 2: SIM 700 mg+Ruxolitinib	0.7	± 1.61

Change from Baseline at Cycle 3 - Day 43

Group	Value	95% CI
Stage 1: SIM 200 mg	1.1	± 2.81
Stage 1: SIM 700 mg	-1.2	± 2.33
Stage 2: SIM 200 mg+Ruxolitinib	-0.5	± 1.16
Stage 2: SIM 700 mg+Ruxolitinib	-0.3	± 0.58

Change from Baseline at Cycle 3 - Day 85

Group	Value	95% CI
Stage 1: SIM 200 mg	0.1	± 1.10
Stage 1: SIM 700 mg	0.6	± 1.55
Stage 2: SIM 200 mg+Ruxolitinib	-0.5	± 1.22
Stage 2: SIM 700 mg+Ruxolitinib	-0.8	± 0.39

Percentage of Participants With Anti-Simtuzumab Antibody Formation Secondary · Baseline; Day 85 of Cycles 1 to 5 (cycle=12 weeks)

Blood samples were collected for the presence of anti-SIM antibodies which was determined using a validated electro-chemiluminescent (ECL) assay screening test.

Baseline : Screened Negative

Group	Value	95% CI
Stage 1: SIM 200 mg	75.0
Stage 1: SIM 700 mg	63.6
Stage 2: SIM 200 mg+Ruxolitinib	73.3
Stage 2: SIM 700 mg+Ruxolitinib	78.6

Baseline : Screened Positive

Group	Value	95% CI
Stage 1: SIM 200 mg	25.0
Stage 1: SIM 700 mg	36.4
Stage 2: SIM 200 mg+Ruxolitinib	26.7
Stage 2: SIM 700 mg+Ruxolitinib	21.4

Cycle 1 - Day 85 : Screened Negative

Group	Value	95% CI
Stage 1: SIM 200 mg	100.0
Stage 1: SIM 700 mg	90.0
Stage 2: SIM 200 mg+Ruxolitinib	57.1
Stage 2: SIM 700 mg+Ruxolitinib	92.3

Cycle 1 - Day 85 : Screened Positive

Group	Value	95% CI
Stage 1: SIM 200 mg	0
Stage 1: SIM 700 mg	10.0
Stage 2: SIM 200 mg+Ruxolitinib	42.9
Stage 2: SIM 700 mg+Ruxolitinib	7.7

Cycle 2 - Day 85 : Screened Negative

Group	Value	95% CI
Stage 1: SIM 200 mg	100.0
Stage 1: SIM 700 mg	85.7
Stage 2: SIM 200 mg+Ruxolitinib	69.2
Stage 2: SIM 700 mg+Ruxolitinib	90.9

Cycle 2 - Day 85 : Screened Positive

Group	Value	95% CI
Stage 1: SIM 200 mg	0
Stage 1: SIM 700 mg	14.3
Stage 2: SIM 200 mg+Ruxolitinib	30.8
Stage 2: SIM 700 mg+Ruxolitinib	9.1

Cycle 3 - Day 85 : Screened Negative

Group	Value	95% CI
Stage 1: SIM 200 mg	100.0
Stage 1: SIM 700 mg	100.0
Stage 2: SIM 200 mg+Ruxolitinib	100.0
Stage 2: SIM 700 mg+Ruxolitinib	75.0

Cycle 3 - Day 85 : Screened Positive

Group	Value	95% CI
Stage 1: SIM 200 mg	0
Stage 1: SIM 700 mg	0
Stage 2: SIM 200 mg+Ruxolitinib	0
Stage 2: SIM 700 mg+Ruxolitinib	25.0

Adverse events — posted to ClinicalTrials.gov

Time frame: First dose date up to the last dose date (maximum: 94 weeks) plus 28 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stage 1: SIM 200 mg

Serious: 8/12 (67%)

Deaths: 0/12

Stage 1: SIM 700 mg

Serious: 1/12 (8%)

Deaths: 1/12

Stage 2: SIM 200 mg+Ruxolitinib

Serious: 5/15 (33%)

Deaths: 1/15

Stage 2: SIM 700 mg+Ruxolitinib

Serious: 4/15 (27%)

Deaths: 0/15

Serious adverse events (36 terms)

Reaction	System	Stage 1: SIM 200 mg	Stage 1: SIM 700 mg	Stage 2: SIM 200 mg+Ruxoli…	Stage 2: SIM 700 mg+Ruxoli…
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Disease progression	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Bile duct stone	Hepatobiliary disorders	—	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—	—
Abdominal infection	Infections and infestations	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—
Periorbital infection	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—
Troponin increased	Investigations	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Haemarthrosis	Musculoskeletal and connective tissue disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—

Other adverse events (266 terms — click to expand)

Reaction	System	Stage 1: SIM 200 mg	Stage 1: SIM 700 mg	Stage 2: SIM 200 mg+Ruxoli…	Stage 2: SIM 700 mg+Ruxoli…
Fatigue	General disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—
Nocturia	Renal and urinary disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—
Faecal incontinence	Gastrointestinal disorders	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Early satiety	General disorders	—	—	—	—

Most-reported serious reactions: Febrile neutropenia, Diarrhoea, Disease progression, Pyrexia, Bile duct stone, Cholecystitis, Abdominal infection, Cellulitis.

Data from ClinicalTrials.gov NCT01369498 adverse events section.

Sponsor's own description

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF). The study is designed as a two-stage trial. In the stage 1, participants will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, participants on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting extracellular matrix stiffness and mechanotransducers to improve cancer therapy.
Jiang Y, Zhang H, Wang J, Liu Y, et al · · 2022 · cited 342× · PMID 35331296 · DOI 10.1186/s13045-022-01252-0
Bone marrow fibrosis in myelofibrosis: pathogenesis, prognosis and targeted strategies.
Zahr AA, Salama ME, Carreau N, Tremblay D, et al · · 2016 · cited 129× · PMID 27252511 · DOI 10.3324/haematol.2015.141283
Megakaryocyte pathology and bone marrow fibrosis: the lysyl oxidase connection.
Papadantonakis N, Matsuura S, Ravid K. · · 2012 · cited 62× · PMID 22767499 · DOI 10.1182/blood-2012-02-402594
Extracellular matrix dynamics in tumor immunoregulation: from tumor microenvironment to immunotherapy.
Hu Q, Zhu Y, Mei J, Liu Y, et al · · 2025 · cited 54× · PMID 40537775 · DOI 10.1186/s13045-025-01717-y
Ruxolitinib in combination with lenalidomide as therapy for patients with myelofibrosis.
Daver N, Cortes J, Newberry K, Jabbour E, et al · · 2015 · cited 47× · PMID 26088933 · DOI 10.3324/haematol.2015.126821
Targeting extracellular matrix stiffness for cancer therapy.
Feng X, Cao F, Wu X, Xie W, et al · · 2024 · cited 29× · PMID 39697341 · DOI 10.3389/fimmu.2024.1467602
Inflammatory Microenvironment and Specific T Cells in Myeloproliferative Neoplasms: Immunopathogenesis and Novel Immunotherapies.
Nasillo V, Riva G, Paolini A, Forghieri F, et al · · 2021 · cited 28× · PMID 33672997 · DOI 10.3390/ijms22041906
Guidelines for the management of myeloproliferative neoplasms.
Choi CW, Bang SM, Jang S, Jung CW, et al · · 2015 · cited 18× · PMID 26552452 · DOI 10.3904/kjim.2015.30.6.771

Verify or expand the search:

Other trials of Simtuzumab

Trials testing the same drug.

NCT01672853 — Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (P · Phase 2 · completed
NCT01769196 — Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · terminated
NCT01759511 — Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · terminated
NCT01707472 — Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis · Phase 2 · completed

Other recruiting trials for Myelofibrosis

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06781099 — Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis · NA · recruiting
NCT07362225 — MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myel · recruiting
NCT07342712 — Clinical Trail to Evaluate the Effect of Long-term Treatment With Gecacitinib on Myelofibrosis and Gene Mutation Levels · active not recruiting
NCT06533813 — Clinical Epidemiology in Contemporary Patients With Myelofibrosis. · recruiting

Other Gilead Sciences trials

Trials by the same sponsor.

NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01369498 (US National Library of Medicine, public domain)
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 Gilead Sciences
Last refreshed: 1 July 2020

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/NCT01369498.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing