NCT03491215 is a Phase 1, PHASE2 clinical trial of Ruxolitinib in Acute Graft Versus Host Disease, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT03491215?

NCT03491215 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03491215?

Interventions in NCT03491215: Ruxolitinib.

What condition does NCT03491215 study?

NCT03491215 studies Acute Graft Versus Host Disease.

Is NCT03491215 still recruiting?

NCT03491215 is currently completed. Last updated 4 May 2025.

Are results published for NCT03491215?

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

Last reviewed 2025-05-04 · How we verify

NCT03491215

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

Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease

Completed Phase 1, PHASE2 Results posted Last updated 4 May 2025

What this trial tests

Phase 1, PHASE2 trial testing Ruxolitinib in Acute Graft Versus Host Disease in 45 participants. Completed in 2 February 2023.

Timeline

21 February 2019

Primary endpoint
11 March 2021

2 February 2023

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	21 February 2019
Primary completion	11 March 2021
Estimated completion	2 February 2023
Sites	19 locations across Denmark, France, Italy, Japan, Belgium, South Korea, Canada, Spain

Drugs / interventions tested

Ruxolitinib (RUXOLITINIB) — full drug profile →

Conditions studied

Acute Graft Versus Host Disease — all drugs for Acute Graft Versus Host Disease →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 28 Days to 17, any sex, with Acute Graft Versus Host Disease. 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.

Phase I: Measurement of Pharmacokinetic (PK) Parameter, AUClast, in aGvHD and SR-aGvHD Patients Primary · Day 1: at predose, 0.5,1,1.5, 2, 4, 6, 9 hours post dose

Measurement in acute GvHD and SR-acute GvHD subjects used extensive PK sampling in Groups 1-3 sparse sampling in Group 4. AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast).

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID Tablet	252	± 186.6
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Tablet	372	± 58.6
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Capsule	154	± 58.1
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Capsule	239	± 65.3
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Liquid	259	± 53.6

Phase I: Measurement of PK Parameter, Cmax, in aGvHD and SR-aGvHD Patients Primary · Day 1: at predose, 0.5,1,1.5, 2, 4, 6, 9 hours post dose

Measurement in acute GvHD and SR-acute GvHD subjects used extensive PK sampling in Groups 1-3 and sparse sampling in Group 4. Cmax: The maximum (peak) observed plasma drug concentration

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID Tablet	66.1	± 169.8
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Tablet	105	± 71.4
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Capsule	49.4	± 45.7
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Capsule	61.2	± 81.1
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Liquid	66.5	± 60.8

Phase I: Measurement of PK Parameter, T1/2, in aGvHD and SR-aGvHD Patients Primary · Day 1: at predose, 0.5,1,1.5, 2, 4, 6, 9 hours post dose

Measurement in acute GvHD and SR-acute GvHD subjects used extensive PK sampling in Groups 1-3 and sparse sampling in Group 4. T1/2: The elimination half-life associated with the terminal slope (Lambda\_z ) of a semi logarithmic concentration-time curve

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID Tablet	1.33	± 31.7
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Tablet	1.66	± 17.5
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Capsule	1.50	± 6.5
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Capsule	1.86	± 29.9
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Liquid	1.78	± 66.3

Phase I: Measurement of PK Parameter, Ctrough, in aGvHD and SR-aGvHD Patients Primary · Day 7 at pre-dose

Measurement in acute GvHD and SR-acute GvHD subjects used extensive PK sampling in Groups 1-3 and sparse sampling in Group 4. Ctrough: The minimum observed plasma concentration at the end of an administration interval (corresponding to the pre-dose concentration prior to the following administration).

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID Tablet	9.27	± 379.4
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Tablet	9.75	± 255.5
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Capsule	1.71	± 1.2
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Capsule	6.18	± 195.8
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Liquid	3.99	± 277.1

Phase I: Age-based Determination of Recommended Phase 2 Dose (RP2D) Using AUClast Primary · Day 1: at predose, 0.5,1,1.5, 2, 4, 6, 9 hours post dose

Phase I: Age-based determination of RP2D in Groups 2 and 3 and was based on observed PK parameters in Groups 1-3 * Group 2: age ≥ 6 to \< 12 years * Group 3: age ≥ 2 to \< 6 years AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast).

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID Tablet	252	± 186.6
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Capsule	154	± 58.1
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Tablet	372	± 58.6
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Capsule	239	± 65.3
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Liquid	259	± 53.6

Phase I: Age-based Determination of Recommended Phase 2 Dose (RP2D) Using Cmax Primary · Day 1: at predose, 0.5,1,1.5, 2, 4, 6, 9 hours post dose

Phase I: Age-based determination of RP2D in Groups 2 and 3 and was based on observed PK parameters in Groups 1-3 * Group 2: age ≥ 6 to \< 12 years * Group 3: age ≥ 2 to \< 6 years Cmax: The maximum (peak) observed plasma drug concentration.

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID Tablet	66.1	± 169.8
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Capsule	49.4	± 45.7
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Tablet	105	± 71.4
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Capsule	61.2	± 81.1
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Liquid	66.5	± 60.8

Phase I: Age-based Determination of Recommended Phase 2 Dose (RP2D) Using Ctrough Primary · Day 7 at pre-dose

Phase I: Age-based determination of RP2D in Groups 2 and 3 and was based on observed PK parameters in Groups 1-3 * Group 2: age ≥ 6 to \< 12 years * Group 3: age ≥ 2 to \< 6 years Ctrough: The minimum observed plasma concentration at the end of an administration interval (corresponding to the pre-dose concentration prior to the following administration).

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID Tablet	8.85	± 538.6
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Capsule	1.71	± 1.2
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID Tablet	10.6	± 208.1
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Capsule	6.18	± 195.8
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID Liquid	3.99	± 277.1

Phase II: Overall Response Rate (ORR) Primary · Day 28

Phase II: ORR is defined as the percentage of patients demonstrating a complete response (CR) or partial response (PR) without requirement for additional systemic therapies for an earlier progression, mixed response or non-response. Scoring of response was relative to the organ stage at the start of the study treatment. Complete response (CR) is defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapy for any earlier progression, mixe

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID	83.3	62.3 – 95.3
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID	83.3	56.2 – 97.0
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID	86.7	63.7 – 97.6

Percentage of All Patients Who Achieved a Complete Response (CR) or Partial Response (PR) (Durable Overall Response Rate (ORR)) Secondary · Day 56

Durable ORR at Day 56 was defined as the percentage of all subjects who achieved a complete response (CR) or partial response (PR) at Day 28 and maintained a CR or PR at Day 56. Complete-response was defined as a score of 0 for the acute GvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of acute GvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of acute GvHD. Partial response was defined as improvement of 1 stage in 1 or more organs involved with acut

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID	55.6	34.1 – 75.6
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID	75.0	47.3 – 92.8
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID	73.3	48.9 – 90.3

Percentage of Patients Who Achieved OR (CR+PR) at Day 14 Secondary · Day 14

ORR at Day 14 was defined as the percentage of participants with complete response (CR) or partial response (PR ) at Day 14 according to standard criteria. Complete response (CR) is defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapy for any earlier progression, mixed response or non-response of aGvHD. Partial response (PR) is defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without pro

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID	72.2	50.2 – 88.4
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID	66.7	39.1 – 87.7
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID	86.7	63.7 – 97.6

Area Under the Curve (AUClast) Versus Efficacy: Impact of AUClast on Overall Response Rate (ORR) at Day 28 Secondary · Day 28

To assess pharmacokinetic/pharmacodynamic relationship (comparison of AUClast with ORR at day 28). ORR is the percentage of patients with a complete response (CR) or partial response (PR) without additional systemic therapies. Given age group did not have a significant effect on the model fit, the comparison is made indirectly through the odds ratio across exposure levels in each group. A high response rate may prevent model convergence. Results are shown only upon successful convergence.

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID Tablet	92.9
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID	90.9
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID	86.7

Area Under the Curve (AUClast) Versus Efficacy: Impact of AUClast on Durable Response Rate (DRR) at Day 56 Secondary · Day 56

To assess pharmacokinetic/pharmacodynamic relationship (comparison of AUClast with DRR at day 56). Durable ORR at Day 56 was defined as the percentage of all participants who achieved a complete response (CR) or partial response (PR) at Day 28 and maintained a CR or PR at Day 56. Given age group did not have a significant effect on the model fit, the comparison is made indirectly through the odds ratio across exposure levels in each group. A high response rate may prevent model convergence. Results are shown only upon successful convergence.

Group	Value	95% CI
Group 1: Subjects ≥ 12y to < 18y - RUX 10mg BID	71.4
Group 2: Subjects ≥ 6y to < 12y - RUX 5mg BID	81.8
Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m^2 BID	73.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication, for a maximum duration of 380 days. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 23 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: Subjects >=12y - <18y - RUX 10mg (On-treatment)

Serious: 11/18 (61%)

Deaths: 0/18

Group 2: Subjects >=6y - <12y - RUX 5mg (On-treatment)

Serious: 7/12 (58%)

Deaths: 0/12

Group 3: Subjects >=2y - <6y - RUX 4mg/m2 (On-treatment)

Serious: 6/15 (40%)

Deaths: 0/15

All Subjects

Serious: 24/45 (53%)

Deaths: 0/45

Group 1: Subjects ≥ 12y to < 18y - RUX 10mg (Post-treatment Survival Follow-up)

Serious: 0

Deaths: 6/18

Group 2: Subjects ≥ 6y to < 12y - RUX 5mg (Post-treatment Survival Follow-up)

Serious: 0

Deaths: 2/12

Group 3: Subjects ≥ 2y to < 6y - RUX 4mg/m2 (Post-treatment Survival Follow-up)

Serious: 0

Deaths: 1/15

Group 4: Subjects >= 28 Days to < 2y

Serious: 0

Deaths: 0

Serious adverse events (41 terms)

Reaction	System	Group 1: Subjects >=12y - …	Group 2: Subjects >=6y - <…	Group 3: Subjects >=2y - <…	All Subjects	Group 1: Subjects ≥ 12y to…	Group 2: Subjects ≥ 6y to …	Group 3: Subjects ≥ 2y to …	Group 4: Subjects >= 28 Da…
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—	—	—	—
Viral haemorrhagic cystitis	Infections and infestations	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—
Haemorrhagic disorder	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Immune thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—	—	—	—	—
Gastric haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Intestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Intestinal perforation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Graft versus host disease in gastrointestinal tract	Immune system disorders	—	—	—	—	—	—	—	—
Adenovirus infection	Infections and infestations	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—
Cytomegalovirus viraemia	Infections and infestations	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—
Eye infection viral	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Skin infection	Infections and infestations	—	—	—	—	—	—	—	—

Other adverse events (171 terms — click to expand)

Reaction	System	Group 1: Subjects >=12y - …	Group 2: Subjects >=6y - <…	Group 3: Subjects >=2y - <…	All Subjects	Group 1: Subjects ≥ 12y to…	Group 2: Subjects ≥ 6y to …	Group 3: Subjects ≥ 2y to …	Group 4: Subjects >= 28 Da…
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Cytomegalovirus test positive	Investigations	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Cytomegalovirus infection reactivation	Infections and infestations	—	—	—	—	—	—	—	—
Epstein-Barr virus infection reactivation	Infections and infestations	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—
Cytomegalovirus infection	Infections and infestations	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—	—	—
Weight increased	Investigations	—	—	—	—	—	—	—	—
Central obesity	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Cystitis haemorrhagic	Renal and urinary disorders	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Cushingoid	Endocrine disorders	—	—	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pyrexia, Febrile neutropenia, Sepsis, Septic shock, Viral haemorrhagic cystitis, Acute kidney injury, Haemorrhagic disorder, Immune thrombocytopenia.

Data from ClinicalTrials.gov NCT03491215 adverse events section.

Sponsor's own description

The study was an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages ≥28 days to \<18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. The trial design included four age groups: Group 1 included patients ≥12y to \<18y, Group 2 included patients ≥6y to \<12y, Group 3 included patients ≥2y to \<6y, and Group 4 included patients ≥28days to \<2y.

Publications & conference data

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

Emerging Topical and Systemic JAK Inhibitors in Dermatology.
Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
Prevention and Treatment of Acute Graft-versus-Host Disease in Children, Adolescents, and Young Adults.
Gatza E, Reddy P, Choi SW. · · 2020 · cited 41× · PMID 31931115 · DOI 10.1016/j.bbmt.2020.01.004
Challenges and opportunities targeting mechanisms of epithelial injury and recovery in acute intestinal graft-versus-host disease.
Jansen SA, Nieuwenhuis EES, Hanash AM, Lindemans CA. · · 2022 · cited 24× · PMID 35654837 · DOI 10.1038/s41385-022-00527-6
Ruxolitinib for pediatric patients with treatment-naïve and steroid-refractory acute graft-versus-host disease: the REACH4 study.
Locatelli F, Kang HJ, Bruno B, Gandemer V, et al · · 2024 · cited 10× · PMID 39046767 · DOI 10.1182/blood.2023022565
Ruxolitinib in patients with graft versus host disease (GvHD): findings from a compassionate use program.
Pattipaka T, Sarp S, Nakhaei P, Güneş S. · · 2024 · cited 5× · PMID 38361117 · DOI 10.1038/s41409-024-02207-4
Clinical Development Programme of the Innovative Mesenchymal Stromal Cell Product MSC-FFM/MC0518 for Steroid-Refractory Acute Graft-Versus-Host Disease: Design of 2 Randomised Controlled Trials in Adult and Paediatric Patients.
Zeiser R, Bönig H, Osswald E, Pichlmeier U, et al · · 2026 · PMID 41858687 · DOI 10.1159/000550469
Ruxolitinib Plus Extracorporeal Photopheresis for Steroid-Refractory Acute and Chronic Graft-Versus-Host Disease.
Halahleh K, Sultan I, Abu-Khader A, Al-Far R, et al · · 2025 · PMID 41488726 · DOI 10.14740/jocmr6385
Treatment of steroid-refractory graft versus host disease in children.
Gottardi F, Leardini D, Muratore E, Baccelli F, et al · · 2023 · PMID 38993897 · DOI 10.3389/frtra.2023.1251112

Verify or expand the search:

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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 NCT03491215 (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 Novartis Pharmaceuticals
Last refreshed: 4 May 2025

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/NCT03491215.

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

NCT03491215

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (41 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Ruxolitinib

Other recruiting trials for Acute Graft Versus Host Disease

Other Novartis Pharmaceuticals trials

Verify against primary sources