Fostamatinib Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Fostamatinib comprises 24 peer-reviewed publications across 15 journals, 12 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including COVID-19, Arthritis, Rheumatoid, Glomerulonephritis, IGA, and Carcinoma, Non-Small-Cell Lung. Most recent publication: Multiarm multistage randomised controlled trial of inflammatory signal inhibitors (MATIS) for patients hospitalised with COVID-19 pneumonia during the UK pandemic., BMJ Open, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Of mice and men: an open-label pilot study for treatment of immune thrombocytopenic purpura by an inhibitor of Syk.
    Podolanczuk A, Lazarus AH, Crow AR, et al. · Blood · 2009
    PubMed: PMID 19096013 · NCT00706342 · Purpura, Thrombocytopenic, Idiopathic
  2. An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis.
    Weinblatt ME, Kavanaugh A, Genovese MC, et al. · N Engl J Med · 2010
    PubMed: PMID 20879879 · NCT00665925 (Taski-2) · Arthritis, Rheumatoid
  3. OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy.
    Taylor PC, Genovese MC, Greenwood M, et al. · Ann Rheum Dis · 2016
    PubMed: PMID 25074688 · NCT01264770 (OSKIRA -4) · Arthritis, Rheumatoid
  4. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study.
    Tanaka Y, Millson D, Iwata S, et al. · Rheumatology (Oxford) · 2021
    PubMed: PMID 33254235 · NCT01640054 (OSKIRA-Asia-1X) · Arthritis, Rheumatoid
  5. Renin-Angiotensin System Modulation With Synthetic Angiotensin (1-7) and Angiotensin II Type 1 Receptor-Biased Ligand in Adults With COVID-19: Two Randomized Clinical Trials.
    Self WH, Shotwell MS, Gibbs KW, et al. · JAMA · 2023
    PubMed: PMID 37039791 · NCT04924660 (NECTAR) · COVID-19
  6. Translational Biomarkers and Ex Vivo Models of Joint Tissues as a Tool for Drug Development in Rheumatoid Arthritis.
    Kjelgaard-Petersen CF, Platt A, Braddock M, et al. · Arthritis Rheumatol · 2019
    PubMed: PMID 29669391 · NCT01197521 (OSKIRA - 1) · Arthritis, Rheumatoid
  7. Multiarm multistage randomised controlled trial of inflammatory signal inhibitors (MATIS) for patients hospitalised with COVID-19 pneumonia during the UK pandemic.
    Hazell L, Pillay C, Cornelius V, et al. · BMJ Open · 2026
    PubMed: PMID 41644167 · NCT04581954 (MATIS) · COVID-19
  8. Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia: A Randomized Clinical Trial.
    Collins SP, Shotwell MS, Strich JR, et al. · JAMA Netw Open · 2024
    PubMed: PMID 39625722 · NCT04924660 (NECTAR) · COVID-19

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT01197521
OSKIRA - 1
Arthritis, RheumatoidChange From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.
Baseline and 24 weeks
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO1.29 Units on a scale (±13.380 Standard Deviation)
FOSTA 100 MG BID PO0.45 Units on a scale (±2.201 Standard Deviation)
PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO0.13 Units on a scale (±2.142 Standard Deviation)
NCT01197521
OSKIRA - 1
Arthritis, RheumatoidProportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.
24 weeks
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO44.4 Percentage of responders
FOSTA 100 MG BID PO49.0 Percentage of responders
PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO34.2 Percentage of responders
NCT01197534
OSKIRA - 2
Arthritis, RheumatoidProportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo
24 weeks
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO39.6 Percentage of responders
FOSTA 100 MG BID PO39.6 Percentage of responders
PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO24.5 Percentage of responders
NCT01197755
OSKIRA - 3
Arthritis, RheumatoidProportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo
24 weeks
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO27.8 Percentage of responders
FOSTA 100 MG BID PO36.2 Percentage of responders
PLACEBO PO21.1 Percentage of responders
NCT01242514
OSKIRA-X
Arthritis, RheumatoidPercentage of Patients Who Had at Least 1 Adverse Event in Any Category
Entry in extension to end of study (variable duration; maximum 109 weeks)
Fostamatinib 100 mg Bid0.7 Percentage of patients
Fostamatinib 100 mg Bid74.4 Percentage of patients
Fostamatinib 100 mg Bid11.4 Percentage of patients
Fostamatinib 100 mg Bid10.5 Percentage of patients
Fostamatinib 100 mg qd5.7 Percentage of patients
Fostamatinib 100 mg qd9.9 Percentage of patients
Fostamatinib 100 mg qd0.5 Percentage of patients
Fostamatinib 100 mg qd69.8 Percentage of patients
Fostamatinib 150 mg qd8.7 Percentage of patients
Fostamatinib 150 mg qd0.3 Percentage of patients
Fostamatinib 150 mg qd5.9 Percentage of patients
Fostamatinib 150 mg qd70.3 Percentage of patients
NCT02076399
FIT
Purpura, Thrombocytopenic, IdiopathicNumber of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24)
From Week 14 to Week 24
Fostamatinib Recipient9 Participants
Placebo Recipient0 Participants
NCT02076412
FIT
Purpura, Thrombocytopenic, IdiopathicNumber of Participants With Stable Platelet Response of at Least 50,000/µL
Baseline to Week 24
Fostamatinib Recipient9 Participants
Placebo Recipient1 Participants
NCT02077192Purpura, Thrombocytopenic, IdiopathicPercentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Fostamatinib in 047/048 or 049):Version 1
Up to 12 months
Fostamatinib Disodium15.4 Percentage of Subjects
NCT02077192Purpura, Thrombocytopenic, IdiopathicPercentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Placebo in 047/048 and Fostamatinib 049): Version 2
Up to 12 months
Fostamatinib Disodium2.3 Percentage of Subjects
NCT03764618—Durable Hemoglobin Response
24 Weeks
Fostamatinib16 Participants
Placebo12 Participants
NCT04924660
NECTAR
COVID-19Oxygen Free Days Through Day 28.
Day 1 to Day 28
Fostamatinib-1 Days (±NA Standard Deviation)
Fostamatinib14 Days (±NA Standard Deviation)
Fostamatinib13.4 Days (±12.4 Standard Deviation)
Fostamatinib25.5 Days (±3.5 Standard Deviation)
Fostamatinib12.9 Days (±12.5 Standard Deviation)
Fostamatinib21.3 Days (±8.2 Standard Deviation)
Fostamatinib Placebo14.2 Days (±12.1 Standard Deviation)
Fostamatinib Placebo0 Days (±NA Standard Deviation)
Fostamatinib Placebo19.5 Days (±12.5 Standard Deviation)
Fostamatinib Placebo13.9 Days (±12 Standard Deviation)
Fostamatinib Placebo26.5 Days (±0.7 Standard Deviation)
TRV027 (4/20/2022 Arm Closed to Accrual)8.1 Days (±10.8 Standard Deviation)
TRV027 (4/20/2022 Arm Closed to Accrual)8.1 Days (±10.8 Standard Deviation)
TRV027 Placebo10.5 Days (±11.5 Standard Deviation)
TRV027 Placebo10.5 Days (±11.5 Standard Deviation)
TXA127 (4/20/2022 Arm Closed to Accrual)9.0 Days (±10.9 Standard Deviation)
TXA127 (4/20/2022 Arm Closed to Accrual)9.0 Days (±10.9 Standard Deviation)
TXA127 Placebo11.3 Days (±11.5 Standard Deviation)
TXA127 Placebo11.3 Days (±11.5 Standard Deviation)
NCT05593770
NECTAR
COVID-19Oxygen Free Days Through Day 28
Day 1 to Day 28
Fostamatinib13.4 days (±12.4 Standard Deviation)
Placebo14.2 days (±12.1 Standard Deviation)

Publications by year

2001–2026: 24 publications.

2001
1
2002
1
2003
1
2009
1
2010
2
2016
4
2019
2
2021
5
2022
2
2023
2
2024
1
2025
1
2026
1

Publications by indication

COVID-19 (7)

  • Multiarm multistage randomised controlled trial of inflammatory signal inhibitors (MATIS) for patients hospitalised with COVID-19 pneumonia during the UK pandemic.
    BMJ Open · 2026 · PMID 41644167 · NCT04581954
  • Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia: A Randomized Clinical Trial.
    JAMA Netw Open · 2024 · PMID 39625722 · NCT04924660
  • Renin-Angiotensin System Modulation With Synthetic Angiotensin (1-7) and Angiotensin II Type 1 Receptor-Biased Ligand in Adults With COVID-19: Two Randomized Clinical Trials.
    JAMA · 2023 · PMID 37039791 · NCT04924660
  • Fostamatinib for the Treatment of Hospitalized Adults With Coronavirus Disease 2019: A Randomized Trial.
    Clin Infect Dis · 2022 · PMID 34467402 · NCT04579393
  • Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial.
    Trials · 2021 · PMID 33845867 · NCT04581954

Arthritis, Rheumatoid (6)

  • Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study.
    Rheumatology (Oxford) · 2021 · PMID 33254235 · NCT01640054
  • Translational Biomarkers and Ex Vivo Models of Joint Tissues as a Tool for Drug Development in Rheumatoid Arthritis.
    Arthritis Rheumatol · 2019 · PMID 29669391 · NCT01197521
  • OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy.
    Ann Rheum Dis · 2016 · PMID 25074688 · NCT01264770
  • Pharmacokinetic Properties of Fostamatinib in Patients With Renal or Hepatic Impairment: Results From 2 Phase I Clinical Studies.
    Clin Ther · 2016 · PMID 26519231 · NCT01245790
  • Effects of Fostamatinib on the Pharmacokinetics of Digoxin (a P-Glycoprotein Substrate): Results From in Vitro and Phase I Clinical Studies.
    Clin Ther · 2016 · PMID 26514315 · NCT01355354

Glomerulonephritis, IGA (3)

  • Characterisation of an enhanced preclinical model of experimental MPO-ANCA autoimmune vasculitis.
    J Pathol · 2021 · PMID 34124781 · NCT02112838
  • Role of the Spleen Tyrosine Kinase Pathway in Driving Inflammation in IgA Nephropathy.
    Semin Nephrol · 2019 · PMID 30177021 · NCT02112838
  • Emerging therapies in immunoglobulin A nephropathy.
    Nephrology (Carlton) · 2016 · PMID 26032537 · NCT02112838

Carcinoma, Non-Small-Cell Lung (3)

  • Mutations in the SDHB gene are associated with extra-adrenal and/or malignant phaeochromocytomas.
    Cancer Res · 2003 · PMID 14500403 · NCT00923481
  • Biochemical diagnosis of pheochromocytoma: which test is best?
    JAMA · 2002 · PMID 11903030 · NCT00923481
  • 6-[18F]fluorodopamine positron emission tomographic (PET) scanning for diagnostic localization of pheochromocytoma.
    Hypertension · 2001 · PMID 11463751 · NCT00923481

Purpura, Thrombocytopenic, Idiopathic (2)

  • Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib.
    Ther Adv Hematol · 2025 · PMID 33995988 · NCT02076412
  • Of mice and men: an open-label pilot study for treatment of immune thrombocytopenic purpura by an inhibitor of Syk.
    Blood · 2009 · PMID 19096013 · NCT00706342

Lymphoma (1)

  • Inhibition of Syk with fostamatinib disodium has significant clinical activity in non-Hodgkin lymphoma and chronic lymphocytic leukemia.
    Blood · 2010 · PMID 19965662 · NCT00446095

Publications by journal

Trial-results highlights

Clinical trials investigated fostamatinib for rheumatoid arthritis and idiopathic thrombocytopenic purpura.

For rheumatoid arthritis, the OSKIRA-1 study (NCT01197521) evaluated change from baseline to week 24 in modified Total Sharp Score (mTSS). The mean change was 1.29 Units for the fostamatinib 100 mg BID (4 weeks) then 150 mg QD PO arm, 0.45 Units for the fostamatinib 100 mg BID PO arm, and 0.13 Units for the placebo (24 weeks) then fostamatinib 100 mg BID PO arm. In the same study, the proportion of patients with ACR20 at week 24 was 44.4% for the fostamatinib 100 mg BID (4 weeks) then 150 mg QD PO arm, 49.0% for the fostamatinib 100 mg BID PO arm, and 34.2% for the placebo (24 weeks) then fostamatinib 100 mg BID PO arm.

Other studies also assessed ACR20 at week 24. In OSKIRA-2 (NCT01197534), 39.6% of patients in both the fostamatinib 100 mg BID (4 weeks) then 150 mg QD PO arm and the fostamatinib 100 mg BID PO arm achieved ACR20, compared to 24.5% in the placebo (24 weeks) then fostamatinib 100 mg BID PO arm. In OSKIRA-3 (NCT01197755), 27.8% of patients in the fostamatinib 100 mg BID (4 weeks) then 150 mg QD PO arm achieved ACR20, 36.2% in the fostamatinib 100 mg BID PO arm, and 21.1% in the placebo PO arm.

For idiopathic thrombocytopenic purpura (ITP), the FIT study (NCT02076399) reported that 9 participants in the fostamatinib recipient arm had a stable platelet response (count of ≥50,000/µL on at least 4 of the last 6 scheduled visits between weeks 14 and 24), compared to 0 participants in the placebo recipient arm. Another FIT study (NCT02076412) found that 9 participants in the fostamatinib recipient arm achieved a stable platelet response of at least 50,000/µL from baseline to week 24, versus 1 participant in the placebo recipient arm. In a separate study (NCT02077192), 15.4% of subjects in the fostamatinib disodium arm achieved a platelet count of at least 50,000/µL within 12 weeks of beginning treatment up to 12 months.

All values are sourced from primary registry reporting; individual papers should be consulted for clinical decisions.

All Fostamatinib publications (24)

2026 (1 paper)

  1. Multiarm multistage randomised controlled trial of inflammatory signal inhibitors (MATIS) for patients hospitalised with COVID-19 pneumonia during the UK pandemic.
    Hazell L, Pillay C, Cornelius V, et al. · BMJ Open · 2026 · Derived
    PubMed: PMID 41644167 · NCT04581954 (MATIS) · COVID-19

2025 (1 paper)

  1. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib.
    Cooper N, Altomare I, Thomas MR, et al. · Ther Adv Hematol · 2025 · Derived
    PubMed: PMID 33995988 · NCT02076412 (FIT) · Purpura, Thrombocytopenic, Idiopathic

2024 (1 paper)

  1. Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia: A Randomized Clinical Trial.
    Collins SP, Shotwell MS, Strich JR, et al. · JAMA Netw Open · 2024 · Derived
    PubMed: PMID 39625722 · NCT04924660 (NECTAR) · COVID-19

2023 (2 papers)

  1. Renin-Angiotensin System Modulation With Synthetic Angiotensin (1-7) and Angiotensin II Type 1 Receptor-Biased Ligand in Adults With COVID-19: Two Randomized Clinical Trials.
    Self WH, Shotwell MS, Gibbs KW, et al. · JAMA · 2023 · Derived
    PubMed: PMID 37039791 · NCT04924660 (NECTAR) · COVID-19
  2. Syk Inhibition Reprograms Tumor-Associated Macrophages and Overcomes Gemcitabine-Induced Immunosuppression in Pancreatic Ductal Adenocarcinoma.
    Rohila D, Park IH, Pham TV, et al. · Cancer Res · 2023 · Background
    PubMed: PMID 37306759 · NCT06639724 · Pancreatic Neoplasms

2022 (2 papers)

  1. Fostamatinib for the Treatment of Hospitalized Adults With Coronavirus Disease 2019: A Randomized Trial.
    Strich JR, Tian X, Samour M, et al. · Clin Infect Dis · 2022 · Derived
    PubMed: PMID 34467402 · NCT04579393 · COVID-19
  2. Fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia: Phase 2, multicenter, open-label study.
    Kuter DJ, Rogers KA, Boxer MA, et al. · Am J Hematol · 2022 · Derived
    PubMed: PMID 35179251 · NCT02612558 (SOAR)

2021 (5 papers)

  1. Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial.
    Vergis N, Phillips R, Cornelius V, et al. · Trials · 2021 · Derived
    PubMed: PMID 33845867 · NCT04581954 (MATIS) · COVID-19
  2. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study.
    Tanaka Y, Millson D, Iwata S, et al. · Rheumatology (Oxford) · 2021 · Derived
    PubMed: PMID 33254235 · NCT01640054 (OSKIRA-Asia-1X) · Arthritis, Rheumatoid
  3. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic.
    Strich JR, Ramos-Benitez MJ, Randazzo D, et al. · J Infect Dis · 2021 · Derived
    PubMed: PMID 33367731 · NCT04579393 · COVID-19
  4. Characterisation of an enhanced preclinical model of experimental MPO-ANCA autoimmune vasculitis.
    Prendecki M, Gulati K, Turner-Stokes T, et al. · J Pathol · 2021 · Derived
    PubMed: PMID 34124781 · NCT02112838 · Glomerulonephritis, IGA
  5. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
    Kreuzberger N, Hirsch C, Chai KL, et al. · Cochrane Database Syst Rev · 2021 · Derived
    PubMed: PMID 34473343 · NCT04629703 · COVID-19

2019 (2 papers)

  1. Role of the Spleen Tyrosine Kinase Pathway in Driving Inflammation in IgA Nephropathy.
    McAdoo S, Tam FWK · Semin Nephrol · 2019 · Derived
    PubMed: PMID 30177021 · NCT02112838 · Glomerulonephritis, IGA
  2. Translational Biomarkers and Ex Vivo Models of Joint Tissues as a Tool for Drug Development in Rheumatoid Arthritis.
    Kjelgaard-Petersen CF, Platt A, Braddock M, et al. · Arthritis Rheumatol · 2019 · Derived
    PubMed: PMID 29669391 · NCT01197521 (OSKIRA - 1) · Arthritis, Rheumatoid

2016 (4 papers)

  1. Emerging therapies in immunoglobulin A nephropathy.
    Yeo SC, Liew A, Barratt J, et al. · Nephrology (Carlton) · 2016 · Derived
    PubMed: PMID 26032537 · NCT02112838 · Glomerulonephritis, IGA
  2. OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy.
    Taylor PC, Genovese MC, Greenwood M, et al. · Ann Rheum Dis · 2016 · Derived
    PubMed: PMID 25074688 · NCT01264770 (OSKIRA -4) · Arthritis, Rheumatoid
  3. Pharmacokinetic Properties of Fostamatinib in Patients With Renal or Hepatic Impairment: Results From 2 Phase I Clinical Studies.
    Martin P, Oliver S, Gillen M, et al. · Clin Ther · 2016 · Derived
    PubMed: PMID 26519231 · NCT01245790 · Arthritis, Rheumatoid
  4. Effects of Fostamatinib on the Pharmacokinetics of Digoxin (a P-Glycoprotein Substrate): Results From in Vitro and Phase I Clinical Studies.
    Martin P, Gillen M, Millson D, et al. · Clin Ther · 2016 · Derived
    PubMed: PMID 26514315 · NCT01355354 · Arthritis, Rheumatoid

2010 (2 papers)

  1. An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis.
    Weinblatt ME, Kavanaugh A, Genovese MC, et al. · N Engl J Med · 2010 · Derived
    PubMed: PMID 20879879 · NCT00665925 (Taski-2) · Arthritis, Rheumatoid
  2. Inhibition of Syk with fostamatinib disodium has significant clinical activity in non-Hodgkin lymphoma and chronic lymphocytic leukemia.
    Friedberg JW, Sharman J, Sweetenham J, et al. · Blood · 2010 · Derived
    PubMed: PMID 19965662 · NCT00446095 · Lymphoma

2009 (1 paper)

  1. Of mice and men: an open-label pilot study for treatment of immune thrombocytopenic purpura by an inhibitor of Syk.
    Podolanczuk A, Lazarus AH, Crow AR, et al. · Blood · 2009 · Trial result
    PubMed: PMID 19096013 · NCT00706342 · Purpura, Thrombocytopenic, Idiopathic

2003 (1 paper)

  1. Mutations in the SDHB gene are associated with extra-adrenal and/or malignant phaeochromocytomas.
    Gimenez-Roqueplo AP, Favier J, Rustin P, et al. · Cancer Res · 2003 · Background
    PubMed: PMID 14500403 · NCT00923481 · Carcinoma, Non-Small-Cell Lung

2002 (1 paper)

  1. Biochemical diagnosis of pheochromocytoma: which test is best?
    Lenders JW, Pacak K, Walther MM, et al. · JAMA · 2002 · Background
    PubMed: PMID 11903030 · NCT00923481 · Carcinoma, Non-Small-Cell Lung

2001 (1 paper)

  1. 6-[18F]fluorodopamine positron emission tomographic (PET) scanning for diagnostic localization of pheochromocytoma.
    Pacak K, Eisenhofer G, Carrasquillo JA, et al. · Hypertension · 2001 · Background
    PubMed: PMID 11463751 · NCT00923481 · Carcinoma, Non-Small-Cell Lung

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).