A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis05/23/2019 - 03/31/2023 (PI)
Corbus Pharmaceuticals Holdings, Inc.
Scleroderma Cyclophosphmide or Transplantation (SCOT) Study08/01/2011 - 10/31/2022 (Subcontract PI)
Duke University NIH NIAID
Translational studies for identifying and targeting novel pathways in systemic sclerosis pathogenesis09/22/2017 - 08/31/2022 (Subcontract PI)
University of Pittsburgh NIH NIAMS5P50AR060780-07
Protocol #201247, A multi-centre, randomized, double-blind (sponsor open), placebo-controlled, repeat dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics pharmacodyna08/30/2017 - 08/29/2022 (PI)
GlaxoSmithKline LLC
A Phase 1 Open-Label Study to Determine the Safety and Tolerability of AVID200, a Transforming Growth Factor B (TGFB) Inhibitor, in Patients with Diffuse Cutaneous Systemic02/25/2019 - 02/24/2022 (PI)
Formation Biologics Corp.
Protocol # ITN075AI, (BRAVOS) - Evaluation of Brentuximab Vedotin in Diffuse Cutaneous Systemic Sclerosis02/01/2017 - 01/31/2022 (Co-Investigator of Sub-Project / SP)
Benaroya Research Institute at Virginia Mason NIH NIAID2UM1AI109565-08
OPsumit Historical USers cohort study (OrPHeUS). a Multicenter. retrospective chart review of first-time Opsumit® (macitentan) users in the United States02/06/2018 - 12/31/2021 (PI)
Actelion Pharmaceuticals, Ltd.
United States Pulmonary Hypertension Scientific Registry10/11/2016 - 12/31/2021 (PI)
United States Pulmonary Hypertension Scientific Registry
US-based, observation, drug registry of Opsumit (macitentan) new users in clinical practice01/16/2015 - 12/08/2021 (PI)
Actelion Pharmaceuticals, Ltd.
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis12/01/2015 - 11/30/2021 (PI)
Corbus Pharmaceuticals Holdings, Inc.
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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Tocilizumab versus Placebo in Patients with Systemic Sclerosis04/05/2016 - 04/30/2020 (PI)
Genentech, Inc.
Dimethyl Fumarate In Systemic Sclerosis-Associated Pulmonary Arterial Hypertension01/01/2018 - 03/31/2020 (Subcontract PI)
University of Pittsburgh NIH NIAMS5R21AR069285-03
Protocol #LTI-301 - A Phase 3 Open-Label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients02/21/2018 - 02/20/2020 (PI)
Liquidia Technologies, Inc.
A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with 'Systemic Sclerosis associated Interstitial Lung08/22/2016 - 08/21/2019 (PI)
Boehringer Ingelheim Pharmaceuticals, Inc.
ASSET: A Phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis - a double-blind, placebo-controlled, randomized controlled trial [IMI101-344]03/31/2015 - 06/30/2019 (Co-Investigator)
Regents of the University of Michigan Bristol-Myers Squibb
Autologous Adipose-Derived Regenerative Cells12/09/2015 - 06/01/2019 (PI)
Cytori Therapeutics, Inc.
A Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitia08/05/2016 - 04/30/2019 (PI)
EMD Serono Research & Development Institute, Inc.
Rituximab for Treatment of SSc-PAH (ASC01)05/01/2016 - 04/30/2019 (Subcontract PI)
The Regents of the University of California, San Francisco NIH NIAID5UM1AI110498-05
Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study04/18/2017 - 04/17/2019 (PI)
Sanofi-Aventis, U.S., LLC
A Phase II Multi-Center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation with Post Transplant Maintenance for the Treatment of01/06/2016 - 01/05/2019 (Subcontract PI)
Fred Hutchinson Cancer Research Center Scleroderma Res Fdn
An open-label, randomized, phase 2 study of the safety and tolerability of pirfenidone when administered09/01/2013 - 08/31/2018 (PI)
InterMune, Inc.
National Biological Sample and Data Repository for PAH03/01/2016 - 02/28/2018 (Subcontract PI)
Children's Hospital Medical Center NIH NHLBI4R24HL105333-05
Long-term Follow-Up of Participants in the Scleroderma: Cyclophosphamide or Transplantation (SCOT) Trial05/01/2017 - 10/15/2017 (Subcontract PI)
Duke University NIH NIAID
NIAMS: CORT09/01/2011 - 08/31/2017 (PI)
NIH/National Institute of Arthritis & Musculoskeletal & Skin Diseases5P50AR060780-05
Rheumatic Diseases Research Core Centers09/01/2011 - 08/31/2017 (PI)
NIH/National Institute of Arthritis & Musculoskeletal & Skin Diseases5P30AR061271-05
Environmental Mycobiome Modifiers of Inflammation and Fibrosis in Systemic Sclerosis08/20/2014 - 08/19/2017 (Subcontract PI)
Trustees of Dartmouth College dba Dartmouth College DOD Army Med Resrch
A Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis-A Phase I/II Biomarker and Safety Trial04/02/2015 - 04/01/2017 (Co-Investigator)
PI:
Robert A. Lafyatis, MDPRISM Pharma Co Ltd
A Phase-2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effecacy of Pomalidomide06/01/2012 - 06/30/2016 (PI)
Celgene Corporation
The Natural History and Outcome of Scleroderma Patients at High Risk or With Early Pulmonary Hypertension (PHAROS)07/01/2008 - 12/31/2015 (PI)
Gilead Sciences, Inc.
A Two Stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial02/01/2009 - 02/28/2014 (PI)
Actelion Pharmaceuticals, Ltd.
An Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic Sclerosis (Distol-P02/01/2009 - 02/28/2014 (PI)
United Therapeutics Corporation
Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers asso03/01/2012 - 02/28/2013 (PI)
Actelion Clinical Operations, Inc.
Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers asso03/01/2012 - 02/28/2013 (PI)
Actelion Clinical Operations, Inc.
Two Stage Genome-Wide Association Study01/15/2010 - 01/14/2013 (PI)
University of Texas
DISTOL-EXT: Digital Ischemic Lesions in Scleroderma Treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study10/01/2009 - 12/31/2012 (PI)
United Therapeutics Corporation
A Phase 1, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Single and Multiple Intravenous Doses of MEDI-546, a Fully Human Monoclonal Antibody Directed Against Subunit 108/01/2009 - 12/31/2012 (PI)
MedImmune, Inc.
Digital Ischemic Lesions in Scleroderma Treated with Oral Treprostinil Diethanolamine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study05/01/2009 - 12/31/2012 (PI)
United Therapeutics Corporation
Scleroderma Cyclophosphamide or Transplantation (SCOT) Study03/03/2005 - 05/12/2012 (Subcontract PI)
Duke University NIH NIAID
Rheumatology Fellowship Training Award07/01/2008 - 06/30/2009 (PI)
American College of Rheumatology Research and Education Foundation
A Study of the Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon01/08/2008 - 08/15/2008 (PI)
MediQuest Therapeutics, Inc.
PHAROS03/01/2006 - 06/30/2008 (PI)
Georgetown University Scleroderma Fdn
Rheumatology Fellowship Award07/01/2004 - 06/30/2008 (PI)
Amgen, Inc.
Phase III, In-life Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Prevention of Raynaud’s Phenomenon01/01/2007 - 06/30/2007 (PI)
MediQuest Therapeutics, Inc.
Long Term Open-Label Study in Patients with Interstitial Lung Disease Associated with Systemic Sclerosis who Completed the Protocol AC-052-330 / BUILD 203/14/2005 - 03/13/2007 (PI)
Actelion Clinical Operations, Inc.
Phase III “In-Life” Study of a Topical Gel Formulation of Nitroglycerin , MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon12/15/2005 - 05/15/2006 (PI)
MediQuest Therapeutics, Inc.
A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy on Infliximab in Subjects with Giant Cell Arteritis11/01/2003 - 11/01/2005 (Co-PI)
Centocor, Inc.
Scleroderma Lung Study08/10/1999 - 06/30/2005 (Co-PI)
PI:
Arthur C. Theodore, MDNIH/National Heart, Lung, and Blood Institute5 U01 HL60682 05
A Multi-Center, Blinded, Randomized, Placebo-controlled, Sequential Crossover Study of OPC-212/01/2001 - 09/30/2002 (PI)
Otsuka America Pharmaceutical Inc
An Open Label Study of the Safety of Subcutaneous Continuous Infusion of Recombinant Human Relaxin for 52 Weeks in Subjects with Systemic Sclerosis04/25/2000 - 04/30/2001 (PI)
Connetics Corporation