Research Studies - IIR/ECR

Research Studies - IIR/ECR

There are a number of Investigator-Initiated Research (IIR) and External Collaborative Research (ECR) studies related to Mallinckrodt products in varying stages of completion. Click on the links provided below to learn more.

To access our online submission portal please click here: IIR/ECR Portal


Investigator-Initiated Research (IIR) Studies

Acthar® Gel

ACTH as a Re-Emerging Therapy for Uveitis (The ACTHAR Study)

ACTH for Cutaneous Sarcoidosis Open Label Study

Acthar® Gel Stimulation of Neurosteroid Synthesis 

Acthar in Rheumatoid Arthritis, Histologic and Functional Effect on Synovium

Acthar in the Treatment of Lupus Nephritis

Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients

An Open Label, Multi-centered, Randomized Phase 2 Study to Evaluate the Safety, TolerabiLity and Bioactivity of Subcutaneous ACTH Gel in Patients with Scleritis: The ATLAS Study

A single-site, investigator-initiated, open-label trial of H.P. Acthar Gel in subjects with moderately to severely active ankylosing spondylitis (AS) 

Biomarkers to Characterize Subtypes of Neuroinflammation in Infantile Spasms and Responsiveness to ACTH

BRIGHT-MS Study: Utility of ADC Maps in Patients with Acute Demyelinating Lesions

Clinical Impact of Acthar in the Psoriatic Arthritis Patient

Comparative Safety and Efficacy of ACTHar gel alone or in combination with oral Tacrolimus to reducing proteinuria in patients with idiopathic Fibrillary Glomerulopathy 

Effect of ACTH in Interactions Between Antigen Presenting Cells and CD4 Tcells- Relapsing Remitting MS

Efficacy and Safety of Acthar for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis

Ocular Sarcoidosis: Open Label Trial of Acthar Gel

Open Label Proof of Concept Study to Evaluate Efficacy and Safety of ACTH Gel in Refractory DM/PM

Open Label Study to Evaluate Efficacy and Safety of Short-term Adjunctive Adrenocorticotropic Hormone (ACTH) Gel Therapy in Rheumatoid Arthritis

Outcomes of Patients with Infantile Spasms Treated with ACTHAR Gel

Phase 4 Trial of Neuroprotection with ACTH in Acute Optic Neuritis

Use of ACTH in RA Related Flares

Use of Acthar in CKD Stage V or ESRD Patients in Preparation for a Kidney Transplant

Use of CXCL9 as a Biomarker of Acthar Efficacy



A Single-Center, Randomaised, Controlled Trail of the Efficacy and Safety of the Investigations drug “Inhaled Nitric Oxide (INOflo)” for the Patients with Severe Right Heart Failure Due to Pulmonary Hypertension

A Prospective, Multicenter Registry for Premature Newborns with Severe Pulmonary Hypertension

Effect of Nitric Oxide on Key Hox Transcription Factor Proteins During ELBW O2-Induced Lung Injury

Effects of Inhaled Nitric Oxide on Cerebral Blood Flow in Healthy Adults and Ischemic Stroke Patients

Efficacy of Nitric Oxide administration, during Cardiopulmonary Bypass in Neonates, in reducing the risk of Acute Kidney Injury: a pilot double-blind randomized controlled trial 

The impact of fluctuating arterial oxygen saturation on cerebral autoregulation in preterm infants with late onset hypoxemic respiratory failure 

Improvement in Acute Respiratory Parameters in Preterm Infants Under 34 Weeks Gestation after Initiation of INO in the Setting of Hypoxemic Respiratory Failure

Inhaled Nitric Oxide after Out-Of-Hospital Cardiac Arrest

Inhaled Nitric Oxide and Hypoxic Brain Injury in the Newborn

Inhaled Nitric Oxide Gas Therapy, in Mechanically Ventilated Patients with, Severe Acute Respiratory Syndrome in COVID-19 

Inhaled NO In Hyperoxia-Mediated Decreased Alveolarization In RHAMM Knockout Mice

INO following Traumatic Brain Injury 

Neuroprotective effects of inhaled nitric oxide in a newborn rat pup model of hypoxic-ischemic encephalopathy

Nitric Oxide (NO) - A potent anticoagulant for cardio pulmonary bypass (CPB) and Extracorporeal Membrane Oxygenator (ECMO) Therapy

Nitric Oxide Responsivity in Infants with Severe Chronic Lung Disease 

Nitric Oxide In Right Ventricular Dysfunction: Improvements In Clinical And Hemodynamic Parameters On VA ECMO (NOVICE) 

Prevention Of Transfusion Related Gut Injury (TRAGI) In ELGAN Neonates Using INO Proof Of Concept Pilot: The NO-TRAGI Trial 

Alternatives to heparin on ECMO

Treatment of delayed pulmonary transition in extremely preterm infants & bronchopulmonary dysplasia 

Utilization of inhaled nitric oxide therapy in preterm infants in Canadian neonatal intensive care units



Differences in Outcomes Between Teaching and Non-teaching Hospitals in Patients with HRS

Hemodynamic profile of Terlipressin and Octreotide in patients with cirrhosis and portal hypertension (HVPG ≥ 12mmHg)

The impact of continuous Terlipressin infusion on sarcopenia and ascites in end-stage liver disease

The impact of continuous Terlipressin infusion on cirrhotic cardiomyopathy in end-stage liver disease

The Impact of Acute-on-Chronic Liver Failure on Survival in Patients with Decompensated Cirrhosis

Terlipressin bolus vs continuous infusion in patients with Variceal hemorrhage


Therakos® – U.S.

Randomized phase II study of ECP in combination with corticosteroids for the initial treatment of aGvHD (Main Study) 

Tumor-specific immunity after extracorporeal photopheresis in patients with Sézary syndrome at single-cell resolution 

UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX® Photopheresis System as an interventional therapy for the treatment of CTCL (Mycosis Fungoides) in patients with TMN classification stage IA, IB or IIA

Therakos® – EU

A multi- center randomized phase II study comparing corticosteroids alone versus corticosteroids and Extracorporeal Photophoresis (ECP) as first-line treatment of standard risk Grade II acute graft-versus-host disease after allogenic stem cell transplantation

ECP in high-risk chronic graft-versus-host disease

Large Single Center Retrospective Analysis of Efficacy of Extracorporeal Photopheresis in Treatment of Chronic Graft versus Host Disease

Multicenter analysis of efficacy and outcomes of extracorporeal photopheresis as treatment of chronic lung allograft dysfunction

Observational for ECP in acute or chronic GvHD after allogeneic hematopoietic stem cell transplantation for hematological malignancies

Phase II multicenter study of extracorporeal photopheresis plus standard steroid treatment for high risk acute graft-versus-host disease 

Prophylactic Use of Extracorporeal Photopheresis (ECP) after Lung Transplantation 

The Siena ECP Registry and Software - Research protocol for extracorporeal photopheresis in lung transplant patients


External Collaborative Research (ECR) Studies


Interactions between Macrophages and Engineered Tissues

Pre-Clinical Assessment of StrataGraft™ for Deep Partial and Full Thickness Burns in Normal and SCID Pigs

Scarring in Stratagraft-treated vs. autograft-treated burn wounds: a clinical and histological investigation 



A Multi-Center, Open Label, External Collaborative Research- ECR Study to treat HRS-AKI patients with Continuous Terlipressin Infusion 



Impact of photopheresis in the prevention of acute rejection in highly sensitized de novo kidney transplant recipients

Improved outcome of chimeric antigen receptor (CAR) T cell therapy supported by extracorporeal photopheresis treatment - the effect of methoxypsoralen and UV-A light versus steroids on CAR T cell function

Phase 1/2 Trial to determine the safety and efficacy of Extracorporeal photopheresis as treatment for steroid-refractory immune related adverse events after immune checkpoint inhibitor therapy

Retrospective data analysis of patients with systemic sclerosis and extracorporal photopheresis versus standard of care therapy