EudraCT

LEO Pharma presents new Adtralza® (tralokinumab) data following long-term continuous treatment at EADV 30th Congress

Retrieved on: 
Thursday, September 30, 2021
Health, Science, Pharmaceutical, Research, Clinical Trials, Journal of the European Academy of Dermatology and Venereology, Medication, Skin, Patient, EASI, Atopic dermatitis, Congress, DDI, III, Dermatitis, LEO, MD, Development, Adult, Psoriasis Area and Severity Index, DKK, Royal commission, Itch, Disease, Drug, COVID-19, Leo Pharma, Science, TCS, Severe acute respiratory syndrome coronavirus 2, MBA, Research, European Commission, Health care, NOS, Safety, EudraCT, Conditional sentence, NRS, Pharmaceutical industry, Vaccine, Adtralza (tralokinumab), the ECZTEND - Long-Term Extension (LTE), ECZTRA 1 and ECZTRA 2 Trials, atopic dermatitis, LEO Pharma, ADTRALZA (TRALOKINUMAB), THE ECZTEND - LONG-TERM EXTENSION (LTE), ECZTRA 1 AND ECZTRA 2 TRIALS, ATOPIC DERMATITIS, LEO PHARMA

The sustained response over two years further adds to the long-term efficacy profile of Adtralza, said Jrg Mller, Executive Vice President, Global Research and Development, LEO Pharma.

Key Points: 
  • The sustained response over two years further adds to the long-term efficacy profile of Adtralza, said Jrg Mller, Executive Vice President, Global Research and Development, LEO Pharma.
  • A decline in the median EASI percent improvement was observed in the washout cohort within the period without treatment.
  • Following the washout of treatment (>15 weeks), median EASI percent improvement (vs. parent trial baseline) declined to 68.6%.
  • LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries.

MOTIVATE (MOdern Treatment of Inhibitor-positiVe pATiEnts with haemophilia A) Begins Patient Recruitment

Retrieved on: 
Wednesday, June 17, 2020
Health, Haemophilia, Pharmaceutical industry, Clinical trials, Haemophilia A, EudraCT, Patient recruitment, Medical research

MOTIVATE is a multicentre, investigator-initiated study to capture different approaches to the management of patients with haemophilia A and inhibitors.

Key Points: 
  • MOTIVATE is a multicentre, investigator-initiated study to capture different approaches to the management of patients with haemophilia A and inhibitors.
  • MOTIVATE is registered as a non-interventional study in the US ( NCT04023019 ) and as a low-interventional, pragmatic trial in Europe( EudraCT No.
  • Dr Sidonio commented that "It is very exciting that patient recruitment for MOTIVATE has begun.
  • We expect MOTIVATE to provide valuable insights from real-world experience of haemophilia A patients who develop inhibitors to FVIII".

MOTIVATE (MOdern Treatment of Inhibitor-positiVe pATiEnts with haemophilia A) Begins Patient Recruitment

Retrieved on: 
Wednesday, June 17, 2020
Health, Haemophilia, Pharmaceutical industry, Clinical trials, Haemophilia A, EudraCT, Patient recruitment, Medical research

MOTIVATE is a multicentre, investigator-initiated study to capture different approaches to the management of patients with haemophilia A and inhibitors.

Key Points: 
  • MOTIVATE is a multicentre, investigator-initiated study to capture different approaches to the management of patients with haemophilia A and inhibitors.
  • MOTIVATE is registered as a non-interventional study in the US ( NCT04023019 ) and as a low-interventional, pragmatic trial in Europe( EudraCT No.
  • Dr Sidonio commented that "It is very exciting that patient recruitment for MOTIVATE has begun.
  • We expect MOTIVATE to provide valuable insights from real-world experience of haemophilia A patients who develop inhibitors to FVIII".

Arecor announces Phase 1 of AT247 at ADA

Retrieved on: 
Monday, June 15, 2020
Medicine, RTT, Clinical medicine, Organ systems, Diabetes, Artificial pancreas, Biological engineering, Biomedical engineering, Prosthetics, Type 1 diabetes, EudraCT

AT247 also has the potential to enable a fully closed loop artificial pancreas, a potentially life changing treatment option for people living with diabetes."

Key Points: 
  • AT247 also has the potential to enable a fully closed loop artificial pancreas, a potentially life changing treatment option for people living with diabetes."
  • The double-blind, randomised, single dose, three-period cross over Phase I clinical study (EudraCT:2018-003934-34) compared the PK/PD profiles of AT247 to NovoRapidand Fiaspin 19 men with Type I diabetes.
  • Sarah Howell, Chief Executive Officer of Arecor, said:
    "The successful completion of our AT247 Phase I clinical study and selection for an oral presentation at ADA is an important landmark for Arecor.
  • In addition to the potential to improve post prandial blood glucose control, AT247 may play a critical role in advancing artificial pancreas systems.

Arecor Announces Positive Headline Results for the First Phase I Clinical Trial of AT247, a Novel Ultra Rapid Acting Formulation of Insulin

Retrieved on: 
Thursday, December 5, 2019
Eli Lilly and Company, Endocrine system, Hormones, Branches of biology, Peptide hormones, Recombinant proteins, RTT, Diabetes, Insulin, EudraCT, Insulin analog, Intensive insulin therapy

CAMBRIDGE, United Kingdom, Dec. 05, 2019 (GLOBE NEWSWIRE) -- Arecor Limited (Arecor or the Company), the biopharmaceutical company advancing todays therapies to enable healthier lives, today announces positive headline results for the Phase I clinical trial of its ultra-rapid acting insulin product candidate, AT247.

Key Points: 
  • CAMBRIDGE, United Kingdom, Dec. 05, 2019 (GLOBE NEWSWIRE) -- Arecor Limited (Arecor or the Company), the biopharmaceutical company advancing todays therapies to enable healthier lives, today announces positive headline results for the Phase I clinical trial of its ultra-rapid acting insulin product candidate, AT247.
  • AT247, an investigational novel meal-time insulin formulation, aims to significantly accelerate insulin absorption, post injection, to enable more effective management of blood glucose levels.
  • The double-blind, randomised, three-period cross over Phase I clinical study (EudraCT:2018-003934-34) compared the pharmacokinetic and pharmacodynamic profiles of AT247 to NovoRapid and Fiasp.
  • We look forward to reporting the full data from this Phase I study in due course.

TrialAssure Creates Higher Education Discount Pricing Model for Clinical Trial Disclosure Reporting Software

Retrieved on: 
Wednesday, January 30, 2019
Health, Clinical research, Medical research, Articles, Clinical trials registry, Clinical trial, ClinicalTrials.gov, EudraCT, Trial registration

CANTON, Mich., Jan.30, 2019 /PRNewswire/ --TrialAssure a leading, global software company focused on developing clinical trial transparency tools announced today a program called TrialAssure Academic Pricing (TAP) to assist universities globally through managing and disclosing all clinical trial results in a cost-efficient manner.

Key Points: 
  • CANTON, Mich., Jan.30, 2019 /PRNewswire/ --TrialAssure a leading, global software company focused on developing clinical trial transparency tools announced today a program called TrialAssure Academic Pricing (TAP) to assist universities globally through managing and disclosing all clinical trial results in a cost-efficient manner.
  • TrialAssure Registry is a premiere clinical trial registration and disclosure reporting application with a configurable workflow engine that allows clients to augment regulatory intelligence for over 30 registries, including ClinicalTrials.gov and EudraCT, with internal business processes and custom registries.
  • Research shows that only 11 percent of universities post clinical trial results to the European Clinical Trial Register (EUCTR) within required timeframes, according to a report published in The BMJ .
  • TrialAssure helps meet regulatory compliance goals through a flexible, scalable, and streamlined platform that regularly adapts to ever-changing clinical trial disclosure requirements.