A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with IPF

• Research type

  Research Study

• Full title

  A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis

• IRAS ID

  1004949

• Contact name

  Farah Ali

• Contact email

  fali@horizontherapeutics.com

• Sponsor organisation

  Horizon Therapeutics Ireland DAC

• Eudract number

  2021-001253-32

• Clinicaltrials.gov Identifier

  NCT05032066

• Research summary

  The purpose of this study is to test if the drug HZN-825 is safe, tolerated, and effective in the treatment of idiopathic pulmonary fibrosis (IPF). The study will compare the effects of HZN-825 with a placebo. HZN-825 and placebo are pills which will be taken by orally and will look the same. Subjects could be placed into one of three treatment groups at random:

  1) 300mg of HZN-825
  2) 600mg of HZN-825
  3) Placebo

  All treatment groups will take 4 pills per day; 2 pills by mouth in the morning and 2 pills in the evening. Subjects will not know which group they are in and neither will the study doctor, but this information can be uncovered in a medical emergency if necessary. Subjects have around a 33.5% chance of receiving placebo and around a 66.5% chance to be on one of the active treatment groups.

  The most common side effects reported from taking HZN-825 are headache, flatulence, abdominal pain, and low blood pressure when standing up which may cause dizziness. Not everyone that takes HZN-825 will experience these, and it could be that there are more side effects not yet known.

  Patients that qualify for the study will be expected to participate for approximately 64 weeks (around 15 months). During this time they will attend 12 study visits at the hospital and have two phone calls. They may also be invited to an open-label study afterwards in which all participants will receive HZN-825 (no placebo).

  They will need to go to the study site for tests which include blood sampling, urine testing, pregnancy testing, lung function testing, tests of heart health, and assessments of general health related to IPF among others. They will also need to undergo 1-2 high-resolution CT scans (HRCT) to image their lungs. They will also be asked to answer some questions about their health at home on a handheld device every evening.

  Approximately 360 subjects between the ages of 18 and 80 years old with IPF will be recruited worldwide.

• REC name

  Wales REC 5

• REC reference

  22/WA/0177

• Date of REC Opinion

  27 Jul 2022

• REC opinion

  Further Information Favourable Opinion