A Phase 2 Study of Sotatercept for Cpc-PH Treatment

• Research type

  Research Study

• Full title

  Phase 2, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

• IRAS ID

  1004197

• Contact name

  SaraBeth Hahn

• Contact email

  shahn@xlrn.com

• Sponsor organisation

  Acceleron Pharma Inc.

• Eudract number

  2021-003020-32

• Clinicaltrials.gov Identifier

  NCT04945460

• Research summary

  This study is for patients diagnosed with a form of Pulmonary hypertension (PH) associated with left heart disease known as heart failure (HF) with preserved ejection fraction (HFpEF), who fall into either Class II or Class III of the New York Heart Association (NYHA) categories.
  PH is a disease affecting the blood vessels of the lungs. PH leads to increased pressure in blood vessels of the lungs which further leads to straining of the right side of the heart.
  Sotatercept is a new medicine that is believed to decrease the wall thickness of blood vessels in the lung. This allows more blood into the lung blood vessels and therefore may help improve shortness of breath and increase exercise capacity.
  Participants will be randomly assigned in a 1:1:1 ratio to one of 3 treatment arms after screening period for up to 24 weeks of a double blind, placebo-controlled treatment period.
  • Arm 1: Placebo administered subcutaneously (SC - injection) every 3 weeks for 24 weeks
  • Arm 2: Sotatercept SC at dose of 0.3 mg/kg for 24 weeks
  • Arm 3: Sotatercept SC at starting dose of 0.3 mg/kg for 3 dosing visits, then up to 0.7mg/kg SC on fourth dosing visit, administered SC every 3 weeks for remainder of 24-week treatment period
  Participation is for up to 27 months includes a 28-day screening period, 24 week double-blind, placebo-controlled treatment period, 18-month extension period and 8-week follow-up period. Study visits to site are every 3 weeks.
  120 participants will be recruited globally, randomly assigned to one of treatment groups (40 per group).
  Study procedures such as Right Heart Catheterisation (RHC), Electrocardiogram (ECG), Echocardiogram (ECHO), physical examinations, blood and urine tests to mention a few will also be done.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  21/LO/0908

• Date of REC Opinion

  25 Jan 2022

• REC opinion

  Further Information Favourable Opinion