Trial of Sotatercept in children with pulmonary arterial hypertension

• Research type

  Research Study

• Full title

  A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care

• IRAS ID

  1006644

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Eudract number

  2022-000478-25

• Research summary

  Pulmonary Arterial Hypertension (PAH) is a type of high blood pressure that affects arteries that go from the heart to the lungs. It strains the right side of the heart and causes heart failure affecting quality of life & premature death, despite treatment.
  Globally the incidence & prevalence is low (about 40 per million), however insufficient data is available to confirm the best treatment for children, as their treatment is normally based on data from clinical studies in adults or adult experience.
  This trial is testing the safety and tolerability of Sotatercept (MK-7962), given as an injection, in children and adolescents with PAH. Sotatercept is experimental and has not been approved for sale.
  About 42 male and female participants, aged ≥1 to <18 years of age with PAH, will take part.
  The duration of the trial will be approximately 83 months.
  There is a screening phase, lasting about 28 days, to see if patients can join the trial.
  Eligible participants are allocated 1 of 4 treatment groups;
  •Group 1: 12 to 18yrs, Sotatercept 0.3mg/kg (for 1st 2 visits, rising to 0.7mg/kg after visit 3)
  •Group 2: 6 to 12yrs, Sotatercept 0.3mg/kg
  •Group 3: 2 to 6yrs, Sotatercept 0.3mg/kg
  •Group 4: 1yr to 2yrs, Sotatercept 0.3mg/kg
  The initial treatment period will last 6 months with a site visit every 3 weeks. Then, if the patient tolerates trial treatment, there may be the option of an Optional Extension Phase lasting 6 additional years.
  After the treatment, participants will enter post-treatment follow up& complete a site visit 3 weeks later. The trial team will contact the participant about 2 & 4 months after treatment.
  This trial will be performed at one NHS site in England. The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  London - Brent Research Ethics Committee

• REC reference

  22/LO/0849

• Date of REC Opinion

  20 Jun 2023

• REC opinion

  Further Information Favourable Opinion