sotatercept for PAH

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
PAH+5 More
sotatercept - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a drug to see if it's safe and effective for treating Pulmonary Arterial Hypertension.

Eligible Conditions
  • PAH
  • Pulmonary arterial hypertension
  • Pulmonary Arterial Hypertension

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

10 Primary · 7 Secondary · Reporting Duration: From initiation of treatment Visit 1 to the end of study follow-up Visit 8 weeks after year 4

Week 200
Assessment of vital signs - blood pressure (systolic/diastolic)
Assessment of vital signs - body weight
Assessment of vital signs - electrocardiogram (12-lead) for the determination of QTcF interval
Frequency of adverse events (AEs)
Incidence of abnormal clinical chemistry laboratory test results
Incidence of abnormal hematology laboratory test results
Incidence of abnormal urinalysis results
Proportion of study participants with detectable anti-drug antibodies (ADA )
Year 4
Overall Survival (OS)
Year 4
Change in 6-minute walk distance (6MWD)
Change in Borg CR10 Scale (Borg Dyspnea Scale), a measure of exercise tolerance; numerical scale from 0 to 10, with higher number representative of greater exertion.
Change in WHO Functional Class (FC)
Change in serum N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP)
Proportion of participants who maintain or achieve a low risk score using the simplified French Risk score calculator.
Year 4
Pulmonary vascular resistance (PVR) as determined by right heart catheterization
Up to 200 weeks
Number of participants with adverse events (AEs)
Number of participants with detectable anti-drug antibodies (ADAs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

sotatercept
1 of 2
Sotatercept Treatment
1 of 2

Experimental Treatment

700 Total Participants · 2 Treatment Groups

Primary Treatment: sotatercept · No Placebo Group · Phase 3

sotatercept
Biological
Experimental Group · 1 Intervention: sotatercept · Intervention Types: Biological
Sotatercept Treatment
Biological
Experimental Group · 1 Intervention: Sotatercept · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotatercept
2019
Completed Phase 2
~370

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from initiation of treatment visit 1 to the end of study follow-up visit 8 weeks after year 4

Who is running the clinical trial?

Acceleron Pharma Inc.Lead Sponsor
26 Previous Clinical Trials
2,640 Total Patients Enrolled
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Lead Sponsor
32 Previous Clinical Trials
3,801 Total Patients Enrolled
Jonathan Lu, MD, PhDStudy DirectorAcceleron Pharma Inc.
1 Previous Clinical Trials
150 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,619 Previous Clinical Trials
7,936,172 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to understand and provide documented informed consent.
You must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.