sotatercept for PAH

Phase-Based Estimates
2
Effectiveness
3
Safety
Pulmonary Associates, PA ( Site 1008), Phoenix, AZ
sotatercept - Biological
Eligibility
18+
All Sexes
Eligible conditions
PAH

Study Summary

This study is evaluating whether a drug may help improve the symptoms of pulmonary arterial hypertension.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether sotatercept will improve 8 primary outcomes and 7 secondary outcomes in patients with PAH. Measurement will happen over the course of From date of first visit up to 200 weeks.

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

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
sotatercept

This trial requires 700 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sotatercept is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

sotatercept
Biological
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose < 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate 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
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from initiation of treatment visit 1 to the end of study follow-up visit 8 weeks after year 4 for reporting.

Closest Location

Pulmonary Associates, PA ( Site 1008) - Phoenix, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants must have completed their current respective clinical study and its requirements, and must not have discontinued early. show original
See Appendix 4 for information about contraception. show original
Do not donate blood or sperm for 112 days after the last dose of study drug. show original
People who want to participate in the study must be willing to follow the schedule set for them and must be aware of and comply with all the requirements of the protocol. show original
People taking part in the study must be able to understand what they are consenting to, and be able to provide written consent. show original
The subject must have a negative pregnancy test prior to starting the study drug show original
If you are sexually active, have used highly effective contraception without interruption for at least 28 days prior to starting the investigational product, during the study, and for 16 weeks after discontinuing the study drug. show original
Do not breastfeed a child or donate blood, eggs, or ovum for 112 days after the last dose of study drug. show original
Agree to use a condom any time you have sex with a woman who could get pregnant while participating in this study, during dose interruptions, and for at least 16 weeks after stopping the study drug, even if you have had a successful vasectomy. show original
Participants in the A011-12 study must agree not to participate in any other trials of investigational drugs/devices. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get pah a year in the United States?

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More than 50 people die of pah every year in the United States. theme:

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Unverified Answer

How serious can pah be?

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The most common cause of death from Pah is heart disease, but there was no difference in the rates of death from alcohol, intentional injuries, and suicide when comparing Pah deaths with those of the native population of Canada and the United States of America. Pah does not appear to be the most prevalent cause of death and the most prominent health issue among Native people in Canada.\n\nKonopah (Hinuktit-utpi-qalita-tun) is the Nahuatl name for a hallucinogenic drink prepared by mixing maize dough and the juice of the plant "Peucedanum paniculatum".

Unverified Answer

What is the primary cause of pah?

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Most patients (91 %) identified the causes of pah as diabetes, stroke, liver disease, or kidney disease. Other contributing factors included stress and depression (15 % of the patients who reported pah had pah due to anxiety). However many patients who reported pah also reported multiple contributing factors, indicating that stress, anxiety, and pain, may play a role in pah.

Unverified Answer

What are the signs of pah?

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Signs of Pah typically appear over several months and persist for 1–2 years. Pah often presents with recurrent headaches and nausea. Other Pah signs include vomiting, constipation, and a foul smell and taste in the mouth. Pah is thought to be a result of a metabolic condition, but more research is required to confirm this.\n

Unverified Answer

What causes pah?

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Pah may be related to dietary sources of sodium. In individuals exposed to high amounts of sodium in their diet it may result from the increased volume of sodium being excreted in sweat, leading to a sodium deficit through a positive feedback mechanism. Other sodium-containing beverages, including blackened beverages prepared in households and commercial frozen drinks, may also contribute to this problem. Furthermore, individuals having difficulty controlling fluid intake may be especially affected by increased sodium loss through sweat.

Unverified Answer

Can pah be cured?

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Chronic pah is much more challenging to treat than mild-to-severe pah. Inadequate control of the symptoms that accompany pah may necessitate admission to a long-term care facility. Chronic pah usually responds favorably to antidepressants, whereas acute pah often responds to antipsychotic and atypical antipsychotic therapies. The effectiveness of anti-depressants or antidepressive drugs in pah is a matter of intense debate. Severe pah may need prolonged antipsychotic therapy before improvement can be observed.

Unverified Answer

What is pah?

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Pah is a disorder of the liver and the brain that is caused by a lack of methionine. Pah manifests mainly as chronic fatigue, depression and a tendency towards psychosis. Pah is also considered a disease that is similar to cirrhosis and hepatocellular carcinoma.\n

Unverified Answer

What are common treatments for pah?

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Many pah patients report multiple forms of complementary/alternative medicine care to address several issues: pah affects their whole body, their symptoms are persistent or fluctuating, and their treatments may be time-consuming, costly, or complicated. While CAM therapies may help some people to decrease pain and improve general symptoms, there is no evidence they change the course or outcome of symptoms, especially if other treatments have not helped.

Unverified Answer

Is sotatercept safe for people?

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Based primarily on the safety and tolerability data available for people, sotatercept demonstrates a favorable safety profile and should not be withheld from people based on race, sex or age.

Unverified Answer

Who should consider clinical trials for pah?

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Pah may be diagnosed for the first time in adolescence or adulthood. As there aren't any established screening criteria for pah, it's difficult to identify patients that could benefit from clinical trials and treatment. Clinical trials are therefore the best alternative for pah patients. If an individual is considering clinical trials, Power.com can help you join a trial or search for one that fits your current condition (http://www.withpower.com/d/pah-clinics-trials).

Unverified Answer

Does sotatercept improve quality of life for those with pah?

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Treatment with rhPTH led to significant improvements in quality of life for the majority of patients, regardless of age or gender. A significant proportion of patients (10.0%) reported an overall QoL improvement (increased or unchanged) and more than half recorded improvements in several domains. Further efforts are needed to develop and evaluate treatments specifically enhancing physical and social QoL for this high-risk population, particularly among those of male sex, older age, and with a less progressive disease process.

Unverified Answer

What does sotatercept usually treat?

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Sotatercept seems effective for treating pah in children with advanced stage pah and is not effective in children with mild pah. It is effective in adults with advanced pah. It is not reliable to predict the response of sotatercept on the basis of the baseline response. The response should be examined within a randomized controlled trial first, and then monitored by a healthcare team using a standardized protocol.

Unverified Answer
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