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Sotatercept for Pulmonary Arterial Hypertension (MOONBEAM Trial)

Q: Are the enrolment criteria exclusive to individuals above 40 years old?

This clinical trial can accept applicants as young as 1 year old and up to the age of 17. There are 53 trials specifically designed for minors and 658 studies that focus on persons over 65 years old.

Q: What risks are presented to young people aged between one and eighteen by this treatment?

Our research team at Power has assigned a safety score of 2 to minors between the ages 1 and 18. This is mainly due to the fact that this trial is in its second phase, which implies some proof of security but not necessarily efficacy.

Q: Is it still possible to register for participation in this experiment?

Affirmative. Data located on clinicaltrials.gov reveals that this medical trial, which was first posted on January 19th 2023, is currently seeking participants. 42 individuals must be enrolled from a single site for the study to continue forward.

Q: What aims has this research endeavor set out to accomplish?

According to the pharmaceutical firm Merck Sharp &#x26; Dohme LLC, this clinical trial will primarily assess Laboratory Parameter (Hematology): Hematocrit over a 24 week period. Additionally, it will also measure and report on Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohort 1 Only), Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2), as well as Mean Change from Baseline in Eccentricity Index which is defined through Cardiac magnetic imaging (<a href="https://www.withpower.com/clinical-trials/mri">MRI</a>).

Q: To which cohorts is enrollment for this trial open?

42 individuals with pulmonary arterial <a href="https://www.withpower.com/clinical-trials/hypertension">hypertension</a> of varying origin (IPAH, heritable PAH, drug/toxin-induced PAH, etc.) and between 1 year old to 17 years old can participate in this trial. To be eligible for enrollment, participants must adhere to the following conditions: abstain from heterosexual intercourse or use a male condom plus partner using an additional contraceptive method when engaging in penile-vaginal intercourse; female participants should refrain from sexual activities if they are not WOCBP or use highly effective contraception methods; males cannot donate blood or sperm during their involvement in the study as well as 16 weeks after receiving the final

Q: How extensive is the scope of this examination, including the number of participants?

Affirmative, clinicaltrials.gov verifies that this scientific endeavor commenced on January 19th 2023 and is actively recruiting participants. A total of 42 individuals are needed to be enrolled from a single medical centre.

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented, historic diagnostic right heart catheterization (RHC) confirming the diagnosis of PAH WHO Group 1 in specified subtypes

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose day 1, day 21, day 42, day 63, day 84, day105, day 126, day 147, day 168, day 189. postdose day 7, day 14, day 64, day 69 and day 76

Awards & highlights

MOONBEAM Trial Summary

This trial tests the safety and effects of a drug in kids with PAH, and monitors how their bodies process the drug. No outcomes are predicted.

Who is the study for?

This trial is for children aged 1 to under 18 with Pulmonary Arterial Hypertension (PAH) who are already on stable PAH therapy. They must have a confirmed diagnosis and agree to contraception rules if applicable. It's not for those with certain heart or lung conditions, prior severe allergic reactions, or a family history of sudden cardiac death.Check my eligibility

What is being tested?

The study tests the safety, tolerability, and how the body processes Sotatercept over 24 weeks in kids with PAH while they continue their standard treatments. There's no specific hypothesis; it's more about understanding these aspects of the drug in young patients.See study design

What are the potential side effects?

While side effects aren't detailed here, typically such trials look out for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious issues related to heart and lung function due to the nature of PAH treatment.

MOONBEAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a confirmed diagnosis of PAH Group 1 through a right heart catheterization.

MOONBEAM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose day 1, day 21, day 42, day 63, day 84, day105, day 126, day 147, day 168, day 189. postdose day 7, day 14, day 64, day 69 and day 76

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose day 1, day 21, day 42, day 63, day 84, day105, day 126, day 147, day 168, day 189. postdose day 7, day 14, day 64, day 69 and day 76

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose day 1, day 21, day 42, day 63, day 84, day105, day 126, day 147, day 168, day 189. postdose day 7, day 14, day 64, day 69 and day 76 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Curve at Steady State (AUCss) of Sotatercept

Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept

Blood Pressure (BP)

+9 more

Secondary outcome measures

Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2)

Mean Change from Baseline in Eccentricity Index

Nesiritide

+8 more

Side effects data

From 2022 Phase 3 trial • 324 Patients • NCT04576988

20%

Headache

15%

COVID-19

12%

Diarrhoea

12%

Epistaxis

10%

Telangiectasia

10%

Nausea

10%

Fatigue

10%

Dizziness

Injection site pain

Hypokalaemia

Rash

Flushing

Oedema peripheral

Thrombocytopenia

Nasopharyngitis

Urinary tract infection

Dyspnoea

Pulmonary arterial hypertension

Inguinal hernia

Atrial flutter

Iron deficiency

Bronchitis

Fall

Supraventricular tachycardia

Abdominal pain

Pancreatitis

Cellulitis

Pneumonia

Pneumonia influenzal

Respiratory tract infection

Sepsis

Upper respiratory tract infection

Osteoporotic fracture

Acute kidney injury

Haemoptysis

Pulmonary artery aneurysm

Upper gastrointestinal haemorrhage

Joint injury

Sjogren's syndrome

Cerebral haematoma

Device malfunction

Nephritis

Sarcoidosis

Gastroenteritis viral

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Plus Background PAH Therapy (DBPC Period)

Sotatercept Plus Background PAH Therapy (DBPC Period)

Sotatercept Plus Background PAH Therapy (LTDB Period)

Placebo Plus Background PAH Therapy (LTDB Period)

MOONBEAM Trial Design

1Treatment groups

Experimental Treatment

Group I: Children ≥1 to <18 years oldExperimental Treatment1 Intervention

Participants will receive a subcutaneous (SC) injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sotatercept

2019

Completed Phase 3

~680

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,888 Previous Clinical Trials

5,055,041 Total Patients Enrolled

11 Trials studying Pulmonary Arterial Hypertension

1,091 Patients Enrolled for Pulmonary Arterial Hypertension

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,846 Total Patients Enrolled

11 Trials studying Pulmonary Arterial Hypertension

2,312 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Sotatercept (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05587712 — Phase 2

Pulmonary Arterial Hypertension Research Study Groups: Children ≥1 to <18 years old

Pulmonary Arterial Hypertension Clinical Trial 2023: Sotatercept Highlights & Side Effects. Trial Name: NCT05587712 — Phase 2

Sotatercept (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587712 — Phase 2

Frequently Asked Questions

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

Are the enrolment criteria exclusive to individuals above 40 years old?

"This clinical trial can accept applicants as young as 1 year old and up to the age of 17. There are 53 trials specifically designed for minors and 658 studies that focus on persons over 65 years old."

Answered by AI

What risks are presented to young people aged between one and eighteen by this treatment?

"Our research team at Power has assigned a safety score of 2 to minors between the ages 1 and 18. This is mainly due to the fact that this trial is in its second phase, which implies some proof of security but not necessarily efficacy."

Answered by AI

Is it still possible to register for participation in this experiment?

"Affirmative. Data located on clinicaltrials.gov reveals that this medical trial, which was first posted on January 19th 2023, is currently seeking participants. 42 individuals must be enrolled from a single site for the study to continue forward."

Answered by AI

What aims has this research endeavor set out to accomplish?

"According to the pharmaceutical firm Merck Sharp & Dohme LLC, this clinical trial will primarily assess Laboratory Parameter (Hematology): Hematocrit over a 24 week period. Additionally, it will also measure and report on Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohort 1 Only), Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2), as well as Mean Change from Baseline in Eccentricity Index which is defined through Cardiac magnetic imaging (MRI)."

Answered by AI

To which cohorts is enrollment for this trial open?

"42 individuals with pulmonary arterial hypertension of varying origin (IPAH, heritable PAH, drug/toxin-induced PAH, etc.) and between 1 year old to 17 years old can participate in this trial. To be eligible for enrollment, participants must adhere to the following conditions: abstain from heterosexual intercourse or use a male condom plus partner using an additional contraceptive method when engaging in penile-vaginal intercourse; female participants should refrain from sexual activities if they are not WOCBP or use highly effective contraception methods; males cannot donate blood or sperm during their involvement in the study as well as 16 weeks after receiving the final"

Answered by AI

How extensive is the scope of this examination, including the number of participants?

"Affirmative, clinicaltrials.gov verifies that this scientific endeavor commenced on January 19th 2023 and is actively recruiting participants. A total of 42 individuals are needed to be enrolled from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)

2023. "Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05587712.

All > Pulmonary Arterial Hypertension > Pulmonary Hypertension