Sotatercept for Pulmonary Arterial Hypertension

(SOTERIA Trial)

Recruiting at 273 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Acceleron Pharma Inc.

Must be taking: PAH therapy

Disqualifiers: Pregnancy, Breastfeeding, Missed doses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 50 months

700 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing sotatercept, a medication for high blood pressure in the lungs, in adults with PAH who have completed earlier studies. It aims to see if the medication is safe and effective over a long period. Sotatercept helps lung blood vessels function better, reducing lung pressure. Sotatercept has shown promising results in earlier studies for reducing lung pressure and improving exercise tolerance in patients with pulmonary arterial hypertension (PAH).

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. It mentions that sotatercept is added to existing PAH therapy, so you may continue your current PAH treatments.

What data supports the effectiveness of the drug Sotatercept for treating Pulmonary Arterial Hypertension?

Research shows that adding sotatercept to existing treatments for pulmonary arterial hypertension (a type of high blood pressure affecting the lungs) improved patients' ability to walk further in 6 minutes after 24 weeks. Additionally, sotatercept significantly reduced the resistance in blood vessels in the lungs, which is a key factor in this condition. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with Pulmonary Arterial Hypertension who've completed previous sotatercept studies without early discontinuation. Participants must agree to contraception and not donate blood or sperm. They can't join if they missed more than 4 doses between studies, have ongoing serious side effects from prior sotatercept trials, or are pregnant/breastfeeding.

Inclusion Criteria

I use and will continue to use effective birth control and a barrier method during the study.

I agree not to breastfeed or donate eggs/blood for 16 weeks after the last study drug dose.

I agree to use specified condoms during the study and for 16 weeks after, even if I've had a vasectomy.

Exclusion Criteria

I am experiencing a serious side effect from a PAH drug study possibly due to sotatercept.

Did not participate in a sotatercept PAH parent trial

Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sotatercept at a dose of 0.3 mg/kg SC initially, escalating to 0.7 mg/kg SC for the remainder of the study

Up to approximately 50 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 48 months

Open-label extension

Participants continue to receive sotatercept to evaluate long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Sotatercept

Trial Overview The study tests the long-term safety and effectiveness of a drug called Sotatercept in patients with PAH when added to their current treatment regimen. It's an open-label follow-up to earlier phases where Sotatercept showed promise in improving heart and lung function.

Participant Groups

Group I: Sotatercept Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Acceleron Pharma Inc.

Lead Sponsor

Trials

27

Recruited

3,100+

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Lead Sponsor

Trials

33

Recruited

4,300+

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Lead Sponsor

Trials

33

Recruited

4,300+

Findings from Research

The Phase 3 STELLAR trial demonstrated that sotatercept significantly improves exercise capacity and reduces pulmonary vascular resistance in patients with pulmonary arterial hypertension, indicating its efficacy as a treatment option.

The study involved a large cohort of patients, providing robust evidence for the safety and effectiveness of sotatercept in managing this serious condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In symptomatic PAH, adding sotatercept to stable background therapy improved 6-min walk distance at 24 wk. Estrada, RA.[2023]

In a phase 3 trial involving 323 adults with pulmonary arterial hypertension, sotatercept significantly improved exercise capacity, as measured by a 34.4 m increase in the 6-minute walk distance compared to just 1.0 m in the placebo group, indicating its efficacy in enhancing physical performance.

Sotatercept also showed significant improvements across multiple secondary endpoints related to pulmonary health, although it was associated with some adverse effects like epistaxis and increased blood pressure, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. Hoeper, MM., Badesch, DB., Ghofrani, HA., et al.[2023]

In a study involving 106 participants with pulmonary arterial hypertension, sotatercept demonstrated significant long-term efficacy in reducing pulmonary vascular resistance and improving functional outcomes over 24 months, with sustained benefits observed in both groups receiving sotatercept.

The treatment was generally safe, with serious adverse events occurring in 30.8% of participants, but only a small number (2.9%) of deaths were reported, none linked to the drug, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. Humbert, M., McLaughlin, V., Gibbs, JSR., et al.[2023]

The phase 3 STELLAR trial indicated that adding sotatercept to background therapy for pulmonary arterial hypertension (PAH) significantly increases life expectancy, with an estimated gain of 11.5 years per patient compared to background therapy alone.

Sotatercept also reduces the need for infused prostacyclin treatments, hospitalizations due to PAH, and the number of lung/heart-lung transplants required, suggesting it may improve overall patient management in PAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH). McLaughlin, V., Alsumali, A., Liu, R., et al.[2023]

In a 24-week trial involving 106 adults with pulmonary arterial hypertension, sotatercept significantly reduced pulmonary vascular resistance compared to placebo, indicating its efficacy in improving this condition.

Sotatercept also improved exercise capacity, as shown by a greater increase in 6-minute walk distance in the treatment groups, although some hematologic adverse events were noted, including thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sotatercept for the Treatment of Pulmonary Arterial Hypertension. Humbert, M., McLaughlin, V., Gibbs, JSR., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

In symptomatic PAH, adding sotatercept to stable background therapy improved 6-min walk distance at 24 wk. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Sotatercept for the Treatment of Pulmonary Arterial Hypertension. [2021]