Mosliciguat for Pulmonary Hypertension
(PHocus Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Pulmovant, Inc.
Must not be taking: Mosliciguat, sGC stimulators
Disqualifiers: PH Group 1, 2, 4, 5, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on investigational or experimental therapy, you must stop it at least 42 days before joining the trial.
What data supports the effectiveness of the drug Mosliciguat (BAY 1237592) for treating pulmonary hypertension?
How is the drug Mosliciguat different from other treatments for pulmonary hypertension?
Research Team
SP
Sudhir Penugonda, MD
Principal Investigator
Pulmovant, Inc.
Eligibility Criteria
This trial is for people with a condition where high blood pressure in the lungs is caused by scarring or inflammation of lung tissue (PH-ILD). Participants should have this specific type of lung and heart issue but not be dealing with other major health problems that could interfere with the study.Inclusion Criteria
Participants willing and able to provide informed consent
I can walk 100 meters or more without stopping.
I have a lung condition diagnosed by a CT scan with less than 70% normal lung function.
See 1 more
Exclusion Criteria
I have had a bad reaction or no improvement with mosliciguat or similar medications.
My lung condition hasn't worsened in the last 28 days.
I need more than 10 liters per minute of oxygen at rest.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive inhaled mosliciguat or placebo daily for 24 weeks in a double-blind, placebo-controlled period
24 weeks
Extension
All participants who complete the 24-week double-blind period may continue to receive mosliciguat in the extension period
Beyond 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Mosliciguat (Stimulator of Soluble Guanylate Cyclase)
Trial OverviewThe study tests mosliciguat, a new treatment delivered through an inhaler, against a placebo (a substance with no active drug) to see if it's safe and effective for PH-ILD. People will be randomly assigned to either get mosliciguat or the placebo without knowing which one they receive.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ExtensionExperimental Treatment2 Interventions
After Week 24, all participants may receive mosliciguat through an Extension period
Group II: MosliciguatActive Control2 Interventions
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Group III: Matched PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pulmovant, Inc.
Lead Sponsor
Trials
1
Recruited
120+
Findings from Research
Riociguat (Adempas) is an innovative medication specifically designed to treat pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), conditions that cause high blood pressure in the lungs.
Clinical studies have demonstrated that riociguat effectively improves exercise capacity and overall functional status in patients with these types of pulmonary hypertension, making it a valuable treatment option.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Riociguat (adempas): a novel agent for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.Khaybullina, D., Patel, A., Zerilli, T.[2020]
Riociguat, a first-in-class drug that activates soluble guanylate cyclase, has been shown to significantly improve exercise capacity in patients with pulmonary hypertension, as evidenced by the CHEST-1 and PATENT-1 phase-3 clinical trials involving 16 weeks of therapy.
The drug demonstrated a modest safety profile, with hypotension being the most common adverse effect, and has received regulatory approval for treating pulmonary arterial hypertension and inoperable chronic thromboembolic pulmonary hypertension, offering new hope for patients with this serious condition.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Riociguat: Something new in pulmonary hypertension therapeutics?Shanmugam, E., Jena, A., George, M.[2020]
In a study of 71 patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) treated with riociguat for 3 to 12 months, significant reductions in right atrial and right ventricular size were observed after 12 months, indicating improved heart function.
Long-term riociguat treatment also led to an increase in right ventricular function measures, such as TAPSE and fractional area change, suggesting that riociguat is effective in improving right heart function in patients with PAH and CTEPH.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Right ventricular size and function under riociguat in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (the RIVER study).Marra, AM., Halank, M., Benjamin, N., et al.[2020]
References
Riociguat (adempas): a novel agent for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. [2020]
Riociguat for Sarcoidosis-Associated Pulmonary Hypertension: Results of a 1-Year Double-Blind, Placebo-Controlled Trial. [2023]
Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. [2020]
Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. [2022]
Riociguat: Something new in pulmonary hypertension therapeutics? [2020]
Right ventricular size and function under riociguat in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (the RIVER study). [2020]
Riociguat, a soluble guanylate cyclase stimulator, ameliorates right ventricular contraction in pulmonary arterial hypertension. [2020]
Change of right heart size and function by long-term therapy with riociguat in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. [2017]