Seralutinib for Pulmonary Hypertension
(SERANATA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called seralutinib to determine if it can improve exercise ability in people with pulmonary hypertension linked to lung disease. Researchers will compare seralutinib's effects to a placebo (a lookalike treatment with no active drug) over 24 weeks and will monitor long-term safety for up to 144 weeks. The study seeks participants diagnosed with pulmonary hypertension related to lung disease who experience breathing difficulties affecting daily activities, such as walking. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, it mentions that if you are on certain chronic medications for underlying conditions, you must have been on them for at least 16 weeks before the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that seralutinib is likely to be safe for humans?
Research has shown that seralutinib has been tested for safety in both healthy individuals and those with pulmonary arterial hypertension (PAH). In these studies, participants generally tolerated seralutinib well. Most side effects were mild or moderate, such as headaches and a slight increase in heart rate.
Another study observed the long-term use of seralutinib, which continued to demonstrate a good safety record. Serious side effects were rare, with a focus on ensuring that any side effects remained manageable and did not outweigh potential benefits.
Since this trial is in a late phase, seralutinib has already undergone earlier safety testing. This suggests that the treatment is likely safe for most people, though individual reactions can vary. Participants should discuss any concerns with the research team.12345Why do researchers think this study treatment might be promising for pulmonary hypertension?
Researchers are excited about seralutinib for pulmonary hypertension because it offers a novel approach compared to current treatments like endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclin analogs. Most treatments for this condition work by dilating blood vessels or reducing blood pressure, but seralutinib works differently by targeting the PDGFRα/β signaling pathway, which is directly involved in the disease's progression. Additionally, seralutinib is administered via inhalation, which could lead to more direct effects on the lungs and potentially fewer systemic side effects. This unique method of delivery and mechanism of action sets seralutinib apart from existing therapies and drives optimism for improved outcomes in patients.
What evidence suggests that seralutinib might be an effective treatment for pulmonary hypertension?
Research has shown that seralutinib offers promising results for treating pulmonary hypertension, a condition characterized by high blood pressure in the lungs. In earlier studies, seralutinib lowered pressure in the lung blood vessels, allowing patients to be more active without breathlessness. Animal studies demonstrated improved heart and lung function with seralutinib, suggesting potential effectiveness in humans. These findings support seralutinib's potential as an effective treatment for pulmonary hypertension, particularly when combined with other therapies. Participants in this trial will receive either seralutinib at varying dosages or a placebo.13567
Who Is on the Research Team?
Richard Aranda, MD
Principal Investigator
Gossamer Bio Inc.
Are You a Good Fit for This Trial?
Adults aged 18-80 with WHO Group 3 pulmonary hypertension linked to interstitial lung disease can join. They must have a BMI between 15 and 40, specific heart and lung pressure measurements, an FVC of at least 45% predicted, and be able to walk a certain distance. They should be on stable medication for their condition for at least 16 weeks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive seralutinib or placebo for 24 weeks to evaluate exercise capacity improvement
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Extension
Participants receive seralutinib for up to 144 weeks to evaluate long-term safety and tolerability
What Are the Treatments Tested in This Trial?
Interventions
- Seralutinib
Trial Overview
The trial is testing Seralutinib's ability to improve exercise capacity in patients over a period of six months, followed by assessing its long-term safety up to almost three years. Participants will either receive Seralutinib or a placebo through an inhaler.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Seralutinib inhaled orally BID for 24 weeks in PCP. Seralutinib inhaled orally BID up to 144 weeks in LTE.
Seralutinib inhaled orally BID for 24 weeks in PCP. Seralutinib inhaled orally BID up to 144 weeks in LTE.
Placebo inhaled orally twice daily (BID) for 24 weeks in PCP. Subjects randomized to the placebo treatment group in the PCP will receive seralutinib in LTE.
Find a Clinic Near You
Who Is Running the Clinical Trial?
GB002, Inc.
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Industry Sponsor
Citations
Seralutinib for the Treatment of Pulmonary Arterial ...
Conclusions: These OLE data are consistent with TORREY results and support long-term safety and efficacy of inhaled seralutinib in patients ...
Inhaled seralutinib exhibits potent efficacy in models of ...
Inhaled seralutinib was an effective treatment of severe PAH in two animal models, with improved cardiopulmonary haemodynamic parameters, a reduction in NT- ...
Seralutinib in adults with pulmonary arterial hypertension ...
Treatment with inhaled seralutinib significantly decreased PVR, meeting the primary endpoint of the study among patients receiving background ...
Seralutinib Treatment in Adult Subjects With Pulmonary ...
PAH, pulmonary arterial hypertension. Page 4. Seralutinib ... • Objective: To evaluate the efficacy and safety of inhaled seralutinib in PAH over 24 weeks.
Inhaled seralutinib reduces vascular resistance in patients ...
A previous study found that seralutinib lowered pulmonary vascular resistance over 24 weeks. Pulmonary vascular resistance continued to ...
NCT07181382 | Efficacy and Safety of Seralutinib in Adult ...
The primary objective of the LTE is to evaluate the long-term safety and tolerability of seralutinib. Official Title. A Phase 3, Randomized, ...
Seralutinib in adults with pulmonary arterial hypertension ...
In phase 1 studies, seralutinib has been evaluated for safety in healthy volunteers and in patients with PAH.30, 31 In the TORREY study, we aimed to investigate ...
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