Clinical trial NCT05679570: Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)
Official title: Satralizumab,an Anti-IL-6 Receptor Antibody, in the Treatment of Pulmonary Arterial Hypertension; Safety and Efficacy Evaluation in Japan -Multicenter, Investigator-sponsored Trial-
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: International University of Health and Welfare
Sponsor class: OTHER
Collaborators: name: Japan Agency for Medical Research and Development
name: Keio University
name: Chugai Pharmaceutical
First posted: 2023-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Examine the efficacy of satralizumab in patients with pulmonary arterial hypertension (PAH) with immune-responsive phenotype serum interleukin-6 (IL-6) ≥ 2.73 pg/mL who have an inadequate response to existing drugs.


Eligibility criteria: Inclusion Criteria:

1. Patients whose age at the time of consent acquisition is between 20 and 80 years old.
2. Patients who have been diagnosed with pulmonary arterial hypertension (PAH) and fall into one of the following among the first group of the clinical classification of pulmonary hypertension (Nice Classification, 2018) Idiopathic pulmonary arterial hypertension (IPAH) Hereditary pulmonary arterial hypertension (HPAH) Drug/toxin-induced pulmonary arterial hypertension Pulmonary arterial hypertension associated with connective tissue disease Pulmonary arterial hypertension associated with congenital heart disease (only after repair surgery)
3. Patients in the World Health Organization (WHO) Functional Classification (FC) I, II, or III.
4. Patients with immune responsive-phenotype
5. Patients with a 6-minute walking distance of 150 to 600 meters at screening.
6. Patients whose resting hemodynamic values within 30 days prior to enrollment meet all of the following Mean pulmonary artery pressure (mPAP) is 25 mmHg or higher PVR is higher than 4 Wood units
7. Patients who are using up to three PAH drugs and have not changed the dosage and administration for at least 90 days prior to enrollment
8. Patients who are receiving home oxygen therapy under the same conditions for at least 30 days prior to enrollment
9. Patients who have given written consent for the study

Exclusion Criteria:

1. Patients with a history of severe allergy to any of the components of the study drug.
2. Patients who have received IL-6 inhibitors (tocilizumab, sarilumab, etc.) in the past or are currently receiving them at the time of screening.
3. Patients with infectious diseases such as pneumonia or tuberculosis during the screening period.
4. Patients with pulmonary artery wedge pressure (PAWP) greater than 15 mmHg on the last right heart catheterization performed during the screening period.
5. Patients who are using epoprostenol (intravenous) or treprostinil (intravenous or subcutaneous) and cannot discontinue.
6. Patients who are currently participating in other clinical trials or clinical studies. Or, patients who have participated in other clinical trials/trials prior to participation in this study and whose adverse events, if any, have occurred during the period of participation and have not been confirmed to have resolved or stabilized
7. Pregnant women or lactating patients.
8. Patients who are unable to consent to contraception from the time of obtaining consent until at least 3 months after the last dose of the study drug
9. Patients who have received a live vaccine within 6 weeks prior to enrollment
10. Patients who are positive for HIV-1 antibody, HIV-2 antibody, HTLV-1 antibody, HBs antigen, or HCV antibody.
11. Patients with active or recurrent bacterial, viral, fungal, or mycobacterial infections, or with other infectious diseases
12. Patients who have been hospitalized or developed an infection requiring intravenous administration of an infectious agent within 4 weeks prior to the baseline visit or an infection requiring oral administration of an infectious agent within 2 weeks prior to the baseline visit.
13. Patients who are receiving steroids at a dose higher than 10 mg/day of prednisone (PSL) equivalent.
14. Patients with a history of malignancy, including solid tumors, hematologic malignancies, and intraepithelial carcinomas, within the past 5 years.
15. Patients who are judged to lack the capacity to consent.
16. Other patients who are judged by the investigator to be unsuitable for the study.

Primary outcomes:
measure: Percent change in total pulmonary vascular resistance (PVR) from baseline to 24 weeks.
timeFrame: 24 weeks
Secondary outcomes:
measure: The change in the 6-minute walking distance from baseline to 24 weeks.
timeFrame: 24 weeks
measure: Comparison of the percent change in PVR from baseline to 24 weeks between the satralizumab group in this study and an external control group (selected from patients enrolled in JAPHR).
timeFrame: 24 weeks
measure: Number of participants with treatment-related adverse events as assessed by MedDRA and changes in general laboratory test values.
timeFrame: 52 weeks, beyond 52 weeks(1 year)
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Tokyo
country: Japan
facility: International University of Health and Welfare Mita Hospital
Study officials:
affiliation: International University of Health and Welfare
name: Yuichi Tamura
role: STUDY_CHAIR
References: