Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)

Pulmonary Arterial Hypertension Clinical 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-

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679570
• Other study ID #: PH-001-SA237
• Secondary ID: jRCT2031210626
• Status: Recruiting
• Phase: Phase 2
• Start date: July 12, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: International University of Health and Welfare
• Contact: Yuichi Tamura
• Phone: +81-3-3451-8121
• Email: tamura.u1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Satralizumab (Genetical Recombination)
Efficacy Evaluation Period: The study drug will be administered at a dose of 120 mg subcutaneously at initial, 2-week, 4-week, and 4-week intervals thereafter. Efficacy will be assessed after 24 weeks of study drug administration. Subjects who demonstrate efficacy and wish to continue treatment will receive the study drug for 24 weeks and moving to the continuous treatment period. In all other cases, the study will be terminated after 24 weeks of the efficacy evaluation period without the administration of study drug. Continuation Dosing Period[1]: Subjects who demonstrate efficacy during the efficacy evaluation period and wish to continue will receive continued 28 weeks (52 weeks total) treatment with satralizumab. Continuation Dosing Period[2]: Subjects completed continuation dosing period[1], clinically capable of continued administration, and wish to continue will receive continued treatment with satralizumab until the end of this study period.

Locations

Country	Name	City	State
Japan	Chiba University Hospital	Chiba
Japan	Kyushu University Hospital	Fukuoka
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kobe University Hospital	Kobe
Japan	Kurume University Hospital	Kurume
Japan	Kyorin University Hospital	Mitaka
Japan	Nagoya University Hospital	Nagoya
Japan	Hokkaido University Hospital	Sapporo
Japan	International University of Health and Welfare Mita Hospital	Tokyo
Japan	Nippon Medical School Hospital	Tokyo

Sponsors (4)

Lead Sponsor	Collaborator
International University of Health and Welfare	Chugai Pharmaceutical, Japan Agency for Medical Research and Development, Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in total pulmonary vascular resistance (PVR) from baseline to 24 weeks.		24 weeks
Secondary	The change in the 6-minute walking distance from baseline to 24 weeks.		24 weeks
Secondary	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).		24 weeks
Secondary	Number of participants with treatment-related adverse events as assessed by MedDRA and changes in general laboratory test values.		52 weeks, beyond 52 weeks(1 year)