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Satralizumab, an Anti-IL-6 receptor antibody, in the treatment of pulmonary arterial hypertension; safety and efficacy evaluation in Japan - Multicenter, Investigator-sponsored Trial- (SATISFY-JP Trial)

SATISFY-JP Trial (SATISFY-JP Trial)

Tamura Yuichi

International University of Health and Welfare Mita Hospital

1-4-3 Mita, Minato-ku Tokyo

tamura.u1@gmail.com

Osawa Yasunori

Keio University Hospital

35 Shinanomachi, Shinjuku-ku Tokyo

+81-3-5315-4278

pm-group@ctr.hosp.keio.ac.jp

Not Recruiting

Feb. 15, 2022

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

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

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.

Both

Pulmonary Arterial Hypertension

The trial will consist of four periods: a screening period (within 30 days), an efficacy evaluation period (24 weeks), a continuous administration period[1] (28 weeks) and a continuous administration period[2].
Screening period
Written consent will be obtained from patients with PAH who have immune responsive-phenotype and inadequate response to existing drugs. After obtaining consent, screening tests related to the study will be conducted to determine eligibility for the study. Baseline testing will be conducted between enrollment and the start of study drug administration.
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.

D006976

D007279

% change in total pulmonary vascular resistance (PVR) from baseline to 24 weeks

1) The change in the 6-minute walking distance from baseline to 24 weeks.
2) Comparison of the % 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).
3) Safety (adverse events, general laboratory tests, blood coagulation system tests, 12-lead ECG, chest X-ray, vital signs, respiratory function tests, arterial blood gas analysis) during the efficacy assessment period. The 52-week safety and byond 52-week (1 year) safty in subjects who were judged as "effective" in the efficacy evaluation period.

+81-476-35-5607

Jan. 07, 2022

No

none