Pulmonary Arterial HypertensionPhase 2NCT05679570
Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)
A Phase 2 study testing Satralizumab (Genetical Recombination) in people with Pulmonary Arterial Hypertension, run by International University of Health and Welfare at 9 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Satralizumab (Genetical Recombination)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 9 sitesJapan
- Study dates
- 12 Jul 2022to 14 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose age at the time of consent acquisition is between 20 and 80 years old.
- 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)
- Patients in the World Health Organization (WHO) Functional Classification (FC) I, II, or III.
- Patients with immune responsive-phenotype
- Patients with a 6-minute walking distance of 150 to 600 meters at screening.
- 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
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- 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
- Patients who are receiving home oxygen therapy under the same conditions for at least 30 days prior to enrollment
- Patients who have given written consent for the study
Who cannot join
- Patients with a history of severe allergy to any of the components of the study drug.
- Patients who have received IL-6 inhibitors (tocilizumab, sarilumab, etc.) in the past or are currently receiving them at the time of screening.
- Patients with infectious diseases such as pneumonia or tuberculosis during the screening period.
- Patients with pulmonary artery wedge pressure (PAWP) greater than 15 mmHg on the last right heart catheterization performed during the screening period.
- Patients who are using epoprostenol (intravenous) or treprostinil (intravenous or subcutaneous) and cannot discontinue.
- 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
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- Pregnant women or lactating patients.
- 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
- Patients who have received a live vaccine within 6 weeks prior to enrollment
- Patients who are positive for HIV-1 antibody, HIV-2 antibody, HTLV-1 antibody, HBs antigen, or HCV antibody.
- Patients with active or recurrent bacterial, viral, fungal, or mycobacterial infections, or with other infectious diseases
- 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.
- Patients who are receiving steroids at a dose higher than 10 mg/day of prednisone (PSL) equivalent.
- Patients with a history of malignancy, including solid tumors, hematologic malignancies, and intraepithelial carcinomas, within the past 5 years.
- Patients who are judged to lack the capacity to consent.
- Other patients who are judged by the investigator to be unsuitable for the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Chiba University Hospital
Chiba, 260-8677
Kyushu University Hospital
Fukuoka, 812-8582
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520
Kobe University Hospital
Kobe, 650-0017
Kurume University Hospital
Kurume, 830-0011
Kyorin University Hospital
Mitaka, 181-8611
Nagoya University Hospital
Nagoya, 466-8560
Hokkaido University Hospital
Sapporo, 060-8648
International University of Health and Welfare Mita Hospital
Tokyo, 108-8329
About this study
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-
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Satralizumab (Genetical Recombination)
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satralizumab (Genetical Recombination)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Satralizumab （Genetical Recombination） | Experimental | Not described Receives: Drug: Satralizumab (Genetical Recombination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total pulmonary vascular resistance (PVR) from baseline to 24 weeks.
Measured: 24 weeks
Secondary outcomes (3)
The change in the 6-minute walking distance from baseline to 24 weeks.
Measured: 24 weeks
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).
Measured: 24 weeks
Number of participants with treatment-related adverse events as assessed by MedDRA and changes in general laboratory test values.
Measured: 52 weeks, beyond 52 weeks(1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start12 Jul 2022
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- International University of Health and Welfare
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development, Keio University, Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Yuichi Tamura, Study chair, International University of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679570
- Sponsor's protocol ID
- PH-001-SA237
- Other IDs
- jRCT2031210626
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2022
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-
- ClinicalTrials.gov ID
- NCT05679570
- Acronym / sponsor ID
- PH-001-SA237
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- International University of Health and WelfareUniversity, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development, Keio University, Chugai Pharmaceutical
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Satralizumab （Genetical Recombination） | Experimental | Drug: Satralizumab (Genetical Recombination) |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients whose age at the time of consent acquisition is between 20 and 80 years old.
- 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)
- Patients in the World Health Organization (WHO) Functional Classification (FC) I, II, or III.
- Patients with immune responsive-phenotype
- Patients with a 6-minute walking distance of 150 to 600 meters at screening.
Key exclusion criteria (16 listed)
- Patients with a history of severe allergy to any of the components of the study drug.
- Patients who have received IL-6 inhibitors (tocilizumab, sarilumab, etc.) in the past or are currently receiving them at the time of screening.
- Patients with infectious diseases such as pneumonia or tuberculosis during the screening period.
- Patients with pulmonary artery wedge pressure (PAWP) greater than 15 mmHg on the last right heart catheterization performed during the screening period.
- Patients who are using epoprostenol (intravenous) or treprostinil (intravenous or subcutaneous) and cannot discontinue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Satralizumab （Genetical Recombination） |
Primary outcome
Percent change in total pulmonary vascular resistance (PVR) from baseline to 24 weeks.
Time frame: 24 weeks
3 secondary outcomes
The change in the 6-minute walking distance from baseline to 24 weeks.
Time frame: 24 weeks
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).
Time frame: 24 weeks
Number of participants with treatment-related adverse events as assessed by MedDRA and changes in general laboratory test values.
Time frame: 52 weeks, beyond 52 weeks(1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuichi Tamura study chair
International University of Health and Welfare
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Satralizumab (Genetical Recombination) in people with Pulmonary Arterial Hypertension, run by International University of Health and Welfare at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in total pulmonary vascular resistance (PVR) from baseline to 24 weeks. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.