Sofapi

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2025-10-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

MSD

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Our first objective is to assess whether [68Ga]Ga-FAPI PET/CT imaging can non-invasively assess pulmonary artery remodeling in PAH patients.

Secondary objectives 10

1. Pulmonary artery remodeling, as assessed with [68Ga]Ga-FAPI PET/CT imaging, decreases in PAH patients after 24 weeks treatment with Sotatercept
2. Regional lung perfusion, as assessed with [68Ga]Ga-MAA lung perfusion PET/CT imaging, is improved after 24 weeks of Sotatercept treatment in PAH patients
3. Right ventricle (RV) uptake on FAPI PET/CT imaging is associated with RV dysfunction in PAH patients
4. Right ventricle (RV) activity, as assessed with [68Ga]Ga-FAPI PET/CT imaging, decreases after 24 weeks of Sotatercept treatment in PAH patients
5. Vascular remodeling on [68Ga]Ga-FAPI PET/CT is correlated with hemodynamic parameters on RHC in PAH patients
6. Vascular remodeling on [68Ga]Ga-FAPI PET/CT is correlated with 6 minutes walking test result (6MWT) in PAH patients
7. Vascular remodeling on [68Ga]Ga-FAPI PET/CT is correlated with NYHA functional class in PAH patients
8. Vascular remodeling on [68Ga]Ga-FAPI PET/CT is correlated with quality of life (Emphasis 10) measure in PAH patients
9. Description of imaging parameters
10. Description of imaging parameters

Conditions and MedDRA coding

Pulmonary arterial hypertension (PAH)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 18 years old or more
2. Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum PVR of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes: o Idiopathic PAH o Heritable PAH o Drug/toxine-induced PAH o PAH associated with connective tissue disease o PAH associated with simple, congenital systemic-to- pulmonary shunts at least 1year following repair
3. Patients under bi or tri-background-therapy
4. Symptomatic PAH classified WHO FC II or III
5. Patients will be started on Sotatercept
6. Ability to adhere to study visit schedule and understand and comply with all the protocol requirement.
7. Ability to understand and provide written informed consent

Exclusion criteria 6

1. Diagnosis of PH WHO Groups 2, 3, 4, or 5
2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
3. Hemoglobin at screening above gender-specific ULN, per local laboratory test
4. Pregnant or breastfeeding women
5. Any of the following clinical laboratory values at the Screening Visit: - eGFR < 30 mL/min/1.73 m2 (as defined by MDRD equation) - Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels > 3 × ULN
6. A known allergy has been identified with sotatercept (ACE-011), its excipients, or luspatercept.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. [68Ga] Ga-FAPI uptake (Yes/No) of pulmonary arteries on PET/CT imaging in patients with PAH at V0. The uptake will be assessed visually and outcome considered as success by consensus of two nuclear medicine physicians, using the surrounding vascular background as a reference.

Secondary endpoints 10

1. [68Ga] Ga-FAPI uptake on pulmonary arteries at V1 and V2(after 24 weeks treatment with Sotatercept). This will be assessed using a visual scale and the Standardized uptake value (SUVmax).
2. Regional lung perfusion will be assessed by quantifying the Pulmonary vascular obstruction index (PVOI) on [68Ga]Ga-MAA lung perfusion PET/CT at V1 and V2 (after 24 weeks treatment with Sotatercept)
3. [68Ga] Ga-FAPI uptake on the RV (SUVmax) and a RV ventricule dysfunction based on Tricuspid annular plane systolic excursion (TAPSE)<17mm.
4. [68Ga] Ga-FAPI uptake on the RV (SUVmax) at V1 and V2
5. [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with hemodynamic parameters on RHC (PAPm, CO, RAP, RVP, PVR)
6. [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with 6 minutes walking test result (6MWT) in PAH patients
7. [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with NYHA functional class in PAH patients
8. [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with Nt-proBNP measure in PAH patients
9. [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with quality of life (Emphasis 10) measure in PAH patients
10. Qualitative and quantitative evaluation of imaging parameters, including image quality and reproducibility, acquisition time, radiation dose, ease of interpretation, technical success rate, inter-operator variability, and the impact of acquisition parameters on biomarker quantification.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Et Universitaire De Brest

Sponsor organisation

Centre Hospitalier Regional Et Universitaire De Brest

Address

2 Avenue Marechal Foch

City

Brest

Postcode

29200

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Cécile Tromeur

Public contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Fouad abdelillah

Sponsor responsibilities

Article 77 compliance

Centre Hospitalier Regional Et Universitaire De Brest

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications