Study on the efficacy and safety of Pamrevlumab in patients with idiopathic pulmonary fibrosis
Descrizione riassuntiva dello studio
The aim of this study is to investigate the efficacy and safety of Pamrevlumab compared to placebo (a substance that looks like the investigational drug but contains no active ingredient) as monotherapy in patients (Pat.) with idiopathic pulmonary fibrosis (IPF). Pat. who have previously been treated with already approved IPF therapies may participate in the study, provided the Pat. is not currently being treated with an approved IPF therapy. Approximately 340 Pat. will participate in this study. In Switzerland about 3 Pat. As the study investigates how well Pamrevlumab works, the Pat. will be divided into two different groups. The Pat. in one group will receive Pamrevlumab, the investigational drug. The Pat. in the other group will receive a placebo. Form of participation: If you choose to participate, the investigational drug will be administered to you via a needle directly into a vein (this procedure is called infusion). Overall, you will receive 17 infusions over a period of 48 weeks (W). After the visit (V) at W 48, you may choose to participate in the open-label extension. Number and effort of V and corresponding restrictions: If you participate in the study, you will start with a pre-screening phase. This lasts up to 6 W and includes several V. Each V can last between 3 and 5 hours. After the pre-screening phase, you will need to attend 17 V over a period of 48 W. Each V can last between 1 and 4 hours. 4 W after your last treatment with the investigational drug, a safety follow-up will take place and a follow-up phone call will occur at W 9. Various tests will be conducted as part of the study, including: measurement of vital parameters (blood pressure, pulse, and temperature), physical examination, electrocardiogram, blood tests, high-resolution computed tomography (HRCT), questionnaires.
(BASEC)
Intervento studiato
- In the presence of idiopathic pulmonary fibrosis (IPF), the approved therapy for IPF will be administered according to the standard of care.
- The aim of this study is to investigate whether the new treatment (Pamrevlumab) is superior to placebo (a drug without active ingredient).
(BASEC)
Malattie studiate
Idiopathic pulmonary fibrosis (idiopathic pulmonary fibrosis, IPF)
(BASEC)
- Diagnosis of IPF according to guidelines - IPF diagnosis within the last seven years - Interstitial lung fibrosis, defined by HRCT scan (BASEC)
Criteri di esclusione
- Previous treatment with Pamrevlumab. - Evidence of significant obstructive lung disease (narrowing of the airways). - Interstitial lung disease (disease of the interstitial space of the lung IDL) except for IPF. (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. Manuela Funke-Chambour.
+41 31 632 80 99
manuela.funke-chambour@clutterinsel.ch(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
30.05.2022
(BASEC)
ID di studio ICTRP
NCT04419558 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (ICTRP)
Titolo pubblico
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ICTRP)
Malattie studiate
Idiopathic Pulmonary Fibrosis (ICTRP)
Intervento studiato
Drug: Pamrevlumab;Drug: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: 85 Years
Minimum age: 40 Years
Key Inclusion Criteria:
1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory
Society/Japanese Respiratory Society/Latin American Thoracic Association
(ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.
2. High-resolution computed tomography (HRCT) scan at Screening, with =10% to <50%
parenchymal fibrosis (reticulation) and <25% honeycombing.
3. FVCpp value >45% and <95% at Screening and Day 1 (prior to randomization).
4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted =25%
and =90%.
5. Not currently receiving treatment for IPF with an approved therapy for IPF (such as,
pirfenidone or nintedanib) for any reason, including prior intolerance or lack of
response to an approved IPF therapy, or choice to forego treatment with an approved
IPF therapy after a full discussion with the Investigator regarding risks/benefits
of such therapy.
Key Exclusion Criteria:
1. Previous exposure to pamrevlumab.
2. Evidence of significant obstructive lung disease, as evidenced by spirometry or
HRCT.
3. Female participants who are pregnant or nursing.
4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout
the study.
5. Interstitial lung disease other than IPF.
6. Sustained improvement in the severity of IPF during the 12 months prior to
screening.
7. Other types of respiratory diseases that, in the opinion of the Investigator, would
impact the primary protocol endpoint or otherwise preclude participation in the
study, including diseases of the airways, lung parenchyma, pleural space,
mediastinum, diaphragm, or chest wall.
8. Certain medical conditions, that, in the opinion of the Investigator, would impact
the primary protocol endpoint or otherwise preclude participation in the study (such
as, myocardial infarction/stroke, severe chronic heart failure, pulmonary
hypertension, or cancers).
9. Acute IPF exacerbation during Screening or Randomization including hospitalization
due to acute IPF exacerbation within 4 weeks prior to or during screening.
10. Use of any investigational drugs or unapproved therapies, or participation in any
clinical trial with an investigational new drug within 30 days prior to screening.
Or use of approved IPF therapies (such as, pirfenidone or nintedanib) within 1 week
prior to screening.
11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies, or to any component of the excipient. (ICTRP)
non disponibile
Endpoint primari e secondari
DB Period: Change From Baseline in FVC at Week 48 (ICTRP)
DB Period: Time to Disease Progression;DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48;DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First;DB Period: Time to First Acute IPF Exacerbation;DB Period: Time to All-Cause Mortality;DB Period: Time to First Respiratory Hospitalization (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Tracy Ganske;Research Center, tganske@fibrogen.com, (415) 978-1427; (ICTRP)
ID secondari
FGCL-3019-095 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04419558 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile