GB44496 – Genentech (Idiopathic Pulmonary Fibrosis, Scleroderma cohort)

A Two-cohort, Phase 2, multicentre, randomised, double-blind, parallel-group, placebo-controlled study evaluating the efficacy and safety of Vixarelimab compared to placebo in patients with Idiopathic Pulmonary Fibrosis and patients with Systemic Sclerosis-Associated Interstitial Lung Disease

MOONSCAPE (GB44496)

Study Population

Approximately 200 participants are planned to be randomized into Cohort 1 (IPF), and 60-120 participants into Cohort 2 (SSc-ILD).

Idiopathic pulmonary fibrosis (IPF) is a condition in which the lungs become scarred and breathing becomes increasingly difficult. Systemic sclerosis is a chronic autoimmune disease that causes the skin and internal organs, such as the lungs, to thicken and harden. Systemic sclerosis-associated interstitial lung disease (SSc-ILD) is a progression of SSc, where the lungs become scarred and breathing becomes difficult. Both these conditions are part of a group of diseases called fibrotic interstitial lung diseases (ILDs).

Vixarelimab is an antibody (a type of protein in the immune system that acts to stop things like infection from harming the body). It works by attaching to and blocking a protein that is present on the surface of different types of cells in the body, including in the lungs. Antibodies that block this particular protein can potentially prevent it from triggering inflammation and fibrosis.

This study will assess the efficacy and safety of vixarelimab for the treatment of IPF/SSc-ILD, and also aims to better understand the studied disease and associated health problems.

Eligible participants:

Cohort 1 (IPF):

• male or female, between 40 and 85 years of age, with diagnosis of IPF evidenced on CT scan.
• Lung function with FVC above 45% predicted.
• 6 Minute Walk Test over 150 metres

Cohort 2 (SSc-ILD) :

• male or female, between 18 and 85 years of age, with diagnosis of Systemic Scerosis
• CT Scan showing >10% fibrosis
• Progression of pulmonary disease, evidenced by respiratory symptoms, lung function and/or CT scan
• Lung function with FVC above 45% predicted.

Subjects with an undiagnosed or unstable disease will not be eligible to participate in the study until stable.

Study Visits

• The treatment period comprises of an onsite clinic visit or at home visit (for some visits) every 2 weeks over 52 weeks.
• The planned study duration for each participant is approximately 60 weeks, comprising the Screening Period (up to 1-40 days), the Treatment Period (52 weeks), and the Follow-up Period (7 weeks). Participants who complete the 52 week Treatment period may be eligible to enter the Optional Open-Label Extension Study for a further 52 weeks.

Study Requirements

• Sub-cutaneous injection every 2 weeks throughout the treatment period.
• Lung function test, 6 Minute Walk Test, blood tests, ECG at selected onsite visits.
• Skin ultrasound and biopsy at selected visits for Cohort 2 participants.
• Completion of questionnaires on electronic device
  

Clinical Trials Registry:

https://clinicaltrials.gov/study/NCT05785624