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)

Who can take part?

You may be able to take part if you have a form of interstitial lung disease (ILD), including idiopathic pulmonary fibrosis (IPF) or systemic sclerosis‑associated ILD (SSc‑ILD). These conditions cause scarring of the lungs, making it harder to breathe.

You may be eligible if you:

• Have been diagnosed with IPF or systemic sclerosis‑associated ILD
• Meet certain lung function requirements based on breathing tests
• Are able to complete a walking test

Additional criteria may apply depending on the study group you are assigned to.

You would not be able to take part if:

• You have an unstable or undiagnosed health condition
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether vixarelimab, an investigational antibody treatment, may help reduce inflammation and lung scarring.

Participants will be randomly assigned to receive the study medication.

• Study duration: Approximately 60 weeks
• Clinic visits: Every 2 weeks during treatment (some visits may be completed at home)

The study includes:

• A screening period (up to 40 days)
• A treatment period (52 weeks)
• A follow‑up period (7 weeks)

Participants who complete the treatment period may be eligible for a longer-term extension study.

What will I need to do?

If you take part, you will be asked to:

• Receive the study medication as a subcutaneous injection every 2 weeks
• Attend regular clinic or home visits
• Take part in assessments, which may include:
• • Breathing tests
  • A walking test (6‑minute walk test)
  • Blood tests
  • A heart tracing (ECG)
  • Questionnaires about your health

If you have systemic sclerosis‑associated ILD, additional tests such as skin ultrasound or biopsy may be included.

You will also have regular contact with the study team throughout the study.

More information

You can read more about this study here:

• ClinicalTrials.gov – Vixarelimab Study