SB17170 Phase 2 Trial in IPF Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorSPARK Biopharma
About this trial
This clinical trial is a 2:2:1 randomized, double-blind, placebo-controlled, parallel group, exploratory phase II trial. The main objective of this trial is to compare and evaluate change in FVC compared to placebo by administering SB17170 to moderate to severe patients with IPF. This clinical trial treatment involves administering SB17170 or placebo for 12 weeks.
Eligibility criteria
Qualifiers
Adult male/female 40 years or older at the time of obtaining informed consent
Patients with idiopathic pulmonary fibrosis who are confirmed by chest High-Resolution Computed Tomography (HRCT) scan
Patients with Usual Interstitial Pneumonia (UIP) or probable UIP HRCT pattern consistent with a diagnosis of idiopathic pulmonary fibrosis confirmed through central reading of chest HRCT before the baseline visit
Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria
Disqualifiers
When there is a primary disease showing UIP patterns (rheumatoid arthritis-related interstitial lung disease, connective tissue disease-related interstitial lung disease, etc.) and/or other clinically significant lung abnormalities
Patients with confirmed acute exacerbation of IPF within 6 months prior to screening and/or during the screening period
Patients with lower respiratory tract infections requiring antibiotic treatment
Patients who underwent major surgery within 3 months before screening or have major surgery planned during the clinical trial
Trial design
Treatments tested in this trial
- SB17170
- Placebo
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov