A Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter, Exploratory Phase IIa Clinical Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of SB17170 in Idiopathic Pulmonary Fibrosis (IPF) Patients.
Overview
- Phase
- Phase 2
- Intervention
- SB17170
- Conditions
- IPF
- Sponsor
- SPARK Biopharma
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- Change from baseline in FVC (ml)
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is a progressive respiratory disease characterized by a scarring process of the lung, bringing patients to respiratory failure and death in 3-5 years from diagnosis. Subjects who meet the inclusion/exclusion criteria as a result of the screening test shall be randomized into Test Group 1 (SB17170 A mg), Test Group 2 (SB17170 B mg) and Control Group (Placebo for SB17170) in 2:2:1. Subjects who have been randomized will orally take 2 capsules once daily after a meal according to their assigned administration group for 12 weeks from the date they are prescribed the investigational product. Safety and tolerability at 12 weeks after randomization, and efficacy at 4 \& 12 weeks will be assessed. The subject who has completed 12 weeks of treatment shall visit the trial site after 1 week (Visit 7, EOS) for a follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult male/female 40 years or older at the time of obtaining informed consent
- •Patients diagnosed with idiopathic pulmonary fibrosis who meet the following criteria:
- •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
- •Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at the screening visit
- •Patients meeting pulmonary function test criteria at the screening visit
- •Patients who have received the explanation of this clinical trial and voluntarily agreed and signed the informed consent form
Exclusion Criteria
- •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
- •Patients with a history of malignancy or documented evidence of active or suspected malignancy within 5 years prior to screening
- •Patients with evidence of active infection
- •Patients with the following cardiovascular and cerebrovascular diseases at the time of screening:
- •Severe hypertension within 3 months
- •Myocardial infarction or unstable angina within 6 months
- •History of thrombotic events within 6 months
Arms & Interventions
SB17170 of A mg, Single dose
Intervention: SB17170
SB17170 of B mg, Single dose
Intervention: SB17170
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in FVC (ml)
Time Frame: Week 12
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.
Secondary Outcomes
- Change from baseline in FVC (%)(Week 12)
- Change from baseline in DLCO(Week 12)
- Change from baseline in quality of life and symptoms(Week 12)