RecruitingPhase 2NCT06747923

SB17170 Phase 2 Trial in IPF Patients

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.

Sponsor

SPARK Biopharma

Enrollment

30 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)IPF

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria8

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 Criteria14

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
Diagnosis of heart failure within 6 months
Patients with pulmonary hypertension
Patients who are unable to take drugs orally or have a history of major gastrointestinal surgery or pathological findings that may affect the absorption of the investigational product
Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C