NCT06747923

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: SPARK Biopharma · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IPF
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	SB17170	Taking SB17170 orally once a day
DRUG	Placebo	Taking Placebo orally once a day

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-05-30
• Completion: 2026-10-31
• First posted: 2024-12-24
• Last updated: 2025-11-19

Locations

5 sites across 1 country: South Korea