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.

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF); IPF
• Intervention / Treatment: Drug: SB17170; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Seong Yun Bang; Phone Number: +82-2-887-8032; Email: sybang@sparkbio.co.kr
• Study Contact Backup: Name: Yu Jin Choi; Phone Number: +82-2-887-9972; Email: yjchoi@sparkbio.co.kr

Study Locations

• South Korea
  • Goyang, South Korea
    • Recruiting
    • Myong Ji Hospital
    • Contact: Wonil Choi, M.D.
  • Gwangmyeong, South Korea
    • Recruiting
    • Chung-Ang University Gwangmyeong Hospital
    • Contact: Jin Young Huh
  • Seoul, South Korea
    • Not yet recruiting
    • Seoul Asan Hospital
    • Contact: Jin Woo Song, M.D.
  • Seoul, South Korea
    • Not yet recruiting
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital
    • Contact: Yong Suk Jo, M.D.
  • Suwon, South Korea
    • Not yet recruiting
    • Ajou University Hospital
    • Contact: Joo Hun Park, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult male/female 40 years or older at the time of obtaining informed consent

2. 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
3. Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria
4. Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at the screening visit
5. Patients meeting pulmonary function test criteria at the screening visit
6. Patients who have received the explanation of this clinical trial and voluntarily agreed and signed the informed consent form

Exclusion Criteria:

1. 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
2. Patients with confirmed acute exacerbation of IPF within 6 months prior to screening and/or during the screening period
3. Patients with lower respiratory tract infections requiring antibiotic treatment
4. Patients who underwent major surgery within 3 months before screening or have major surgery planned during the clinical trial
5. Patients with a history of malignancy or documented evidence of active or suspected malignancy within 5 years prior to screening
6. Patients with evidence of active infection

7. 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
8. Patients with pulmonary hypertension
9. 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
10. Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Taking Placebo orally once a day
Experimental: SB17170 of A mg, Single dose	Drug: SB17170; Taking SB17170 orally once a day
Experimental: SB17170 of B mg, Single dose	Drug: SB17170; Taking SB17170 orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in FVC (ml)	Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in FVC (%)	Change from baseline in FVC (%) compared to normal predicted values at 12 weeks	Week 12
Change from baseline in DLCO	DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.	Week 12
Change from baseline in quality of life and symptoms	Living with Pulmonary Fibrosis (L-PF) questionnaire : Scores range from 0 to 100, with higher numbers indicating a greater impairment.	Week 12
Change from baseline in quality of life and symptoms	EuroQoL Five-Dimensional Instrument(EQ-5D) : Scores range from -0.594 to 1.0, with higher numbers indicating a better health	Week 12
Change from baseline in quality of life and symptoms	UCSD Shortness of Breath Questionnaire : Scores range from 0 to 120, with higher numbers indicating greater shortness of breath.	Week 12

Collaborators and Investigators

• Sponsor: SPARK Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: HMGB1
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: SMARTT-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No