SB17170 Phase 2 Trial in IPF Patients

NCT06747923 | Recruiting Phase 2

• 1 other identifier: SMARTT-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

IPF; Idiopathic Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF)

Keywords

HMGB1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Change from baseline in quality of life and symptoms

  Week 12

• Change from baseline in quality of life and symptoms

  Week 12

Study Arms (3)

SB17170 of A mg, Single dose

EXPERIMENTAL

Drug: SB17170

SB17170 of B mg, Single dose

EXPERIMENTAL

Drug: SB17170

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SB17170 DRUG

Taking SB17170 orally once a day

SB17170 of A mg, Single dose; SB17170 of B mg, Single dose

Placebo DRUG

Taking Placebo orally once a day

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SPARK Biopharma: lead

Study Sites (5)

Myong Ji Hospital

Goyang, South Korea

RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

RECRUITING

Seoul Asan Hospital

Seoul, South Korea

NOT YET RECRUITING

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, South Korea

NOT YET RECRUITING

Ajou University Hospital

Suwon, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Seong Yun Bang

CONTACT

+82-2-887-8032; sybang@sparkbio.co.kr

Yu Jin Choi

CONTACT

+82-2-887-9972; yjchoi@sparkbio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 24, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)