SB17170 Phase 2 Trial in IPF Patients

November 17, 2025 updated by: SPARK Biopharma

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in FVC (%)
Time Frame: Week 12
Change from baseline in FVC (%) compared to normal predicted values at 12 weeks
Week 12
Change from baseline in DLCO
Time Frame: Week 12
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
Time Frame: Week 12

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
Time Frame: Week 12

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
Time Frame: Week 12

UCSD Shortness of Breath Questionnaire

: Scores range from 0 to 120, with higher numbers indicating greater shortness of breath.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SPARK Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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