IPFPhase 2NCT06747923
SB17170 Phase 2 Trial in IPF Patients
A Phase 2 study testing SB17170 in people with IPF and Idiopathic Pulmonary Fibrosis, run by SPARK Biopharma at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- IPF, Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- SB17170
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 27 Jan 2025to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Myong Ji Hospital
Goyang
Wonil Choi, M.D.
- Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Jin Young Huh
- Not yet recruiting
Seoul Asan Hospital
Seoul
Jin Woo Song, M.D.
- Not yet recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul
Yong Suk Jo, M.D.
- Not yet recruiting
Ajou University Hospital
Suwon
Joo Hun Park, M.D.
About this study
Official title: 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.
Read the 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.
- Being tested
- SB17170, Placebo
- Keywords
- HMGB1
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB17170Drug
Taking SB17170 orally once a day
PlaceboDrug
Taking Placebo orally once a day
| Study group | Role | What they receive |
|---|---|---|
| SB17170 of A mg, Single dose | Experimental | Not described Receives: Drug: SB17170 |
| SB17170 of B mg, Single dose | Experimental | Not described Receives: Drug: SB17170 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in FVC (ml)
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.
Measured: Week 12
Secondary outcomes (5)
Change from baseline in FVC (%)
Change from baseline in FVC (%) compared to normal predicted values at 12 weeks
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start27 Jan 2025
- Primary completion30 May 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPARK Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747923
- Sponsor's protocol ID
- SMARTT-004
- Status last verified
- Nov 2025
- First submitted
- 17 Dec 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06747923
- Acronym / sponsor ID
- SMARTT-004
- Keywords
- HMGB1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SPARK BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SB17170 of A mg, Single dose | Experimental | Drug: SB17170 |
| SB17170 of B mg, Single dose | Experimental | Drug: SB17170 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB17170Taking SB17170 orally once a day | Drug | SB17170 of A mg, Single dose, SB17170 of B mg, Single dose |
| PlaceboTaking Placebo orally once a day | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Change from baseline in FVC (%)
Time frame: Week 12
Change from baseline in DLCO
Time frame: Week 12
Change from baseline in quality of life and symptoms
Time frame: Week 12
Change from baseline in quality of life and symptoms
Time frame: Week 12
Change from baseline in quality of life and symptoms
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB17170 in people with IPF and Idiopathic Pulmonary Fibrosis, run by SPARK Biopharma at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seong Yun Bang (+82-2-887-8032, sybang@sparkbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in FVC (ml) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.