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SB17170 Phase 2 Trial in IPF Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06747923
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	SPARK Biopharma
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	IPF, Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)

Additional Details

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.

Arms & Interventions

Arms

Experimental: SB17170 of A mg, Single dose

Experimental: SB17170 of B mg, Single dose

Placebo Comparator: Placebo

Interventions

Drug: - SB17170

Taking SB17170 orally once a day

Drug: - Placebo

Taking Placebo orally once a day

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.