SB17170 Phase 2 Trial in IPF Patients

Last updated: February 9, 2025
Sponsor: SPARK Biopharma
Overall Status: Active - Recruiting

Phase

2

Condition

Idiopathic Pulmonary Fibrosis

Cystic Fibrosis

Pulmonary Fibrosis

Treatment

Placebo

SB17170

Clinical Study ID

NCT06747923
SMARTT-004
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 followingcriteria:

  • Patients with idiopathic pulmonary fibrosis who are confirmed by chestHigh-Resolution Computed Tomography (HRCT) scan

  • Patients with Usual Interstitial Pneumonia (UIP) or probable UIP HRCT patternconsistent with a diagnosis of idiopathic pulmonary fibrosis confirmed throughcentral reading of chest HRCT before the baseline visit

  1. Patients with a history of idiopathic pulmonary fibrosis treatment who meet thedefined criteria

  2. Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at thescreening visit

  3. Patients meeting pulmonary function test criteria at the screening visit

  4. Patients who have received the explanation of this clinical trial and voluntarilyagreed and signed the informed consent form

Exclusion

Exclusion Criteria:

  1. When there is a primary disease showing UIP patterns (rheumatoid arthritis-relatedinterstitial lung disease, connective tissue disease-related interstitial lungdisease, etc.) and/or other clinically significant lung abnormalities

  2. Patients with confirmed acute exacerbation of IPF within 6 months prior to screeningand/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 majorsurgery planned during the clinical trial

  5. Patients with a history of malignancy or documented evidence of active or suspectedmalignancy within 5 years prior to screening

  6. Patients with evidence of active infection

  7. Patients with the following cardiovascular and cerebrovascular diseases at the timeof 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

  1. Patients with pulmonary hypertension

  2. Patients who are unable to take drugs orally or have a history of majorgastrointestinal surgery or pathological findings that may affect the absorption ofthe investigational product

  3. Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B orC

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 27, 2025
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Myong Ji Hospital

    Goyang,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong,
    Korea, Republic of

    Active - Recruiting

  • Seoul Asan Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

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