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SB17170 Phase 2 Trial in IPF Patients

ConditionsIPFIdiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorSPARK Biopharma

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adult male/female 40 years or older at the time of obtaining informed consent

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SB17170

    Drug

    Taking SB17170 orally once a day

  • Placebo

    Drug

    Taking Placebo orally once a day

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: SB17170 of A mg, Single doseExperimental treatment 1 intervention
Group B: SB17170 of B mg, Single doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Week 12

Secondary outcomes

1

Change from baseline in FVC (%)

Change from baseline in FVC (%) compared to normal predicted values at 12 weeks

Time frame
Week 12
2

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.

Time frame
Week 12
3

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.

Time frame
Week 12
4

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

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SPARK Biopharma

Lead sponsor

Source ClinicalTrials.gov
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