Clinical trial NCT04396756: Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
Official title: A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Pliant Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.

Detailed description: Four part study:

Part A - 4 week treatment period evaluating PLN-74809 or matching placebo

Part B - 12 week treatment period evaluating PLN-74809 or matching placebo

Part C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo

Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo

Eligibility criteria: Inclusion Criteria:

* Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C \& D)
* FVC % of predicted ≥45%
* DLco (hemoglobin-adjusted) ≥30%
* Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed, if on a stable dose for at least 3 months

Exclusion Criteria:

* Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
* Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio \<0.7 at Screening
* Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
* Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
* Smoking of any kind within 3 months of Screening

Primary outcomes:
measure: Part A - Number of Participants With Treatment-Emergent Adverse Events
timeFrame: Up to 4 weeks
measure: Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
timeFrame: Up to 12 weeks
measure: Part D - Number of Participants With Treatment-Emergent Adverse Events
timeFrame: Up to 48 weeks
measure: Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
timeFrame: Up to 4 weeks
measure: Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
timeFrame: Up to 12 weeks
measure: Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Part A - Assessment of PLN-74809 Total Plasma Concentrations
timeFrame: Week 4, 1 Hour Post Dose
measure: Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations
timeFrame: Week 12, 2 Hours Post Dose
measure: Part D - Assessment of PLN-74809 Total Plasma Concentrations
timeFrame: Week 24, 2 Hours Post Dose
Other outcomes:
measure: Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Up to 12 weeks
measure: Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Up to 24 weeks
measure: Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12
timeFrame: Up to 12 weeks
measure: Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24
timeFrame: Up to 24 weeks
measure: Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough
timeFrame: Up to 12 weeks
measure: Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough
timeFrame: Up to 24 weeks
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates, PA
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine
state: California
city: New Haven
country: United States
facility: Yale University Scool of Medicine/ Yale New Haven Hospital
state: Connecticut
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Chesterfield
country: United States
facility: Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield
state: Missouri
city: Greensboro
country: United States
facility: PulmonIx
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Lung Institute at One Hundred Oaks
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Leuven
country: Belgium
facility: UZ Leuven
city: Windsor
country: Canada
facility: Dr. Anil Dhar Medicine Professional Corporation
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Montérégie Centre
state: Quebec
city: Milan
country: Italy
facility: San Giuseppe Hospital, Multimedica S.p.a.
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: EJ
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
state: SZ
city: Greenlane
country: New Zealand
facility: New Zealand Respiratory and Sleep Institute
state: Auckland
city: Christchurch
country: New Zealand
facility: University of Otago Christchurch
Study officials:
affiliation: Pliant Therapeutics, Inc.
name: Pliant Therapeutics Medical Monitor
role: STUDY_DIRECTOR
References: