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Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396756
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Pliant Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 6, 2020
First Posted Date  ICMJE May 21, 2020
Last Update Posted Date February 1, 2022
Actual Study Start Date  ICMJE March 3, 2020
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
  • Part A - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 28 days ]
  • Part B & C - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
Assessment of PLN-74809 plasma concentrations [ Time Frame: Up to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 15, 2020)
  • Part A - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 28 days ]
  • Part B & C - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 12 weeks ]
  • Part B & C - Change in pulmonary fibrosis score by quantitative HRCT at Week 12 [ Time Frame: Up to 12 weeks ]
  • Assessment of change from baseline in a visual analog scale (VAS) scale for cough [ Time Frame: Up to 12 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE 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)
Brief Summary A Phase 2a, multicenter, 3-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

Three 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 higher PLN-74809 dose cohorts or matching placebo

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: PLN-74809
    PLN-74809
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: PLN-74809 Dose Level 1 (Part A)
    PLN-74809 Dose Level 1 (Part A) - 4 weeks
    Intervention: Drug: PLN-74809
  • Experimental: PLN-74809 Dose Level 2 (Part A)
    PLN-74809 Dose Level 2 (Part A) - 4 weeks
    Intervention: Drug: PLN-74809
  • Experimental: PLN-74809 Dose Level 2 (Part B)
    PLN-74809 Dose Level 2 (Part B) - 12 weeks
    Intervention: Drug: PLN-74809
  • Experimental: PLN-74809 - Dose Level 3 (Part C)
    PLN-74809 Dose Level 3 (Part C) - 12 weeks
    Intervention: Drug: PLN-74809
  • Experimental: PLN-74809 - Dose Level 4 (Part C)
    PLN-74809 Dose Level 4 (Part C) - 12 weeks
    Intervention: Drug: PLN-74809
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2020)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  • FVC %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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pliant Therapeutics Medical Monitor clintrials@pliantrx.com clintrials@pliantrx.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Italy,   Netherlands,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04396756
Other Study ID Numbers  ICMJE PLN-74809-IPF-202
INTEGRIS-IPF ( Other Identifier: Pliant Therapeutics )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Pliant Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pliant Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pliant Therapeutics Medical Monitor Pliant Therapeutics, Inc.
PRS Account Pliant Therapeutics, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP