A study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis.
Scientific Title of Study
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)
Trial Acronym
BEACON-IPF
Secondary IDs if Any
Secondary ID
Identifier
NCT06097260
ClinicalTrials.gov
PLN-74809-IPF-206 (Version 2.2) dated 30 April 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Australia Argentina Belgium Brazil Canada Chile China Czech Republic Denmark France Germany Greece India Israel Italy Japan Netherlands New Zealand Poland Portugal Republic of Korea Spain Taiwan Turkey United Kingdom United States of America
"Institutional Ethics Committee, KLE University KLE University KLE Dr.PK Hospital and MRC Nehru Nagar Belagavi Belagavi Belagavi (Belgaum) Karnataka - 590010 India"
Submittted/Under Review
B.P. Poddar And Parvati Devi Foundation For Education, 71/1, Humayun Kabir Sarani New Alipore, Block-G, Kolkata-700053, West Bengal, India
Approved
Bhatia Hospital Medical Research Society Ethics Committee, Tardeo Road, Mumbai – 400007, Maharashtra India
Approved
Ethics Committee of SDS TRC and RGICD
Approved
IEC for Midland and Research Centre, Midland Healthcare and Research Center, B-55 and C-42 Mandir Marg, Mahanagar Extension, Lucknow -226006, Uttar Pradesh, India.
Approved
Institutional Ethics Committee for ESIC Faridabad ESIC Medical College and Hospital, NH-3 NIT Behind BK Hospital, Faridabad-121001, Haryana, India.
Approved
Institutional Ethics Committee, Jawahar Lal Nehru Medical College Kala Bagh, Ajmer– 305001, Rajasthan, India
Approved
Institutional Ethics Committee, Kansos Super Speciality Hospital
Approved
Institutional Ethics Committee, The Calcutta Medical Research Institute 7/2, Diamond Harbour Road, Kolkata - 700027 ,West Bengal, India
Approved
Lakeview Ethics Committee, Lakeview Heart And Super Speciality Hospital CTS No 5653/17-20,Mahatma Phule Road, Near Goaves, Shastri Nagar Belagavi—590010, Karnataka India
Approved
Max Healthcare Ethics Committee, Ground Floor, Office Of Ethic Committee West Block, Near MS Office, Max Super Speciality Hospital, Saket (A Unit Of Max Healthcare Institute Limited), 1, Press Enclave Road, Saket, New Delhi-110017, India
Unity Hospital Ethics Committee, Unity Trauma Center and ICU, N-4 Janki Park Society, Aai Mata Road, Paravat Patiya, Surat-395010, Gujarat, India.
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Bexotegrast
PLN-74809 (bexotegrast) 160 mg tablets will be taken orally once daily at approximately 24-hour intervals. Treatment duration is 52 weeks.
Comparator Agent
Placebo
Matching placebo will be taken orally once daily at approximately 24-hour intervals. Treatment duration is 52 weeks.
Inclusion Criteria
Age From
40.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Greater than or equal to 40 years of age prior to screening
2.IPF diagnosis less than or equal to 7 years prior to screening
3.FVCpp greater than or equal to 45 percentage
4.Diffusing capacity for carbon monoxide percent predicted hemoglobin-adjusted greater than or equal to 30 percentage and less than 90 percentage
5.Current treatment for IPF with background therapy is allowed, if at a stable dose for greater than or equal to 12 weeks prior to screening
6.If not currently receiving treatment for IPF either treatment naïve or discontinued prior treatment, participant must not have taken background therapy for within 8 weeks prior to screening
ExclusionCriteria
Details
1.Receiving pharmacologic therapy for pulmonary hypertension
2.Self-reported smoking of any kind not limited to tobacco less than or equal to 12 weeks prior to the screening or unwilling to avoid smoking throughout the study
3.History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
4.Hepatic impairment or end-stage liver disease
5.Renal impairment or end stage kidney disease requiring dialysis
6.Pregnant or lactating female participant
7.Uncontrolled systemic arterial hypertension
8.Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
9.Prior administration of bexotegrast
10. Likely to have lung transplantation during the study being on transplantation list is not an exclusion
11.Forced expiratory volume in the first second/FVC ratio less than 0.7 at Screening
12. Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
13. Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To characterize the effect of bexotegrast versus placebo on the change in forced vital capacity (FVC) in participants with idiopathic pulmonary fibrosis (IPF) at Week 52
Endpoints: Change from baseline in absolute FVC (mL) at Week 52
Secondary Outcome
Outcome
TimePoints
1. To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression
2. To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with & without background therapy at baseline with IPF at Week 52.
3. To characterize the effect of bexotegrast versus placebo after 52 weeks of treatment on overall symptom & functional improvement associated with IPF
4. To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography (HRCT) at Week 52
5. To characterize the safety & tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment
Endpoints: Change from baseline in absolute FVC (mL) at Week 52
Target Sample Size
Total Sample Size="1113" Sample Size from India="56" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
13/12/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
16/11/2023
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Other (Terminated)
Recruitment Status of Trial (India)
Other (Terminated)
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a randomized,
double-blind, dose-ranging, placebo-controlled, operationally seamless Phase
2b/3 study to select a bexotegrast dose from two dose levels and evaluate the
efficacy and safety of 2 doses of bexotegrast (ie, 160 and 320 mg) taken for 52
weeks by participants with IPF taking and not taking background therapy (ie,
nintedanib or pirfenidone). Participants will be randomized in 3 groups with a
separate data analysis for Group 1 (Phase 2b dose selection) and a separate
data analysis for Groups 2 and 3 (Phase 3 dose confirmation) with no data
sharing between analyses. The key purposes of each group are: Group 1 (Phase
2b): • Dose selection (160 or 320 mg) for further study by characterizing
efficacy and safety of bexotegrast Group 2 (Phase 3): • To allow a seamless
transition from Group 1 to Group 3 by continuing enrollment and data collection
in the study during Group 1 treatment period and data analysis (operationally
seamless component) • Enrollment in Group 2 will be country specific depending
on health authority approval Group 3 (Phase 3): • Establish the efficacy and
safety of bexotegrast at the selected dose. The final analysis set will
include: o Group 2 participants â–ª Randomized to placebo â–ª Randomized to the
selected dose o All Group 3 participants The study will consist of an up to
35-day Screening Period, a 52-week Treatment Period, and a 14-day Safety
Follow-up Period.