A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis; Scarred Lungs; 10038716

• Registration Number: NL-OMON53568
• Lead Sponsor: Horizon Therapeutics Ireland DAC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

Core phase:
1. Written informed consent.
2. Male or female >=18 years of age at Screening.
3. Current diagnosis of IPF, as defined by American Thoracic Society
(ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society
(JRS)/Latin American Thoracic Society (ALAT) guidelines [Raghu et al., 2022]
and determined by central review; the date of initial diagnosis of IPF should
be <=7 years prior to Screening.
4. No recent changes or planned changes to the dose or regimen for IPF therapy,
defined as:
• Receiving a stable dose of IPF-approved therapy (i.e., nintedanib or
pirfenidone) for a minimum of 3 months prior to Day 1 with no plans to change
the background regimen during trial participation, or
• Not currently receiving background IPF-approved therapy at Screening (either
naïve to IPF-approved therapy or previously discontinued any IPF-approved
therapy at least 4 weeks prior to Day 1 or drug-specific, 5 half-lives
elimination period if longer than 4 weeks), and with no current plans to
restart treatment during trial participation
• Subjects receiving any additional agent for IPF therapy must be on a stable
regimen for at least 3 months prior to Day 1 with no current plans to change
the treatment regimen during trial participation. Any previously discontinued
therapy used to treat IPF must have been discontinued at least 4 weeks prior to
Day 1 or 5 half-lives for that specific therapy must have elapsed, whichever is
longer, with no plans to restart the therapy during trial participation.
5. Lung HRCT historically performed within 6 months prior to the Screening
Visit and according to the minimum requirements for IPF diagnosis by central
review based on subject's HRCT. If an evaluable HRCT is not available within 6
months prior to Screening, an HRCT will be performed at Screening to determine
eligibility, according to the same requirements as the historical HRCT. The
HRCT must demonstrate a usual interstitial pneumonia or probable usual
interstitial pneumonia pattern based on central review vendor interpretation.
Histopathology in combination with HRCT results supportive of an IPF or IPF
likely diagnosis according to Raghu et al., 2022 can be submitted to support
subject eligibility.
6. HRCT shows >=10% to <50% parenchymal fibrosis (reticulation) and the extent
of fibrotic changes is greater than the extent of emphysema on the most recent
HRCT scan (central reviewer determined).
7. Meets all of the following criteria during the Screening Period, as
determined by central review:
a. FVC >=45% predicted of normal
b. forced expiratory volume in 1 second (FEV1)/FVC >=0.7
c. DLCO corrected for hemoglobin is >=25% and <=90% predicted of normal
8. Estimated minimum life expectancy of >=30 months for non-IPF-related disease,
in the opinion of the Investigator.
9. Vaccinations are up to date, according to the Investigator*s discretion,
given age, comorbidities and local availability prior to trial drug dosing.
10. Willing and able to comply with the prescribed treatment protocol and
evaluations for the duration of the trial.

Extension phase:
1. Written informed consent.
2. Completed the Double-blind Treatment Period (Week 52) of the Core Phase of
the trial; subjects prematurely discontinued from trial drug in the Core Phase
of the trial for

Exclusion Criteria

Core phase:
1. Any of the following cardiovascular diseases:
a. uncontrolled, severe hypertension (>=160/100 mmHg), within 6 months of
Screening
b. myocardial infarction within 6 months of Screening
c. unstable cardiac angina within 6 months of Screening
2. Interstitial lung disease (ILD) associated with known primary diseases
(e.g., sarcoidosis, amyloidosis and coronavirus disease 2019 [COVID-19]),
connective tissue disorders (e.g., rheumatoid arthritis, systemic lupus
erythematosus, Sjogren*s, dermatomyositis, scleroderma), exposures (e.g.,
radiation, silica, asbestos and coal dust) or drugs (e.g., amiodarone).
3. Known active bacterial, viral, fungal, mycobacterial or other infection,
including tuberculosis or atypical mycobacterial disease (fungal infections of
nail beds are allowed). The subject must be 3 months beyond any acute
infection with COVID-19 if there has been a prior infection.
4. Clinically significant pulmonary hypertension requiring chronic medical
therapy.
5. Use of any of the following therapies within 4 weeks prior to Screening,
during the Screening Period or planned during the trial: prednisone at steady
dose >10 mg/day or equivalent or cyclosporine. Prednisone <=10 mg/day (or
equivalent dosing of glucocorticoids) is allowed. Change in regimen or dosage
of any immunosuppressant during the Screening Period through the end of trial
participation will require consultation with and approval by the trial Medical
Monitor. See Section 9.4.9 for full details. Avoiding the use of listed
prohibited treatments must not be considered detrimental and must be indicated
by the treating physician. Subjects must not be withdrawn from any
standard-of-care treatment that is considered necessary for the clinical
management of the subject in order to fulfill the trial eligibility
requirements.
6. Use of rifampin within 2 weeks prior to Day 1 or planned during the trial.
7. Malignant condition in the past 5 years (except successfully treated
basal/squamous cell carcinoma of the skin or cervical cancer in situ).
8. Women of childbearing potential (WOCBP) or male subjects not agreeing to use
highly effective method(s) of birth control throughout the trial and for 4
weeks after last dose of trial drug. Females must refrain from egg/ova
donation for 4 weeks after the last dose of trial drug and males must refrain
from sperm donation for 3 months after the last dose of trial drug. Women are
considered of childbearing potential if they are not postmenopausal and not
surgically sterile (documented bilateral salpingectomy, bilateral oophorectomy
or hysterectomy). A postmenopausal state is defined as no menses for 12 months
without an alternative medical cause. A high follicle-stimulating hormone
(FSH) level in the postmenopausal range may be used to confirm a postmenopausal
state in women not using hormonal contraception or hormonal replacement
therapy. However, in the absence of 12 months of amenorrhea, a single FSH
measurement is insufficient. Fertile male subjects must use a condom
throughout the trial and for 4 weeks after the last dose of trial drug. A man
is considered fertile after puberty unless permanently sterile by bilateral
orchidectomy.
9. Pregnant or lactating women and women who plan to become pregnant or breast
feed during the trial and withi

Study & Design

• Study Type: Interventional
• Study Design: Not specified