HZN-825 for Usual Interstitial Pneumonia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Instituto De Patologías Respiratorias, San Miguel De Tucumán, Argentina
Usual Interstitial Pneumonia+2 More
HZN-825 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called HZN-825 can improve lung function in people with idiopathic pulmonary fibrosis.

See full description

Eligible Conditions

  • Usual Interstitial Pneumonia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Usual Interstitial Pneumonia

Study Objectives

This trial is evaluating whether HZN-825 will improve 1 primary outcome and 7 secondary outcomes in patients with Usual Interstitial Pneumonia. Measurement will happen over the course of Baseline to Week 52.

Baseline to Week 52
Change from Baseline in K-BILD (King's Brief Interstitial Lung Disease) scores to Week 52
Change from Baseline in L-IPF (Living with IPF[Idiopathic Pulmonary Fibrosis]) scores to Week 52
Change from Baseline in LCQ (Leicester Cough Questionnaire) scores to Week 52
Change from Baseline in the 6MWT (Six-Minute Walk Test) results to Week 52
Change in Forced Vital Capacity (FVC) percent predicted from Baseline to Week 52
Time to first hospitalization due to respiratory distress up to Week 52
Time to first onset of the composite endpoint of PFS (progression-free survival) from Baseline up to Week 52, where progression includes decline in FVC % predicted ≥10% or death
Week 52
Proportion of Participants with decline in FVC % predicted ≥10% from Baseline at Week 52

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Usual Interstitial Pneumonia

Trial Design

3 Treatment Groups

HZN-825-300 mg twice daily (BID)
1 of 3
HZN-825 300 mg once daily (QD)
1 of 3
Placebo BID
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 360 total participants across 3 different treatment groups

This trial involves 3 different treatments. HZN-825 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

HZN-825-300 mg twice daily (BID)
Drug
Two 150 mg oral tablets given in the morning with a meal and two 150 mg oral tablets given in the evening with a meal, total daily dose 600 mg HZN-825
HZN-825 300 mg once daily (QD)
Drug
Two 150 mg oral tablets given in the morning with a meal and two matching placebo tablets given in the evening with a meal, total daily dose 300 mg HZN-825
Placebo BID
Drug
Matching placebo tablets (2) given in the morning with a meal and matching placebo tablets (2) given in the evening with a meal, total daily dose 4 placebo tablets

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 52 for reporting.

Closest Location

Clinical Research of Gastonia - Gastonia, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People between the ages of 18 and 80 years old who are male or female can be screened. show original
IPF should be diagnosed ≥1 year to ≤7 years prior to Screening, based on the ATS/ERS/JRS/ALAT guidelines. show original
HRCT scan indicates a significant amount of fibrosis, with reticulation present in more than 10% but less than 50% of the lung parenchyma, and honeycombing present in less than 25% of the lung parenchyma show original
Intolerant or not responsive to approved therapies for IPF. show original
Lung HRCTs were historically performed within 6 months prior to the Screening Visit, and were evaluated according to the minimum requirements for an IPF diagnosis by central review show original
Written informed consent.
There are treatments for IPF that are not approved yet show original
The decline in the use of approved therapies for IPF may be due to the high cost of the therapies and the uncertain benefits of the therapies. show original
This means that the forced vital capacity (FVC) is between 45% and 80% of what is considered normal. show original
The patient has a forced expiratory volume in 1 second (FEV1)/FVC ratio of ≥0.7, indicating a strong air flow. show original

Patient Q&A Section

What causes pulmonary fibrosis?

"The exact mechanisms of causation are not known. Possible causes include inhalation of dust or other particulates. Exposure to tobacco is also a leading cause. In addition, certain factors such as pulmonary malignancy, certain drugs and autoimmune disorders of the lungs are also believed to increase the risk of developing pulmonary fibrosis, especially pulmonary fibrosis secondary to autoimmune bronchopulmonary aspergillosis (ABPA).\n" - Anonymous Online Contributor

Unverified Answer

How many people get pulmonary fibrosis a year in the United States?

"In the US population with pulmonary fibrosis, between 2-5% are reported to have a family history of the disease, 3–7% have had a first degree relative with pulmonary fibrosis, and 4% have never received an occupational diagnosis of the disease. The percentage of people with pulmonary fibrosis is anticipated to increase over time." - Anonymous Online Contributor

Unverified Answer

What are the signs of pulmonary fibrosis?

"Results from a recent paper suggest the presence of fibrosis in patients with interstitial lung disease whose disease is clinically indistinguishable from those with idiopathic pulmonary fibrosis; the latter should be included in the differential of this disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pulmonary fibrosis?

"Most patients with [idiopathic pulmonary fibrosis](https://www.withpower.com/clinical-trials/idiopathic-pulmonary-fibrosis) receive no specific treatment. They are generally treated only with antibiotics and/or steroid medication if they do not improve after 3 months. Since the disease progresses slowly, even in cases of optimal treatment, patients with idiopathic pulmonary fibrosis usually live an active life long and they will have to live with a chronic disease. In some cases, the disease may be a sign of the underlying cause, so if the cause is known and treated adequately, the disease responds and is cured. In some rare cases of pulmonary fibrosis, a successful transplant of lung tissue with a functioning lung can be done, which will lead to improvement in the quality of life of the patient." - Anonymous Online Contributor

Unverified Answer

What is pulmonary fibrosis?

"Pulmonary fibrosis occurs when the scarring caused by the abnormal remodeling of alveoli in the lungs affects air ventilation and breathing capabilities. It is a disease of the lung that causes abnormal scarring leading to progressive loss of lung function. There are many subtypes of pulmonary fibrosis, most of which are idiopathic. It is considered a type of chronic interstitial lung disease." - Anonymous Online Contributor

Unverified Answer

Can pulmonary fibrosis be cured?

"In all four subjects, lung fibrosis was resolved after the discontinuation of steroids. Thus, this form of fibrosis may be treated, in part, by discontinuing the steroid. Further, steroids may be needed to prevent progression of the other types of fibrosis." - Anonymous Online Contributor

Unverified Answer

What does hzn-825 usually treat?

"Hzn-825 is a novel anti-inflammatory, immunosuppressive drug. It exerts its effect through the suppression of both Th1 and Th17 cells and is thus effective in several indications, in particular SLE." - Anonymous Online Contributor

Unverified Answer

What is hzn-825?

"Data from a recent study indicate that Hzn-825 may be a promising molecule of drug candidates for the treatment of lung diseases and the management of chronic pulmonary inflammatory diseases." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving hzn-825?

"Hzn-825 is not efficacious in patients with chronic interstitial lung disease; the results of the present trial do not support the use of Hzn-825 in patients with this devastating disease. The clinical trials of Hzn do not appear to be sufficiently powered in chronic interstitial lung disease or to be designed properly." - Anonymous Online Contributor

Unverified Answer

Does pulmonary fibrosis run in families?

"The occurrence of PF in relatives of the same sex, with or without the simultaneous development of lung disease raises questions on whether genetic predisposition is involved in the etiology of the lung disease and on the possibility of a common environmental factor that accounts for the development of PF and lung disease in a consanguineous environment." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in hzn-825 for therapeutic use?

"The current development of the most attractive Zn-dithiophosphate compounds, such as Zn-DTP, Zn-DTPA and zinc-DNP, do not offer a satisfactory option as a therapeutic agent against ILD." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets pulmonary fibrosis?

"There is variation among age groups in the percentage of pulmonary fibrosis that occurs in a population. There are some gender differences in the susceptibility to pulmonary fibrosis in certain age groups but not others. The risk of pulmonary fibrosis appears to increase with age, and, by the age of 50 years, nearly half of the cohort of Caucasian men and 2/3 of Caucasian women has pulmonary fibrosis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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