Idiopathic Pulmonary Fibrosis study: ORJ-001
Official title Study of ORJ-001 for the Treatment of IPF
ClinicalTrials.gov ID: NCT07869147
What this study is testing
What is ORJ-001?
an investigational subcutaneous injectable medicine being studied as a potential treatment for idiopathic pulmonary fibrosis is designed to activate β1 integrin, which may help repair lung tissue
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ORJ-001 is safe and how well it works for lung function in people with idiopathic pulmonary fibrosis.
- Who it's for
- You may be able to join if you have idiopathic pulmonary fibrosis.
- What's involved
- You would take ORJ-001 pills. You will have clinic visits to check safety and how your lungs are working.
- Time commitment
- The study lasts several months and includes multiple clinic visits.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Male or female participants aged ≥ 40 years when signing informed consent
- Non-smoker or ex-smoker who has stopped smoking for \> 6 months prior to signing informed consent
- Diagnosis of IPF, as defined by 2022 international guidelines and confirmed by centrally adjudicated finding of a definite or probable UIP pattern on...
- FVC of at least 45% of the predicted value and a DLCO, corrected for the hemoglobin level, of at least 25% and no greater than 90% of the predicted...
- If receiving SOC antifibrotic therapy, participants must be on a stable regimen of a single approved therapy for at least 60 days prior to the...
You likely can't join if
- Participants who are treatment-naïve with respect to SOC antifibrotic therapies
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Major surgery (including joint surgery) within 8 weeks from screening, or planned major surgery within 4 months following randomization
- Presence of one or more significant concurrent medical conditions that may affect the outcome of the study per investigator judgement
- Participants with relevant airway obstruction, defined as pre bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC)...
- Lower respiratory tract infection requiring antibiotics within 4 weeks from screening, or during the screening period (may be rescreened following...
See the full eligibility criteria
- Male or female participants aged ≥ 40 years when signing informed consent
- Non-smoker or ex-smoker who has stopped smoking for \> 6 months prior to signing informed consent
- Diagnosis of IPF, as defined by 2022 international guidelines and confirmed by centrally adjudicated finding of a definite or probable UIP pattern on HRCT of the chest.
- FVC of at least 45% of the predicted value and a DLCO, corrected for the hemoglobin level, of at least 25% and no greater than 90% of the predicted value.
- If receiving SOC antifibrotic therapy, participants must be on a stable regimen of a single approved therapy for at least 60 days prior to the screening visit.
- Negative serum pregnancy test in women of childbearing potential at the screening visit Key
- Participants who are treatment-naïve with respect to SOC antifibrotic therapies
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Major surgery (including joint surgery) within 8 weeks from screening, or planned major surgery within 4 months following randomization
- Presence of one or more significant concurrent medical conditions that may affect the outcome of the study per investigator judgement
- Participants with relevant airway obstruction, defined as pre bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio \< 0.7 at screening
- Lower respiratory tract infection requiring antibiotics within 4 weeks from screening, or during the screening period (may be rescreened following recovery)
- Acute IPF exacerbation within 3 months from screening, or during the screening period
- Receiving more than 15 mg per day of prednisone during screening
The study team makes the final eligibility decision.
Where it is enrolling
- Doral, Florida, United States
- DuBois, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Doral, Florida, United States; DuBois, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.