NCT07869147RecruitingPhase 2
Study of ORJ-001 for the Treatment of IPF
A Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Tolerability (Part A), and Efficacy (Part B), of ORJ-001 in Patients With Idiopathic Pulmonary Fibrosis (ORBIT-IPF)
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
ORJ-001 is a new class of drugs intended for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This is a Phase 2 study in two parts; the objective of Part A will determine if ORJ-001 is well-tolerated by patients and how long the drug stays in the body. Part B will test how well the drug affects lung function. Animal models of IPF have shown that ORJ-001 can repair damaged lung tissue and improve markers of lung function.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (estimated)
- First submitted
- 21 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Oorja Bio, Inc.
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT07869147
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 95
- From 1 Oct 2026 to the primary completion date, 31 Jan 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who are treatment-naïve with respect to SOC antifibrotic therapies
- 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
- Receiving more than 15 mg per day of prednisone during screening
Other illness
- Lower respiratory tract infection requiring antibiotics within 4 weeks from screening, or during the screening period (may be rescreened following recovery)
Other
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- 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
- Acute IPF exacerbation within 3 months from screening, or during the screening period
Who the study is looking for
- 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. The HRCT may be performed at screening or, if available, a historical HRCT obtained within 12 months from screening may be submitted for central review
- 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. Note: Each test (FVC and DLCO) may be repeated once after a minimum of 24 hours if the initial result is deemed unreliable by the investigator
- 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. Participants who have discontinued SOC antifibrotic therapy due to tolerability or lack of response may be enrolled after at least 30 days of discontinuing the SOC antifibrotic therapy.
- Negative serum pregnancy test in women of childbearing potential at the screening visit
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Innova Pharma Research, LLC Coordinator of this site? Confirm its status | Doral | United States | Recruiting |
| Clinical Research Associates of Central PA Coordinator of this site? Confirm its status | DuBois | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.