NCT07869147 Study of ORJ-001 for the Treatment of IPF

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 95 participants in total. It began in 2026-10 with a primary completion date of 2029-01.

Brief Summary

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.

Eligibility Criteria

Key Inclusion Criteria: 1. Male or female participants aged ≥ 40 years when signing informed consent 2. Non-smoker or ex-smoker who has stopped smoking for \> 6 months prior to signing informed consent 3. 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 4. 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 5. 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. 6. Negative serum pregnancy test in women of childbearing potential at the screening visit Key Exclusion Criteria: 1. Participants who are treatment-naïve with respect to SOC antifibrotic therapies 2. Women who are pregnant, nursing, or who plan to become pregnant while in the trial 3. Major surgery (including joint surgery) within 8 weeks from screening, or planned major surgery within 4 months following randomization 4. Presence of one or more significant concurrent medical conditions that may affect the outcome of the study per investigator judgement 5. 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 6. Lower respiratory tract infection requiring antibiotics within 4 weeks from screening, or during the screening period (may be rescreened following recovery) 7. Acute IPF exacerbation within 3 months from screening, or during the screening period 8. Receiving more than 15 mg per day of prednisone during screening

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