New IPF drug ORJ-001 tested in adults with IPF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2a/2b, randomized, double-blind, placebo-controlled multicenter study of ORJ-001 given subcutaneously twice weekly in adults with IPF. Part A compares two dose levels to placebo over 12 weeks to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, with an independent committee selecting the dose for Part B. Part B then evaluates the efficacy of the chosen dose versus placebo, focusing on change in FVC at Week 12 and including secondary outcomes such as other lung function measures, time to IPF exacerbation or death, patient-reported outcomes, pharmacokinetics, and fibrosis biomarkers. Eligibility includes adults 40+ with confirmed IPF, adequate lung function, and stable antifibrotic therapy or prior intolerance/nonresponse to it.

Why it matters

Who can join: the full rules

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

Where it's running

• Innova Pharma Research, LLC
  Doral, Florida, United States Recruiting
• Clinical Research Associates of Central PA
  DuBois, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials
• Email: clinicaltrials@oorjabio.com
• Phone: 1 (832) 400-6140

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.