Study of ORJ-001 for the Treatment of IPF

NCT07869147 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ORJ-001-01
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; IPF; ORBIT; Fibrosing Interstitial Pneumonia; UIP

Outcome Measures

Primary Outcomes (9)

• Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs)

  Number of participants experiencing at least one treatment-emergent adverse event.

  From first dose through Safety Follow-up Visit, up to 12 weeks.

• Part A: Safety and Tolerability of ORJ-001: Severity of Treatment-Emergent Adverse Events (TEAEs)

  Severity of treatment-emergent adverse events as graded according to CTCAE v6.0.

  From first dose through Safety Follow-up Visit, up to 12 weeks.

• Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Systolic Blood Pressure

  Change from baseline in systolic blood pressure measured in millimeters of mercury (mmHg).

  Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.

• Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Body Temperature

  Change from baseline in body temperature measured in degrees Celsius (°C).

  Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.

• Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Heart Rate

  Change from baseline in heart rate measured in beats per minute (bpm).

  Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.

• Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Respiratory Rate

  Change from baseline in respiratory rate measured in breaths per minute.

  Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.

• Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Oxygen Saturation

  Change from baseline in oxygen saturation measured as percentage (% SpO₂).

  Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.

• Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Corrected QT Interval

  Change from baseline in corrected QT interval (QTc) measured by electrocardiogram (ECG) in milliseconds (ms).

  Baseline, Week 4, Week 12, and Safety Follow-up Visit up to 12 weeks.

• Part B: Change from Baseline in Forced Vital Capacity (FVC)

  Change from baseline in FVC measured by spirometry at Week 12.

  Baseline to Week 12

Secondary Outcomes (2)

• Part B: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC%)

  Baseline to Week 12.

• Part B: Time to Acute Exacerbation of IPF, Hospitalization for a Respiratory Cause, or Death

  Up to Week 12.

Study Arms (5)

Part A: ORJ-001 400 mg

EXPERIMENTAL

Participants receive ORJ-001 400 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (400 mg:200 mg:placebo).

Drug: ORJ-001; Other: Placebo

Part A: ORJ-001 200 mg

EXPERIMENTAL

Participants receive ORJ-001 200 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (active:active:placebo).

Drug: ORJ-001; Other: Placebo

Part A: Placebo

PLACEBO COMPARATOR

Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks.

Other: Placebo

Part B: ORJ-001 (Selected Dose)

EXPERIMENTAL

Participants receive the ORJ-001 dose selected based on Part A safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy data, administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Participants are randomized 1:1 to ORJ-001 or placebo.

Drug: ORJ-001; Other: Placebo

Part B: Placebo

PLACEBO COMPARATOR

Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks.

Other: Placebo

Interventions

ORJ-001 DRUG

ORJ-001 is a peptide agonist of β1 integrin administered by subcutaneous injection twice weekly. In Part A, dose levels are 200 mg and 400 mg. In Part B, a single dose level selected from Part A will be evaluated.

Part A: ORJ-001 200 mg; Part A: ORJ-001 400 mg; Part B: ORJ-001 (Selected Dose)

Placebo OTHER

Matching placebo administered by subcutaneous injection twice weekly.

Part A: ORJ-001 200 mg; Part A: ORJ-001 400 mg; Part A: Placebo; Part B: ORJ-001 (Selected Dose); Part B: Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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) 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

Sponsors & Collaborators

• Oorja Bio, Inc.: lead

Study Sites (1)

Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801, United States

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oorja Bio Medical Director

  Oorja Bio, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials

CONTACT

1 (832) 400-6140; clinicaltrials@oorjabio.com

Clinical Trials

CONTACT

clinicaltrials@oorjabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized to one treatment arm and remain in that assigned arm throughout the treatment period. In Part A, participants are assigned to ORJ-001 400 mg, ORJ-001 200 mg, or placebo. In Part B, participants are assigned to the selected ORJ-001 dose or placebo.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)