Health TrialsbyHealthPanel

Study of ORJ-001 for the Treatment of IPF

ConditionIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorOorja Bio, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Other intervention

    Matching placebo administered by subcutaneous injection twice weekly.

Treatment groups

95 Participants
are divided into 5 treatment groups
Group A: Part A: ORJ-001 400 mgExperimental treatment 2 interventions
Group B: Part A: ORJ-001 200 mgExperimental treatment 2 interventions
Group C: Part A: PlaceboPlacebo comparator 1 intervention
Group D: Part B: ORJ-001 (Selected Dose)Experimental treatment 2 interventions
Group E: Part B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From first dose through Safety Follow-up Visit, up to 12 weeks.
2

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.

Time frame
From first dose through Safety Follow-up Visit, up to 12 weeks.
3

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).

Time frame
Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
4

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).

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

Secondary outcomes

1

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

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

Time frame
Baseline to Week 12.
2

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

Time, in days, to first occurrence of acute IPF exacerbation, hospitalization for a respiratory cause, or death.

Time frame
Up to Week 12.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oorja Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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