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NCT07869147

Study of ORJ-001 for the Treatment of IPF

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 2 versions: 2 with changes below.

  1. Study sites: 1 to 2
  2. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline, Week 4, Week 12, and Safety Follow-up Visit up to 12 weeks.
Part B: Change from Baseline in Forced Vital Capacity (FVC)
Timeframe: Baseline to Week 12

Secondary (2)

Part B: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC%)
Part B: Time to Acute Exacerbation of IPF, Hospitalization for a Respiratory Cause, or Death

Arms and interventions

Part A: ORJ-001 400 mgExperimental

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).

Part A: ORJ-001 200 mgExperimental

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

Part A: PlaceboPlacebo comparator

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

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.

Part B: PlaceboPlacebo comparator

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

Drugs: ORJ-001

Other: Placebo

Sites

2 sites in 1 country