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Phase 2RecruitingAge-related condition

Study of ORJ-001 for the Treatment of IPF

A Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Tolerability (Part A), and Efficacy (Part B), of ORJ-001 in Patients With Idiopathic Pulmonary Fibrosis (ORBIT-IPF)

Sponsor
Oorja Bio, Inc. (Industry)
Enrolment
95 planned
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
ORJ-001; Placebo
Ages
adults, older adults
Registry
NCT07869147

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs)
  • Part A: Safety and Tolerability of ORJ-001: Severity of Treatment-Emergent Adverse Events (TEAEs)
  • Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Systolic Blood Pressure
  • Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Body Temperature

History

  1. Study completion expected

  2. Primary completion expected

  3. Started

  4. Last registry update

  5. Registered