95 Participants NeededMy employer runs this trial

ORJ-001 for IPF

Recruiting at 1 trial location
CT
Overseen ByClinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Oorja Bio, Inc.
Must be taking: Antifibrotics
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ORJ-001, for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. The goal is to determine the safety of ORJ-001 and its potential to improve lung function. The trial consists of two parts: the first assesses the drug's tolerability, and the second examines its impact on lung health. Participants should have an IPF diagnosis and have been managing it for some time, particularly if current treatments are ineffective. Those who have stopped smoking for at least six months may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that ORJ-001 is likely to be safe for humans?

Research has shown that ORJ-001 is generally safe and well-tolerated. In earlier studies, the drug reached the desired level in the body without causing major side effects. These findings support further investigation of ORJ-001 for treating idiopathic pulmonary fibrosis (IPF). However, while early results are promising, more studies are needed to fully understand its safety and effectiveness for this condition.12345

Why do researchers think this study treatment might be promising?

Most treatments for idiopathic pulmonary fibrosis (IPF) currently focus on slowing disease progression, with drugs like pirfenidone and nintedanib as the standard of care. However, ORJ-001 is unique because it is administered subcutaneously and may offer a different approach to targeting the disease. Researchers are excited because this treatment could provide a new mechanism of action, potentially improving outcomes for patients by offering an alternative to the existing oral medications. The innovative delivery method and potential enhanced efficacy are key reasons for the excitement surrounding ORJ-001.

What evidence suggests that ORJ-001 might be an effective treatment for IPF?

Research has shown that ORJ-001 could help treat idiopathic pulmonary fibrosis (IPF), a lung disease. In animal studies, this drug healed damaged lung tissue and improved lung function. Earlier studies with people demonstrated that the drug reached the needed levels in the body and was safe for patients. ORJ-001 targets specific lung cells to reduce scarring and improve lung function. These early findings offer hope that ORJ-001 might be effective for people with IPF. Participants in this trial will receive different doses of ORJ-001 or a placebo to further evaluate its safety and effectiveness.12346

Who Is on the Research Team?

OB

Oorja Bio Medical Director

Principal Investigator

Oorja Bio, Inc.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. Participants should be generally healthy aside from their IPF, and meet specific medical criteria set by the study team.

Inclusion Criteria

Non-smoker or ex-smoker who has stopped smoking for > 6 months prior to signing informed consent
I am 40 years old or older.
FVC of at least 45% of predicted value and DLCO corrected for hemoglobin level of at least 25% and no greater than 90% of predicted value, with each test repeatable once after minimum 24 hours if initial result unreliable
See 3 more

Exclusion Criteria

Presence of significant concurrent medical conditions that may affect study outcome per investigator judgement
I have never received standard antifibrotic treatments.
I have had a recent flare-up of my lung disease within the last 3 months.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive ORJ-001 or placebo subcutaneously twice weekly for 12 weeks to assess safety, tolerability, and preliminary efficacy

12 weeks
24 visits (in-person)

Treatment Part B

A separate cohort receives the selected ORJ-001 dose or placebo subcutaneously twice weekly for 12 weeks to evaluate efficacy

12 weeks
24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ORJ-001

Trial Overview

The study is testing ORJ-001, a new drug, compared to a placebo in people with IPF. The first part checks if ORJ-001 is safe and how it behaves in the body; the second part looks at whether it helps improve lung function.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: ORJ-001 (Selected Dose)Experimental Treatment2 Interventions
Group II: Part A: ORJ-001 400 mgExperimental Treatment2 Interventions
Group III: Part A: ORJ-001 200 mgExperimental Treatment2 Interventions
Group IV: Part A: PlaceboPlacebo Group1 Intervention
Group V: Part B: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oorja Bio, Inc.

Lead Sponsor

Citations

Oorja Bio Unveils Clinical Data for ORJ-001, a First-in- ...

ORJ-001 achieved therapeutic exposure and was well tolerated in Phase 1 study, lower levels of Tenascin-C,

NCT07869147 | Study of ORJ-001 for the Treatment of IPF

Part B will evaluate the efficacy of the selected ORJ-001 dose compared with placebo, with the primary efficacy endpoint being change from ...

Oorja Bio Announces Initiation of ORBIT-IPF Phase 2 ...

Preclinical studies in animal models of IPF have shown that ORJ-001 can repair damaged lung tissue and improve markers of lung function. ...

NCT07869147 | Study of ORJ-001 for the Treatment of IPF

Animal models of IPF have shown that ORJ-001 can repair damaged lung tissue and improve markers of lung function.

Oorja Bio Unveils Clinical Data for ORJ-001, a

In additional preclinical studies in animal models of pulmonary fibrosis, ORJ-001 has demonstrated reversal of fibrosis and repair of lung ...

Oorja Bio

Phase II efficacy and safety data for ORJ-001, representing the first clinical validation of the AEC2 restoration mechanism in humans.