[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659726":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":63,"studyPopulation":49,"armGroups":64,"interventions":88,"overallOfficials":99,"centralContacts":103,"locations":110,"responsibleParty":125,"collaborators":49,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":49,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":49,"enrollmentInfo":136,"targetDuration":49,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":113,"whyStopped":49,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Oorja Bio, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":40,"otherOutcomes":49},[9,13,16,20,23,26,29,32,36],{"measure":10,"description":11,"timeFrame":12},"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.",{"measure":14,"description":15,"timeFrame":12},"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.",{"measure":17,"description":18,"timeFrame":19},"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.",{"measure":21,"description":22,"timeFrame":19},"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).",{"measure":24,"description":25,"timeFrame":19},"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).",{"measure":27,"description":28,"timeFrame":19},"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.",{"measure":30,"description":31,"timeFrame":19},"Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Oxygen Saturation","Change from baseline in oxygen saturation measured as percentage (% SpO₂).",{"measure":33,"description":34,"timeFrame":35},"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.",{"measure":37,"description":38,"timeFrame":39},"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",[41,45],{"measure":42,"description":43,"timeFrame":44},"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.","Baseline to Week 12.",{"measure":46,"description":47,"timeFrame":48},"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.","Up to Week 12.",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":49,"timePerspective":49,"maskingInfo":55},"RANDOMIZED","PARALLEL","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.","TREATMENT",{"masking":56,"maskingDescription":57,"whoMasked":58},"QUADRUPLE","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",[59,60,61,62],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This Phase 2a\u002F2b, randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety, tolerability, and efficacy of ORJ-001 administered subcutaneously twice weekly in adults with IPF. The study consists of two parts. Part A will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of two dose levels of ORJ-001 compared with placebo over 12 weeks of treatment. Data from Part A will be reviewed by an independent Data Monitoring Committee to select the dose for Part B. Participants in Part A will not continue into Part B; Part B will enroll a separate cohort of participants. Part B will evaluate the efficacy of the selected ORJ-001 dose compared with placebo, with the primary efficacy endpoint being change from baseline in forced vital capacity (FVC) at Week 12. Secondary and exploratory assessments include percent predicted FVC, time to acute IPF exacerbation, respiratory hospitalization or death, patient-reported outcomes, pharmacokinetics, and biomarkers of fibrosis. Adults aged 40 years or older with confirmed IPF and adequate pulmonary function who are receiving stable antifibrotic standard-of-care therapy, or who have previously discontinued such therapy due to tolerability or lack of response, may be eligible to participate.",[65,72,76,81,85],{"label":66,"type":67,"description":68,"interventionNames":69},"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).",[70,71],"Drug: ORJ-001","Other: Placebo",{"label":73,"type":67,"description":74,"interventionNames":75},"Part A: ORJ-001 200 mg","Participants receive ORJ-001 200 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (active:active:placebo).",[70,71],{"label":77,"type":78,"description":79,"interventionNames":80},"Part A: Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks.",[71],{"label":82,"type":67,"description":83,"interventionNames":84},"Part B: ORJ-001 (Selected Dose)","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.",[70,71],{"label":86,"type":78,"description":79,"interventionNames":87},"Part B: Placebo",[71],[89,94],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":49},"DRUG","ORJ-001","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.",[73,66,82],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":49},"OTHER","Placebo","Matching placebo administered by subcutaneous injection twice weekly.",[73,66,77,82,86],[100],{"name":101,"affiliation":5,"role":102},"Oorja Bio Medical Director","STUDY_DIRECTOR",[104,109],{"name":105,"role":106,"phone":107,"phoneExt":49,"email":108},"Clinical Trials","CONTACT","1 (832) 400-6140","clinicaltrials@oorjabio.com",{"name":105,"role":106,"phone":49,"phoneExt":49,"email":108},[111],{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":49},"Clinical Research Associates of Central PA","RECRUITING","DuBois","Pennsylvania","15801","United States","US",{"type":120,"coordinates":121},"Point",[122,123],-78.76003,41.11923,{"lat":123,"lon":122},{"type":126,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100659726","phase-2-study-of-orj-001-for-the-treatment-of-ipf-100659726",false,"NCT07869147","Study of ORJ-001 for the Treatment of IPF","A Phase 2a\u002F2b, 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)","Key Inclusion Criteria:\n\n1. Male or female participants aged ≥ 40 years when signing informed consent\n2. Non-smoker or ex-smoker who has stopped smoking for \\> 6 months prior to signing informed consent\n3. 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\n4. 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\n5. 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.\n6. Negative serum pregnancy test in women of childbearing potential at the screening visit\n\nKey Exclusion Criteria:\n\n1. Participants who are treatment-naïve with respect to SOC antifibrotic therapies\n2. Women who are pregnant, nursing, or who plan to become pregnant while in the trial\n3. Major surgery (including joint surgery) within 8 weeks from screening, or planned major surgery within 4 months following randomization\n4. Presence of one or more significant concurrent medical conditions that may affect the outcome of the study per investigator judgement\n5. Participants with relevant airway obstruction, defined as pre bronchodilator forced expiratory volume in 1 second (FEV1)\u002F forced vital capacity (FVC) ratio \\\u003C 0.7 at screening\n6. Lower respiratory tract infection requiring antibiotics within 4 weeks from screening, or during the screening period (may be rescreened following recovery)\n7. Acute IPF exacerbation within 3 months from screening, or during the screening period\n8. Receiving more than 15 mg per day of prednisone during screening","ALL","40 Years",{"count":137,"type":138},95,"ESTIMATED","INTERVENTIONAL",[141],"PHASE2","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.",[144],"Idiopathic Pulmonary Fibrosis",[144,146,147,148,149],"IPF","ORBIT","Fibrosing Interstitial Pneumonia","UIP","2026-10-06",{"date":152,"type":153},"2026-10-09","ACTUAL",{"date":155,"type":138},"2026-10",{"date":157,"type":138},"2029-03",{"name":5,"class":6},1]