Lung Diseases, Interstitial Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase 2/3 Study of Efficacy and Safety of Olokizumab in Subjects With Progressive Fibrosing Interstitial Lung Diseases
The purpose of this study is to evaluate efficacy and safety of olokizumab (OKZ) compared to placebo in patients progressive fibrosing Interstitial lung diseases (ILD).
This is a phase 2/3 study with double-blind parallel-group adaptive design. The study will include the following periods: 1. Screening period (4 weeks) Screening period (before the first administration of the test drug). Before being included in the study, patients will be provided with complete information about this clinical trial and signs the Informed consent Form (IF). After that the researcher will decide whether or not the patient can be randomized into the study. 2. Double-blind Treatment period (48 weeks). Following the completion of a Treatment period, all patients will be enrolled in Follow-up Period (FU). 3. Follow-up Period (24 weeks). During the FU Period, patients will visit study sites after 4,12 and 24 weeks after the end of the Treatment Period to complete FU-1 (Week 52), FU-2 (Week 60) and FU-3 (Week 72) visits. The overall study duration for the patients will be approximately 76 weeks (including the 4 weeks screening period) The analysis will be conducted in two sequential steps: - the interim analysis after 60 percent (%) of patients have completed the Treatment period (not including the FU period) - the final analysis when all patients have completed all periods (the Treatment and the FU periods). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04119115 -
Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases
|
||
| Active, not recruiting |
NCT04559581 -
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
|
||
| Recruiting |
NCT05151640 -
INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
|
||
| Recruiting |
NCT02543073 -
MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
|
Phase 1/Phase 2 | |
| Completed |
NCT02251964 -
Rituximab in Interstitial Pneumonitis
|
Phase 2/Phase 3 | |
| Terminated |
NCT01432080 -
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
|
Phase 2 | |
| Completed |
NCT01442779 -
Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
| Recruiting |
NCT05596760 -
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
|
N/A | |
| Recruiting |
NCT05866198 -
Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
|
N/A | |
| Active, not recruiting |
NCT05321082 -
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
|
Phase 3 | |
| Completed |
NCT04016168 -
Idiopathic Pulmonary Fibrosis and Serum Bank
|
||
| Recruiting |
NCT00258583 -
Dorothy P. and Richard P. Simmons Center for ILD Research Registry
|
||
| Recruiting |
NCT05855109 -
Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
|
||
| Completed |
NCT05719233 -
Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
|
||
| Recruiting |
NCT04159129 -
Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients
|
||
| Completed |
NCT03313180 -
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
|
Phase 3 | |
| Completed |
NCT05065190 -
A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis
|
Phase 3 | |
| Completed |
NCT03136120 -
Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
|
||
| Recruiting |
NCT04930666 -
BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease
|
||
| Recruiting |
NCT05503030 -
Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
|