None listed
Conditions
Interventions
APPROXIMATELY 186 SUBJECTS WILL BE RANDOMIZED IN A 1:1:1 RATIO TO ONE OF TWO DOSES OF IV TRALOKINUMAB (400 OR 800) OR PLACEBO Q4W FOR 68 WEEKS FOR A TOTAL OF 18 DOSES AS FOLLOWS.
. TREATMENT ARM 1:
AT WEEK 72 FOR ASSESSMENT OF THE EFFICACY ENDPOINTS AND FOLLOW-UP, AND FOR SAFETY FOLLOW-UP VISITS AL WEEKS 76, 80 AND 84. SEE FIGURE 3.1-1 FOR STUDY FLOW DIAGRAM.
Sponsors
MedImmune, LLC, una subsidiaria perteneciente en su totalidad a AstraZeneca,
Eligibility
Age
50 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. AGE 50-79 YEARS AT THE TIME OF SCREENING. 2. WRITTEN INFORMED CONSENT AND ANY LOCALLY REQUIRED AUTHORIZATION (EG, HIPAA IN THE USA, EU DATA PRIVACY DIRECTIVE IN THE EU) OBTAINED FROM THE SUBJECT PRIOR TO PERFORMING ANY PROTOCOL-RELATED PROCEDURES, INCLUDING SCREENING EVALUATIONS. 3. IPF DIAGNOSIS FOR ≤ 4 YEARS PRIOR TO VISIT 1 (SCREENING). CONFIRMATION OF DIAGNOSIS OF IPF IN ACCORDANCE WITH SECTION 5.2.1 IS REQUIRED FOR SUBJECT INCLUSION. 4. MILD TO MODERATE IPF TO INCLUDE ALL OF THE FOLLOWING AT SCREENING: A) FVC ≥ 50 % AND ≤ 90 % PREDICTED NORMAL. B) PARTIAL PRESSURE OF OXYGEN IN ARTERIAL BLOOD (PAO2) OF ≥ 55 MMHG ON ROOM AIR OR 50 MMHG AT HIGH ALTITUDE (> 2,500 METERS), OR OXYGEN SATURATION BY PULSE OXIMETRY (SPO2) OF ≥ 90 % ON ROOM AIR AT REST. C) HEMOGLOBIN-CORRECTED DIFFUSION CAPACITY FOR CARBON MONOXIDE (DLCO) ≥ 30 % AND ≤ 90 % PREDICTED NORMAL. 5. BE ABLE TO WALK ≥ 100 METERS UNASSISTED. 6. BODY WEIGHT 45-145 KG. 7. ABLE TO AND WILLIGNESS TO COMPLETE THE STUDY AS REQUIRED BY THE PROTOCOL. 8. ABLE TO READ AND WRITE IN ORDER TO COMPLETE QUESTIONNAIRES, AND ABLE TO USE THE ELECTRONIC DIARY (EDIARY) DEVICE.
Exclusion criteria
Exclusion criteria: 1. HISTORY OF CLINICALLY SIGNIFICANT ENVIRONMENTAL EXPOSURE (EG, DOMESTIC AND OCCUPATIONAL) TO A KNOWN CAUSE OF PUMONARY FIBROSIS. 2. DIAGNOSIS OF CONNECTIVE TISSUE DISEASE OR DRUG TOXICITY AS THE LIKELY CAUSE OF THE INTERSTITIAL DISEASE. 3. CURRENTLY LISTED FOR LUNG TRANSPLANTION. 4. A FEV₁/FVC RATIO 200 ML. 7. THE EXTENT OF EMPHYSEMA ON THE HRTC IS GREATER THAN THE EXTENT OF FIBROSIS. 8. SUBJECTS WHO IN THE OPINION OF THE INVESTIGATOR HAVE EVIDENCE OF ACTIVE TB, EITHER TREATED OR UNTREATED. OR LATENT TB WITHOUT COMPLETION OF AN APPROPIATE COURSE OF TREATMENTOR APPROPIATE ONGOING PROPHYLACTIC TREATMENT. EVALUATION WILL BE ACCORDING TO THE LOCAL STANDARD OF CARE AS DETERMINED BY LOCAL GUIDELINES AND MAY CONSIST F MEDICAL HISTORY AND PHYSICAL EXAMINATIONS, CHEST X-RAY, SPUTUM STAIN AND/OR CULTURE, AND/OR TB TEST (EG, PURIFIED PROTEIN DERIVATIVE OR QUANTIFERON TEST).
Countries
Australia, Canada, Israel, Korea North, United States
Contacts
Public ContactLUIS MIGUEL MELENDEZ
PPD Peru S.A.C.
Outcome results
None listed