A PHASE 2, RANDOMIZED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY OF TRALOKINUMAB IN ADULTS WITH IDIOPATHIC PULMONARY FIBROSIS

Not Applicable

• Registration Number: PER-078-12
• Lead Sponsor: MedImmune, LLC, una subsidiaria perteneciente en su totalidad a AstraZeneca,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 32

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

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 < 0.70 AT THE TIME OF SCREENING (POSTBRONCHODILATADOR).
5. CHANGE IN ACTUAL MEASURED FVC (L) OF ≥ 10 % (SCREENING FVC (L) – DAY 1 FVC (L)/SCREENING FVC (L) FROM VISIT 1 (SCREENING) TO VISIT 2 (WEEK 0, DAY 1 PRIOR TO ADMINISTRATION OF INVESTIGACIONAL PRODUCT).
6. SIGNIFICANT BRONCHODILATADOR REVERSIBILITY ON SCREENING SPIROMETRY, DEFINED AS CHANGE IN FEV₁ OR FVC ≥ 12 % AND ABSOLUTE CHANGE > 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified