Clinical trial NCT01629667: A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
Official title: A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 409
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.

Detailed description: The primary objective of this study is to determine the effect of multiple doses of tralokinumab on pulmonary function in adults with mild to moderate IPF

Eligibility criteria: Key Inclusion Criteria:

* 1) IPF diagnosis for \<= 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance is required for subject inclusion 2) Confirmed diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if required) 3)Mild to moderate IPF to include all of the following at screening:

  1. FVC \>= 50% predicted normal
  2. Partial pressure of oxygen in arterial blood (PaO2) of \>= 55 mmHg on room air or 50 mmHg at high altitude (\> 1500 meters), or oxygen saturation by pulse oximetry (SpO2) of \>= 90%on room air at rest
  3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) \>= 30% predicted normal 4) Be able to walk \>= 100 meters unassisted

Key Exclusion Criteria:

1. A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)
2. The extent of emphysema on the HRCT is greater than the extent of fibrosis.
3. Currently listed for lung transplantation
4. Use of the following medications:

   1. Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid) within 3 months prior to Visit 1 (screening). Oral prednisone \<= 15 mg/day (or equivalent oral corticosteroid) is allowed for chronic use if subject was on a stable dose at least 30 days prior to Visit 1 (screening)
   2. Pirfenidone within 4 weeks prior to Visit 1 (screening)
   3. N-acetylcysteine within 4 weeks prior to Visit 1 (screening)
   4. Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)

Primary outcomes:
measure: Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From the start of study treatment through Week 88
measure: Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events
timeFrame: From the start of study treatment through Week 88
measure: Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events
timeFrame: From the start of study treatment through Week 88
measure: Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events
timeFrame: From the start of study treatment through Week 88
measure: Percentage of Participants With Disease Progression
timeFrame: Week 52 and 72
measure: Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72
timeFrame: Baseline, Week 52 and 72
measure: Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72
timeFrame: Baseline, Week 52 and 72
measure: Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68
timeFrame: Baseline and Week 68
measure: Change From Baseline in Lung Volumes Through Week 72
timeFrame: Baseline, Week 52 and 72
measure: Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations
timeFrame: Week 52 and 72
measure: Percentage of Participants With Adjudicated Mortality
timeFrame: Week 52 and 72
measure: Percentage of Participants With Adjudicated Hospitalization
timeFrame: Week 52 and 72
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72
timeFrame: Baseline, Week 52 and 72
measure: Change From Baseline in Percent-predicted FEV1 Through Week 72
timeFrame: Baseline, Week 52 and 72
measure: Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72
timeFrame: Baseline, Week 52 and 72
measure: Number of Participants With Clinical Global Impression of Severity Scores
timeFrame: Week 72
measure: Number of Participants With Clinical Global Impression of Change Scores
timeFrame: Week 72
measure: Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72
timeFrame: Baseline, Week 52 and 72
measure: Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72
timeFrame: Baseline and Week 72
measure: Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)
timeFrame: Week 72
measure: Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)
timeFrame: Week 72
measure: Mean Serum Concentration of Tralokinumab
timeFrame: Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88
measure: Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab
timeFrame: From the start of study treatment through Week 88
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: La Jolla
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Chesterfield
country: United States
facility: Research Site
state: Missouri
city: Summit
country: United States
facility: Research Site
state: New Jersey
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: McAllen
country: United States
facility: Research Site
state: Texas
city: McKinney
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Box Hill
country: Australia
facility: Research Site
city: Camperdown
country: Australia
facility: Research Site
city: Concord
country: Australia
facility: Research Site
city: Darlinghurst
country: Australia
facility: Research Site
city: Frankston
country: Australia
facility: Research Site
city: Glen Osmond
country: Australia
facility: Research Site
city: New Lambton
country: Australia
facility: Research Site
city: Parkville
country: Australia
facility: Research Site
city: Prahran
country: Australia
facility: Research Site
city: Woodville South
country: Australia
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Petach Tikva
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Cercado de Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: Joseph Parker, MD
role: STUDY_DIRECTOR
References:
citation: Parker JM, Glaspole IN, Lancaster LH, Haddad TJ, She D, Roseti SL, Fiening JP, Grant EP, Kell CM, Flaherty KR. A Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2018 Jan 1;197(1):94-103. doi: 10.1164/rccm.201704-0784OC.