A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01629667
• Date of registration: 12/06/2012
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
• Scientific title: A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: October 2012
• Target sample size: 409
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01629667
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, Israel, Korea, Republic of, Peru, United States

Contacts

• Name: Joseph Parker, MD
• Affiliation: MedImmune LLC

Key inclusion & exclusion 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)



Age minimum: 50 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Biological: Tralokinumab

Other: Placebo

Primary Outcome(s)

Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 [Time Frame: Baseline and Week 52]

Secondary Outcome(s)

Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 [Time Frame: Baseline, Week 52 and 72]

Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 [Time Frame: Baseline, Week 52 and 72]

Mean Serum Concentration of Tralokinumab [Time Frame: Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88]

Number of Participants With Clinical Global Impression of Change Scores [Time Frame: Week 72]

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [Time Frame: From the start of study treatment through Week 88]

Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72 [Time Frame: Baseline and Week 72]

Change From Baseline in Lung Volumes Through Week 72 [Time Frame: Baseline, Week 52 and 72]

Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) [Time Frame: Week 72]

Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72 [Time Frame: Baseline and Week 72]

Change From Baseline in Percent-predicted FEV1 Through Week 72 [Time Frame: Baseline, Week 52 and 72]

Percentage of Participants With Adjudicated Hospitalization [Time Frame: Week 52 and 72]

Number of Participants With Clinical Global Impression of Severity Scores [Time Frame: Week 72]

Percentage of Participants With Adjudicated Mortality [Time Frame: Week 52 and 72]

Percentage of Participants With Disease Progression [Time Frame: Week 52 and 72]

Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 [Time Frame: Baseline, Week 52 and 72]

Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 [Time Frame: Baseline, Week 52 and 72]

Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events [Time Frame: From the start of study treatment through Week 88]

Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab [Time Frame: From the start of study treatment through Week 88]

Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events [Time Frame: From the start of study treatment through Week 88]

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 [Time Frame: Baseline, Week 52 and 72]

Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) [Time Frame: Week 72]

Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 [Time Frame: Baseline and Week 68]

Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72 [Time Frame: Baseline and Week 72]

Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events [Time Frame: From the start of study treatment through Week 88]

Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations [Time Frame: Week 52 and 72]

Secondary ID(s)

CD-RI-CAT-354-1066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01629667