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

MedImmune

Status and phase: Terminated; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Biological: Tralokinumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01629667

CD-RI-CAT-354-1066

Details and patient eligibility

About

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.

Full 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

Enrollment: 409 patients

Sex: All

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

409 participants in 3 patient groups, including a placebo group

Tralokinumab 400 milligram (mg)

Experimental group

Description:

Participants will receive Tralokinumab 400 mg intravenous (IV) infusion Q4W for 68 Weeks.

Treatment:

Biological: Tralokinumab

Biological: Tralokinumab

Tralokinumab 800 mg

Experimental group

Description:

Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Treatment:

Biological: Tralokinumab

Biological: Tralokinumab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.

Treatment:

Other: Placebo