MedImmune

Overview

Status: Not yet recruiting
Keywords: IPF , Idiopathic Pulmonary Fibrosis , Pulmonary Disease , Adult
IRB Number: 00063757
Specialty: Pulmonary
Sub Specialties:

Brief Summary

Primary Objective:

The primary objective of this study is to determine the effect of two intravenous (IV) doses of tralokinumab compared to placebo on the change from baseline in percent-predicted forced vital capacity (FVC) in adult subjects 50-79 years of age with mild to moderate idiopathic pulmonary fibrosis (IPF).

Secondary Objectives:

  • To evaluate the safety and tolerability of tralokinumab
  • To evaluate the effect of tralokinumab on other measures of disease (ie, progression-free survival [PFS], physiologic measures, clinical measures, IPF symptoms and respiratory-related health status)
  • To evaluate the pharmacokinetics (PK) and immunogenicity (IM) of IV tralokinumab in subjects with IPF.
  • To determine the optimal dose of tralokinumab to be used in future clinical studies

Exploratory Objectives:

  • To evaluate the effect of tralokinumab on biomarkers in blood and bronchial fluid and cells related to IPF. These data will not be included in the clinical study report (CSR).
  • To evaluate the role of serum periostin to identify responders to tralokinumab. These data will be included in the CSR.
  • To evaluate the role of other potential biomarkers to identify responders to tralokinumab. These data will not be included in the CSR.
  • To evaluate the effect of tralokinumab on general health status. These data will be included in the CSR.
  • To evaluate the effect of tralokinumab on health resource utilization. These data will be included in the CSR.

Principal Investigator: Mary Scholand
Department: Pulmonary
Co Investigator:

Contact Information

Name:Judy Carle
Phone: 801-581-5864
Email: judy.carle@hsc.utah.edu

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 ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance with Section 5.2.1 of the protocol is required for subject inclusion
  4. Mild to moderate IPF to include all of the following at screening:
  1. FVC ≥ 50% and ≤ 90% predicted normal
  2. Partial pressure of oxygen in arterial blood (PaO2) of ≥ 55 mmHg on room air or 50 mmHg at high altitude (> 1,500 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% and ≤ 90% predicted normal
  1. Be able to walk ≥ 100 meters unassisted
  2. Body weight 45-145 kg
  3. Able to and willingness to complete the study as required by the protocol
  4. Able to read and write in order to complete questionnaires, and able to use the electronic diary (eDiary) device
  5. Females must be of nonchildbearing potential (defined as surgically sterilized [ie, bilateral tubal ligation, bilateral oophorectomy or complete hysterectomy] or postmenopausal [defined as 12 months with no menses with out an alternative medical cause] with a follicle-stimulating hormone [FSH] > 25.8 IU/L)
  6. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception (see Table 4.2.1-1 of the protocol below) from Day 1 through Week 84
Highly Effective Methods of Contraception
Barrier Methods Hormonal Methods
Male condom plus spermicide Implants
Copper T intrauterine device Hormone shot or injection
  Combined pill
  Minipill
  Patch
  Mirena (Levonorgesterel intrauterine device/system


 

Exclusion Criteria

Exclusion Criteria:

  1. History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis
  2. Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease
  3. Currently listed for lung transplantation
  4. A FEV1/FVC ratio < 0.70 at the time of screening (postbronchodilator)
  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 investigational product)
  6. Significant bronchodilator reversibility on screening spirometry, defined as change in FEV1 or FVC ≥ 12% and absolute change > 200 mL
  7. The extent of emphysema on the HRCT 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 appropriate course of treatment or appropriate ongoing prophylactic treatment. Evaluation will be according to the local standard of care as determined by local guidelines and may consist of medical history and physical examinations, chest x-ray, sputum stain and/or culture, and/or TB test (eg, purified protein derivative or QuantiFeron test)
  9. Medical history, evidence of an uncontrolled intercurrent illness other than IPF, that in the opinion of the investigator and/or medical monitor may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study
  10. Any clinically relevant abnormal findings in physical examination, electrocardiogram (ECG), vital signs, hematology, clinical chemistry, or urinalysis during the screening period, which in the opinion of the investigator or medical monitor may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study
  11. Evidence of a clinically significant infection or receiving treatment with antibiotics or antiviral medications at Visit 2 (Week 0, Day 1)
  12. A history of an untreated systemic helminth parasitic infestation; diagnosis of a helminth parasitic infestation within 6 months prior to Visit 1 (screening); history of living with a person known to have had a helminth parasitic infestation within 12 months prior to Visit 1 (screening)
  13. History of chronic alcohol or drug abuse within 12 months prior to Visit 1 (screening), or any condition associated with poor compliance as judged by the investigator
  14. History of any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A or IgG subclass deficiency
  15. History of cancer, except as follows:
  1. In situ carcinoma of the cervix, subjects treated with apparent success with curative therapy ≥ 12 months prior to Visit 1 (screening); or
  2. Basal cell carcinoma treated with apparent success with curative therapy; or
  3. For other malignancies, subjects treated with apparent success with curative therapy ≥ 5 years prior to Visit 1 (screening)
  1. Positive hepatitis B surface antigen or hepatitis C virus antibody serology. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to participate in the study
  2. A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject’s verbal report
  3. Major surgery within 8 weeks prior to Visit 1 (screening), or planned inpatient surgery or hospitalization during the study period
  4. Concurrent enrollment in another clinical study where the subject is receiving an investigational product
  5. Receipt of tralokinumab in the past
  6. Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to Visit 1 (screening), whichever is longer
  7. Receipt of any investigational nonbiologic agent within 3 months or 5 half lives prior to Visit 1 (screening), whichever is longer (except medications specifically noted in Exclusion No.23)
  8. Use of the following medications:
  1. Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine) 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)
  1. Known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy
  2. Any condition other than IPF that, in the opinion of the investigator, is likely to result in death within 1 year after randomization in the study
  3. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals