STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT ID: NCT01371305

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-16
• Study Completion Date: 2017-03-31

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as STX-100) in participants with IPF. The Secondary objectives are to estimate the pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple, escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.

Detailed Description

This study was previously posted by Stromedix, Inc. In April, 2014, sponsorship of the trial was transferred to Biogen. The study drug name was changed from STX-100 to BG00011 and the study number was changed from STX-003 to 203PF201, to align with sponsor conventions.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BG00011

Participants will receive 8 consecutive weekly doses of BG00011

Group Type: EXPERIMENTAL

BG00011

Intervention Type: DRUG

BG00011 will be administered at varying doses via subcutaneous (SC) injection

Placebo

Participants will receive 8 consecutive weekly doses of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.

Interventions

BG00011

BG00011 will be administered at varying doses via subcutaneous (SC) injection

Intervention Type: DRUG

Placebo

Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.

Intervention Type: DRUG

Other Intervention Names

STX-100

Eligibility Criteria

Inclusion Criteria

1. Clinical features consistent with IPF prior to screening (based on the American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) consensus criteria for the diagnosis of IPF).

2. Forced (expiratory) Vital Capacity (FVC) ≥ 50% of predicted value.

3. DLco (corrected for hemoglobin) ≥ 30% predicted value.

4. Oxygen saturation > 90% at rest by pulse oximetry while breathing ambient air or receiving ≤2 L/minute of supplemental oxygen.

5. Residual volume ≤ 120% predicted value.

6. Ratio of Forced Expiratory Volume over 1 second (FEV1) to FVC ≥ 0.65 after the use of a bronchodilator.

7. Other known causes of interstitial lung disease have been excluded (e.g., drug toxicities, environmental exposures, connective tissue diseases).

8. High Resolution Computed Tomography (HRCT) image fulfills the criteria for 'Usual Interstitial Pneumonia (UIP) pattern'.

9. If the HRCT image does not fulfill the criteria for 'UIP pattern' a surgical lung biopsy is necessary for the diagnosis of IPF (lung biopsy performed prior to screening is acceptable). If a lung biopsy has been performed, it must fulfill the histopathological criteria for either 'UIP pattern' or 'probable UIP pattern' with the appropriate HRCT correlate.

10. Adequate bone marrow and liver function.

11. Patient has a life expectancy of at least 12 months.

Exclusion Criteria

1. Findings that are diagnostic of a condition other than UIP on surgical lung biopsy (performed either before or after screening), HRCT imaging, transbronchial lung biopsy, or bronchoalveolar lavage (BAL).

2. Serious local infection or systemic infection within 3 months prior to screening.

3. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 4 weeks of initial screening.

4. Currently receiving high dose corticosteroid, cytotoxic therapy (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), nintedanib (Ofev®), vasodilator therapy for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapy for IPF or administration of such therapeutics within 5 half-lives of the agent prior to initial screening in this study.

5. End-stage fibrotic disease requiring organ transplantation within 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

San Francisco, California, United States

Research Site

Atlanta, Georgia, United States

Research Site

Kansas City, Kansas, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

Lebanon, New Hampshire, United States

Research Site

Cleveland, Ohio, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Nashville, Tennessee, United States

Research Site

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

STX-003

Identifier Type: OTHER

Identifier Source: secondary_id

203PF201

Identifier Type: -

Identifier Source: org_study_id