Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Biogen1 site in 1 country41 target enrollmentJuly 16, 2012

ConditionsIdiopathic Pulmonary Fibrosis (IPF)

InterventionsBG00011 Placebo

DrugsBG00011 Placebo

Overview

Phase: Phase 2
Intervention: BG00011
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Sponsor: Biogen
Enrollment: 41
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events (AEs)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 16, 2012

End Date

March 31, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).
•Forced (expiratory) Vital Capacity (FVC) ≥ 50% of predicted value.
•DLco (corrected for hemoglobin) ≥ 30% predicted value.
•Oxygen saturation \> 90% at rest by pulse oximetry while breathing ambient air or receiving ≤2 L/minute of supplemental oxygen.
•Residual volume ≤ 120% predicted value.
•Ratio of Forced Expiratory Volume over 1 second (FEV1) to FVC ≥ 0.65 after the use of a bronchodilator.
•Other known causes of interstitial lung disease have been excluded (e.g., drug toxicities, environmental exposures, connective tissue diseases).
•High Resolution Computed Tomography (HRCT) image fulfills the criteria for 'Usual Interstitial Pneumonia (UIP) pattern'.
•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.
•Adequate bone marrow and liver function.

Exclusion Criteria

•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).
•Serious local infection or systemic infection within 3 months prior to screening.
•Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 4 weeks of initial screening.
•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.
•End-stage fibrotic disease requiring organ transplantation within 6 months
•NOTE: Other protocol defined Inclusion/Exclusion Criteria may apply.

Arms & Interventions

BG00011

Participants will receive 8 consecutive weekly doses of BG00011

Intervention: BG00011

Placebo

Participants will receive 8 consecutive weekly doses of placebo.

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

Time Frame: up to Week 19

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.

Secondary Outcomes

Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011(Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Maximum Observed Serum Concentration (Cmax) of BG00011(Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011(Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011(Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Apparent Terminal Elimination Half Life (T1/2) of BG00011(Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Apparent Terminal Rate Constant [λz](Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011(Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Apparent Clearance (CL/F) of BG00011(Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Apparent Volume of Distribution (Vd/F) of BG00011(Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50)
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)(Baseline, Day 8 (Follow up))
Number of Participants With Treatment Emergent Antibodies to BG00011(Up to Week 19)