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

NCT01371305 | Completed Phase 2 Results DMC

• 2 other identifiers: 203PF201STX-003
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 10

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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  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.

  up to Week 19

Secondary Outcomes (11)

• 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

Study Arms (2)

BG00011

EXPERIMENTAL

Participants will receive 8 consecutive weekly doses of BG00011

Drug: BG00011

Placebo

PLACEBO COMPARATOR

Participants will receive 8 consecutive weekly doses of placebo.

Drug: Placebo

Interventions

BG00011 DRUG

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

Also known as: STX-100

BG00011

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (10)

Research Site

San Francisco, California, 94143, United States

Location

Research Site

Atlanta, Georgia, 30322, United States

Location

Research Site

Kansas City, Kansas, 66160, United States

Location

Research Site

Boston, Massachusetts, 02114, United States

Location

Research Site

Boston, Massachusetts, 02115, United States

Location

Research Site

Lebanon, New Hampshire, 03756, United States

Location

Research Site

Cleveland, Ohio, 44195, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Research Site

Nashville, Tennessee, 37232, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Biogen Study Medical Director
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 10, 2011
• Study Start: July 16, 2012
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-02

Locations

US (10)