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

Primary Purpose

Idiopathic Pulmonary Fibrosis (IPF)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BG00011

Placebo

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Key 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 of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BG00011

Placebo

Arm Description

Participants will receive 8 consecutive weekly doses of BG00011

Participants will receive 8 consecutive weekly doses of placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011

Maximum Observed Serum Concentration (Cmax) of BG00011

Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011

Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011

Apparent Terminal Elimination Half Life (T1/2) of BG00011

Apparent Terminal Rate Constant [λz]

Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011

Apparent Clearance (CL/F) of BG00011

Apparent Volume of Distribution (Vd/F) of BG00011

Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)

The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels.

Number of Participants With Treatment Emergent Antibodies to BG00011

Full Information

NCT ID

NCT01371305

First Posted

June 3, 2011

Last Updated

February 12, 2020

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT01371305

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

July 16, 2012 (Actual)

Primary Completion Date

March 31, 2017 (Actual)

Study Completion Date

March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Fibrosis (IPF)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BG00011

Arm Type

Experimental

Arm Description

Participants will receive 8 consecutive weekly doses of BG00011

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive 8 consecutive weekly doses of placebo.

Intervention Type

Drug

Intervention Name(s)

BG00011

Other Intervention Name(s)

STX-100

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

up to Week 19

Secondary Outcome Measure Information:

Title

Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011

Time Frame