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Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT01371305

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

A Phase 2 study testing BG00011 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Biogen at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis (IPF)
What is being tested?
BG00011
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
10 sitesUnited States
Study dates
16 Jul 2012to 31 Mar 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Research Site

    Atlanta, Georgia, 30322

  • Research Site

    Boston, Massachusetts, 02114

  • Research Site

    Boston, Massachusetts, 02115

  • Research Site

    Cleveland, Ohio, 44195

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Kansas City, Kansas, 66160

  • Research Site

    Lebanon, New Hampshire, 03756

  • Research Site

    Nashville, Tennessee, 37232

  • Research Site

    Pittsburgh, Pennsylvania, 15213

  • Research Site

    San Francisco, California, 94143

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
BG00011, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BG00011Drug

    Also called STX-100

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

  • PlaceboDrug

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

Study groups in NCT01371305
Study groupRoleWhat they receive
BG00011ExperimentalParticipants will receive 8 consecutive weekly doses of BG00011
Receives: Drug: BG00011
PlaceboPlacebo comparatorParticipants will receive 8 consecutive weekly doses of placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to Week 19

Secondary outcomes (11)

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

    Measured: 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

  2. Maximum Observed Serum Concentration (Cmax) of BG00011

    Measured: 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

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

    Measured: 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

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

    Measured: 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

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

    Measured: 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

  6. Apparent Terminal Rate Constant [λz]

    Measured: 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

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

    Measured: 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

  8. Apparent Clearance (CL/F) of BG00011

    Measured: 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

  9. Apparent Volume of Distribution (Vd/F) of BG00011

    Measured: 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

  10. 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.

    Measured: Baseline, Day 8 (Follow up)

  11. Number of Participants With Treatment Emergent Antibodies to BG00011

    Measured: Up to Week 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2011 (estimated)
  2. Study start16 Jul 2012
  3. Primary completion31 Mar 2017
  4. Study completion31 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01371305
Sponsor's protocol ID
203PF201
Other IDs
STX-003
Status last verified
Feb 2020
First submitted
3 Jun 2011
Last updated
28 Feb 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BG00011 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Biogen at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: up to Week 19). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01371305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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