Trial · NCT01371305
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT01371305, Phase 2, Completed, Biogen; results first posted 2020-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF). Trials, record NCT01371305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01371305
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- NCT number
- NCT01371305
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Interventions
- BG00011, Placebo
- First posted
- 2011-06-10
- Last updated
- 2020-02-28
- Results first posted
- 2020-02-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | up to Week 19 | The Safety population consisted of all participants who received at least one dose of BG00011 or placebo. | Participants | NUMBER |
| SECONDARY | 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 | Pharmacokinetic (PK) population = Safety population. | hours | MEAN |
| SECONDARY | 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 | PK population = Safety population. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | 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 | PK population = Safety population. | hours nanogram per milliliter (hr*ng/mL) | MEAN |
| SECONDARY | 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 | PK population = Safety population. | hr*ng/mL | MEAN |
| SECONDARY | 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 | PK population = Safety population. Data for this outcome measure was not collected at Day 1. | hour | MEAN |
| SECONDARY | 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 | PK population = Safety population. Data for this outcome measure was not collected at Day 1. | hour | MEAN |
| SECONDARY | 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 | PK population = Safety population. Data for this outcome measure was not collected at Day 1. | hr*ng/mL | MEAN |
| SECONDARY | 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 | PK population = Safety population. Data for this outcome measure was not collected at Day 1. | milliliter/hour/kilogram (mL/hr/kg) | MEAN |
| SECONDARY | 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 | PK population = safety population. Data for this outcome measure was not analysed on day 1. | milliliter per kilogram (mL/kg) | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | BG00011 0.015 mg | 6 | Participants | ||
| Number of Participants With Adverse Events (AEs) | BG00011 0.1 mg | 5 | Participants | ||
| Number of Participants With Adverse Events (AEs) | BG00011 0.3 mg | 6 | Participants | ||
| Number of Participants With Adverse Events (AEs) | BG00011 1.0 mg | 4 | Participants | ||
| Number of Participants With Adverse Events (AEs) | BG00011 3.0 mg | 6 | Participants | ||
| Number of Participants With Adverse Events (AEs) | Matching Placebo | 7 | Participants | ||
| Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011 | BG00011 0.015 mg | Day 1 | 168 | Standard Deviation NA | hours |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011 | BG00011 0.1 mg | Day 1 | 101 | Standard Deviation 42.9 | hours |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011 | BG00011 0.3 mg | Day 1 | 132 | Standard Deviation 39.4 | hours |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011 | BG00011 1.0 mg | Day 1 | 134 | Standard Deviation 60.5 | hours |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BG00011 0.015 mg | 6 | |
| Overall Study | STARTED | BG00011 0.1 mg | 6 | |
| Overall Study | STARTED | BG00011 0.3 mg | 6 | |
| Overall Study | STARTED | BG00011 1.0 mg | 7 | |
| Overall Study | STARTED | BG00011 3.0 mg | 6 | |
| Overall Study | STARTED | Matching Placebo | 10 | |
| Overall Study | COMPLETED | BG00011 0.015 mg | 6 | |
| Overall Study | COMPLETED | BG00011 0.1 mg | 6 | |
| Overall Study | COMPLETED | BG00011 0.3 mg | 6 | |
| Overall Study | COMPLETED | BG00011 1.0 mg | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events642
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection Site Pain | General disorders | BG00011 0.015 mg | 0 | 6 | |
| other | Injection Site Pain | General disorders | BG00011 0.1 mg | 1 | 6 | |
| other | Injection Site Pain | General disorders | BG00011 0.3 mg | 1 | 6 | |
| other | Injection Site Pain | General disorders | BG00011 1.0 mg | 0 | 7 | |
| other | Injection Site Pain | General disorders | BG00011 3.0 mg | 1 | 6 | |
| other | Injection Site Pain | General disorders | Matching Placebo | 0 | 10 | |
| other | Viral Infection | Infections and infestations | BG00011 0.015 mg | 2 | 6 | |
| other | Viral Infection | Infections and infestations | BG00011 0.1 mg | 0 | 6 | |
| other | Viral Infection | Infections and infestations | BG00011 0.3 mg | 0 | 6 | |
| other | Viral Infection | Infections and infestations | BG00011 1.0 mg | 0 | 7 |
1 to 10 of 642Source ClinicalTrials.gov
See all 642 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BG00011 0.015 mg | 0 | 6 |
| Total, all-cause mortality | BG00011 0.1 mg | 0 | 6 |
| Total, all-cause mortality | BG00011 0.3 mg | 0 | 6 |
| Total, all-cause mortality | BG00011 1.0 mg | 1 | 7 |
| Total, all-cause mortality | BG00011 3.0 mg | 0 | 6 |
| Total, all-cause mortality | Matching Placebo | 0 | 10 |
| Total, other adverse events | BG00011 0.015 mg | 6 | 6 |
| Total, other adverse events | BG00011 0.1 mg | 5 | 6 |
| Total, other adverse events | BG00011 0.3 mg | 6 | 6 |
| Total, other adverse events | BG00011 1.0 mg | 4 | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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