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

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ClinicalTrials.gov Identifier: NCT01371305
Recruitment Status : Completed
First Posted : June 10, 2011
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis (IPF)
Interventions Drug: BG00011
Drug: Placebo
Enrollment 41
Recruitment Details The participants were enrolled across 10 sites in the US.
Pre-assignment Details Forty-one participants were randomized and received at least one dose in the study.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo
Hide Arm/Group Description Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
Period Title: Overall Study
Started 6 6 6 7 6 10
Completed 6 6 6 5 2 8
Not Completed 0 0 0 2 4 2
Reason Not Completed
Adverse Event             0             0             0             2             1             0
Study terminated by sponsor             0             0             0             0             3             1
Subject request             0             0             0             0             0             1
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo Total
Hide Arm/Group Description Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 7 6 10 41
Hide Baseline Analysis Population Description
Safety population: The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 10 participants 41 participants
68  (2.7) 68  (5.9) 65  (9.6) 70  (4.0) 72  (9.7) 72  (7.4) 69  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 10 participants 41 participants
Female
2
  33.3%
0
   0.0%
1
  16.7%
0
   0.0%
2
  33.3%
1
  10.0%
6
  14.6%
Male
4
  66.7%
6
 100.0%
5
  83.3%
7
 100.0%
4
  66.7%
9
  90.0%
35
  85.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 10 participants 41 participants
White
6
 100.0%
6
 100.0%
6
 100.0%
7
 100.0%
6
 100.0%
10
 100.0%
41
 100.0%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
6
 100.0%
7
 100.0%
6
 100.0%
10
 100.0%
41
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame up to Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6 10
Measure Type: Number
Unit of Measure: Participants
6 5 6 4 6 7
2.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population = Safety population.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: hours
Day 1 Number Analyzed 2 participants 5 participants 6 participants 7 participants 6 participants
168 [1]   (NA) 101  (42.9) 132  (39.4) 134  (60.5) 96.4  (53.5)
Day 50 Number Analyzed 6 participants 6 participants 6 participants 6 participants 4 participants
42.7  (61.9) 64.0  (24.8) 64.0  (51.8) 32.0  (19.6) 38.0  (39.4)
[1]
Insufficient data to perform analysis.
3.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of BG00011
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population = Safety population.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Day 1 Number Analyzed 2 participants 5 participants 6 participants 7 participants 6 participants
71.3 [1]   (NA) 335  (178) 716  (281) 4370  (1350) 12900  (3130)
Day 50 Number Analyzed 6 participants 6 participants 6 participants 6 participants 4 participants
134  (44.6) 1080  (676) 3170  (1380) 15400  (5180) 52800  (17600)
[1]
Insufficient data to perform analysis.
4.Secondary Outcome
Title Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population = Safety population.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: hours nanogram per milliliter (hr*ng/mL)
Day 1 Number Analyzed 2 participants 5 participants 6 participants 7 participants 6 participants
9200 [1]   (NA) 44800  (24800) 92600  (40500) 513000  (264000) 1730000  (525000)
Day 50 Number Analyzed 6 participants 6 participants 6 participants 6 participants 4 participants
44600  (39400) 344000  (169000) 1080000  (554000) 6370000  (3980000) 25700000  (17700000)
[1]
Insufficient data to perform analysis.
5.Secondary Outcome
Title Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population = Safety population.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
Day 1 Number Analyzed 2 participants 5 participants 6 participants 6 participants 5 participants
9200 [1]   (NA) 44800  (24800) 92600  (40500) 497000  (242000) 1690000  (438000)
Day 50 Number Analyzed 5 participants 6 participants 6 participants 6 participants 4 participants
21000  (8250) 159000  (91200) 465000  (209000) 2290000  (769000) 8310000  (2840000)
[1]
Insufficient data to perform analysis.
6.Secondary Outcome
Title Apparent Terminal Elimination Half Life (T1/2) of BG00011
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population = Safety population. Data for this outcome measure was not collected at Day 1.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: hour
Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Day 50 Number Analyzed 1 participants 6 participants 6 participants 5 participants 2 participants
178 [1]   (NA) 177  (123) 168  (56.8) 178  (60.9) 250 [1]   (NA)
[1]
Insufficient data to perform analysis.
7.Secondary Outcome
Title Apparent Terminal Rate Constant [λz]
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population = Safety population. Data for this outcome measure was not collected at Day 1.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: hour
Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Day 50 Number Analyzed 1 participants 6 participants 6 participants 5 participants 2 participants
0.00390 [1]   (NA) 0.00508  (0.00226) 0.00442  (0.00112) 0.00423  (0.00123) 0.00286 [1]   (NA)
[1]
Insufficient data to perform analysis.
8.Secondary Outcome
Title Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population = Safety population. Data for this outcome measure was not collected at Day 1.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Day 50 Number Analyzed 1 participants 6 participants 6 participants 5 participants 2 participants
41900 [1]   (NA) 362000  (173000) 1190000  (690000) 7250000  (4230000) 24300000 [1]   (NA)
[1]
Insufficient data to perform analysis.
9.Secondary Outcome
Title Apparent Clearance (CL/F) of BG00011
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population = Safety population. Data for this outcome measure was not collected at Day 1.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: milliliter/hour/kilogram (mL/hr/kg)
Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Day 50 Number Analyzed 1 participants 6 participants 6 participants 5 participants 2 participants
0.913 [1]   (NA) 0.758  (0.290) 0.801  (0.441) 0.501  (0.172) 0.486 [1]   (NA)
[1]
Insufficient data to perform analysis.
10.Secondary Outcome
Title Apparent Volume of Distribution (Vd/F) of BG00011
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population = safety population. Data for this outcome measure was not analysed on day 1.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: milliliter per kilogram (mL/kg)
Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Day 50 Number Analyzed 1 participants 6 participants 6 participants 5 participants 2 participants
234 [1]   (NA) 183  (96.0) 183  (88.0) 120  (29.8) 168 [1]   (NA)
[1]
Insufficient data to perform analysis.
11.Secondary Outcome
Title Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
Hide Description 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.
Time Frame Baseline, Day 8 (Follow up)
Hide Outcome Measure Data
Hide Analysis Population Description
The "Pharmacodynamic" population consisted of all participants who received at least 1 multiple dose injection of BG00011 and have a corresponding sample collected for BAL and/or blood biomarkers.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received matching placebo.
Overall Number of Participants Analyzed 6 6 6 7 4 10
Mean (Standard Deviation)
Unit of Measure: Percentage
ALOX5; PC at Day 8 (Follow Up) Number Analyzed 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants
4.39  (16.560) -0.25  (11.154) -5.16  (23.074) -51.07  (22.942) -70.90  (14.633) -7.87  (15.793)
FN1; PC at Day 8 (Follow Up) Number Analyzed 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants
0.42  (20.776) -4.83  (22.035) -16.84  (15.424) -65.41  (16.174) -77.42  (17.989) -8.27  (23.881)
OLR1; PC at Day 8 (Follow Up) Number Analyzed 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants
-4.79  (31.104) -1.58  (16.207) -15.09  (25.235) -63.64  (18.657) -77.97  (14.602) -3.56  (21.215)
PAI-1; aka SERPINE 1; PC at Day 8 (Follow Up) Number Analyzed 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants
26.98  (55.559) -28.27  (10.055) 7.83  (30.064) -26.06  (38.247) 71.44  (115.042) -1.40  (59.537)
TGM2; PC at Day 8 (Follow Up) Number Analyzed 6 participants 6 participants 6 participants 6 participants 4 participants 9 participants
0.71  (31.009) -3.06  (41.757) -13.17  (35.547) -53.15  (28.412) -71.35  (17.449) 15.06  (59.874)
TREM1; PC at Day 8 (Follow Up) Number Analyzed 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants
-3.71  (20.135) -2.01  (16.654) -7.66  (21.151) -48.33  (23.511) -63.13  (13.700) -12.83  (17.397)
ETS1; PC at Day 8 (Follow Up) Number Analyzed 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants
3.16  (53.425) -11.52  (26.342) -10.54  (43.866) 240.59  (245.766) 103.16  (152.301) 65.10  (146.690)
pSMAD2 to tSMAD2; PC at Day 8 (Follow Up) Number Analyzed 3 participants 4 participants 5 participants 5 participants 4 participants 7 participants
23.91  (54.293) -3.33  (29.724) -39.82  (24.675) -63.74  (34.674) -76.20  (14.834) 28.59  (52.270)
12.Secondary Outcome
Title Number of Participants With Treatment Emergent Antibodies to BG00011
Hide Description [Not Specified]
Time Frame Up to Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
Overall Number of Participants Analyzed 6 6 6 7 6 10
Measure Type: Number
Unit of Measure: participants
1 0 0 0 0 0
Time Frame Up to Week 19
Adverse Event Reporting Description

The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.

The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.

 
Arm/Group Title BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo
Hide Arm/Group Description Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses. Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
All-Cause Mortality
BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      1/7 (14.29%)      0/6 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/6 (0.00%)      0/6 (0.00%)      2/7 (28.57%)      1/6 (16.67%)      0/10 (0.00%)    
Cardiac disorders             
Atrioventricular Block Complete  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0
Type II Second-Degree Atrioventricular Block  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/10 (0.00%)  0
Injury, poisoning and procedural complications             
Jaw fracture  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders             
Syncope  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Hypoxia  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0
Idiopathic Pulmonary Fibrosis Exacerbation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/7 (28.57%)  2 0/6 (0.00%)  0 0/10 (0.00%)  0
Respiratory Failure  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA Version 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BG00011 0.015 mg BG00011 0.1 mg BG00011 0.3 mg BG00011 1.0 mg BG00011 3.0 mg Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      5/6 (83.33%)      6/6 (100.00%)      4/7 (57.14%)      6/6 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders             
Thrombocytopenia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/10 (10.00%) 
Anaemia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Cardiac disorders             
Angina Pectoris  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Atrioventricular Block Complete  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Atrioventricular Block Second Degree  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Bradycardia  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Endocrine disorders             
Hypothyroidism  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders             
Constipation  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Dyspepsia  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Abdominal Pain  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Cheilitis  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Sensitivity of Teeth  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Umbilical Hernia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
General disorders             
Injection Site Pain  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Fatigue  1  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  1/10 (10.00%) 
Chest Discomfort  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Chills  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Chest Pain  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Infusion Site Bruising  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Injection Site Erythema  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Injection Site Paraesthesia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Non-Cardiac Chest Pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Oedema Peripheral  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Pyrexia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Vessel Puncture Site Pain  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Immune system disorders             
Seasonal Allergy  1  0/6 (0.00%)  3/6 (50.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Infections and infestations             
Viral Infection  1  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Upper Respiratory Tract Infection  1  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  1/10 (10.00%) 
Bronchitis  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Acute Sinusitis  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Sinusitis  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Genital Herpes  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/10 (10.00%) 
Injury, poisoning and procedural complications             
Contusion  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  0/10 (0.00%) 
Bone Contusion  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Fall  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Jaw Fracture  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Laceration  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Ligament Sprain  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Limb Injury  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Muscle Strain  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Procedural Complication  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Procedural Pain  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Sunburn  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Tooth Fracture  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Eye Contusion  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/10 (10.00%) 
Investigations             
Hepatic Enzyme Increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Blood Lactate Dehydrogenase Increased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Blood Pressure Increased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Electrocardiogram Qt Prolonged  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Glucose Urine Present  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Oxygen Saturation Decreased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Protein Urine Present  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Total Lung Capacity Decreased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  1/10 (10.00%) 
Urine Analysis Abnormal  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Urine Leukocyte Esterase Positive  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Cardiac Murmur  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/10 (10.00%) 
Pulmonary Function Test Decreased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders             
Hyponatraemia  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Musculoskeletal Chest Pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  0/10 (0.00%) 
Myalgia  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Back Pain  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Bursitis  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Muscle Fatigue  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Musculoskeletal Pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Musculoskeletal Stiffness  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Pain in Extremity  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Squamous Cell Carcinoma of Skin  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/10 (10.00%) 
Nervous system disorders             
Dizziness  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/7 (14.29%)  1/6 (16.67%)  1/10 (10.00%) 
Headache  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Syncope  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  0/10 (0.00%) 
Migraine  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Psychiatric disorders             
Insomnia  1  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Anxiety  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Thinking Abnormal  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Idiopathic Pulmonary Fibrosis  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  3/6 (50.00%)  0/10 (0.00%) 
Cough  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  2/6 (33.33%)  1/10 (10.00%) 
Dyspnoea  1  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  1/10 (10.00%) 
Hypoxia  1  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  0/10 (0.00%) 
Viral Upper Respiratory Tract Infection  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/7 (28.57%)  0/6 (0.00%)  0/10 (0.00%) 
Oropharyngeal Pain  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Productive Cough  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Rhinitis Allergic  1  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Rhinorrhoea  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Upper-Airway Cough Syndrome  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Haemoptysis  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Increased Bronchial Secretion  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Lung Disorder  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Nasal Discharge Discoloration  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Respiratory Failure  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/10 (0.00%) 
Sinus Congestion  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Sleep Apnoea Syndrome  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/10 (0.00%) 
Sputum Discolored  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders             
Onychoclasis  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Rash  1  0/6 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Night Sweats  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Acne  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Skin Lesion  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
Vascular disorders             
Phlebitis Superficial  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/10 (10.00%) 
Hypotension  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Biogen Study Medical Director
Organization: Biogen
Phone: 866-633-4636
EMail: clinicaltrials@biogen.com
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01371305    
Other Study ID Numbers: 203PF201
STX-003 ( Other Identifier: Stromedix, Inc. )
First Submitted: June 3, 2011
First Posted: June 10, 2011
Results First Submitted: February 12, 2020
Results First Posted: February 28, 2020
Last Update Posted: February 28, 2020