TriangleNCT03340883 · OUTCOME
Biomarkers (Phase 1 and 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- % change relative to baseline
- Interval / dispersion
- Full Range
- Time frame
- Baseline and approximately 2 years
What was measured
Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)
Analysis population: Study was terminated early and Phase 2 did not enroll. BCMA was an exploratory endpoint and was not reported.
Groups in this outcome
BION-1301 50 mg Q2W
50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
BION-1301 150 mg Q2W
150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
BION-1301 450 mg Q2W
450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
BION-1301 1350 mg Q2W
1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
BION-1301 2700 mg Q2W
2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
BION-1301 1350 mg QW*8W->Q2W
1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
| Group | Source count |
|---|---|
| BION-1301 50 mg Q2W | 4 |
| BION-1301 150 mg Q2W | 3 |
| BION-1301 450 mg Q2W | 4 |
| BION-1301 1350 mg Q2W | 4 |
| BION-1301 2700 mg Q2W | 3 |
| BION-1301 1350 mg QW*8W->Q2W | 3 |
Reported measurements
Free APRIL target engagement (AUEC1-15d)
| Group | Source count |
|---|---|
| BION-1301 50 mg Q2W | 4 |
| BION-1301 150 mg Q2W | 3 |
| BION-1301 450 mg Q2W | 4 |
| BION-1301 1350 mg Q2W | 4 |
| BION-1301 2700 mg Q2W | 3 |
| BION-1301 1350 mg QW*8W->Q2W | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BION-1301 50 mg Q2W | 1000 | Not reported | 580 | 1500 | Not reported |
| BION-1301 150 mg Q2W | 970 | Not reported | 750 | 1200 | Not reported |
| BION-1301 450 mg Q2W | 470 | Not reported | 190 | 620 | Not reported |
| BION-1301 1350 mg Q2W | 140 | Not reported | 79 | 510 | Not reported |
| BION-1301 2700 mg Q2W | 72 | Not reported | 70 | 250 | Not reported |
| BION-1301 1350 mg QW*8W->Q2W | 200 | Not reported | 56 | 240 | Not reported |
BCMA
| Group | Source count |
|---|---|
| BION-1301 50 mg Q2W | 0 |
| BION-1301 150 mg Q2W | 0 |
| BION-1301 450 mg Q2W | 0 |
| BION-1301 1350 mg Q2W | 0 |
| BION-1301 2700 mg Q2W | 0 |
| BION-1301 1350 mg QW*8W->Q2W | 0 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 580
- upper Limit
- 1500
- value
- 1000
- group Id
- OG001
- lower Limit
- 750
- upper Limit
- 1200
- value
- 970
- group Id
- OG002
- lower Limit
- 190
- upper Limit
- 620
- value
- 470
- group Id
- OG003
- lower Limit
- 79
- upper Limit
- 510
- value
- 140
- group Id
- OG004
- lower Limit
- 70
- upper Limit
- 250
- value
- 72
- group Id
- OG005
- lower Limit
- 56
- upper Limit
- 240
- value
- 200
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- units
- Participants
- title
- Free APRIL target engagement (AUEC1-15d)
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- BCMA
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)
- dispersion Type
- Full Range
- groups
- description
- 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
- id
- OG000
- title
- BION-1301 50 mg Q2W
- description
- 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
- id
- OG001
- title
- BION-1301 150 mg Q2W
- description
- 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
- id
- OG002
- title
- BION-1301 450 mg Q2W
- description
- 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
- id
- OG003
- title
- BION-1301 1350 mg Q2W
- description
- 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
- id
- OG004
- title
- BION-1301 2700 mg Q2W
- description
- 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
- id
- OG005
- title
- BION-1301 1350 mg QW*8W->Q2W
- param Type
- MEDIAN
- population Description
- Study was terminated early and Phase 2 did not enroll. BCMA was an exploratory endpoint and was not reported.
- reporting Status
- POSTED
- time Frame
- Baseline and approximately 2 years
- title
- Biomarkers (Phase 1 and 2)
- type
- PRIMARY
- unit Of Measure
- % change relative to baseline
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice