TriangleNCT04145531 · OUTCOME
Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 30 days (ADA- samples) after last dose of last course and up to 6 months (ADA+ samples) after last dose of last course, up to approximately 2 years 7 months
What was measured
Blood samples were collected for immunogenicity analysis. Anti-drug antibody positive (ADA+) participants were those with a positive result on the first test and also a positive result on the confirmatory test. Anti-drug antibody negative (ADA-) participants had a negative result on the first test.
Analysis population: Immunogenicity was assessed in the Safety Analysis Set.
Groups in this outcome
Part A: JZP-458 IM 25 mg/m^2 (MWF)
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
| Group | Source count |
|---|---|
| Part A: JZP-458 IM 25 mg/m^2 (MWF) | 33 |
| Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 83 |
| Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 51 |
| Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 61 |
Reported measurements
Overall confirmed ADA+
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: JZP-458 IM 25 mg/m^2 (MWF) | 16 | Not reported | Not reported | Not reported | Not reported |
| Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 41 | Not reported | Not reported | Not reported | Not reported |
| Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 25 | Not reported | Not reported | Not reported | Not reported |
| Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 34 | Not reported | Not reported | Not reported | Not reported |
Overall ADA-
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: JZP-458 IM 25 mg/m^2 (MWF) | 17 | Not reported | Not reported | Not reported | Not reported |
| Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 42 | Not reported | Not reported | Not reported | Not reported |
| Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 26 | Not reported | Not reported | Not reported | Not reported |
| Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 27 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 34
- title
- Overall confirmed ADA+
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 26
- group Id
- OG003
- value
- 27
- title
- Overall ADA-
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 51
- group Id
- OG003
- value
- 61
- units
- Participants
- description
- Blood samples were collected for immunogenicity analysis. Anti-drug antibody positive (ADA+) participants were those with a positive result on the first test and also a positive result on the confirmatory test. Anti-drug antibody negative (ADA-) participants had a negative result on the first test.
- groups
- description
- Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
- id
- OG000
- title
- Part A: JZP-458 IM 25 mg/m^2 (MWF)
- description
- Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
- id
- OG001
- title
- Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
- description
- Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
- id
- OG002
- title
- Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
- description
- Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
- id
- OG003
- title
- Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Immunogenicity was assessed in the Safety Analysis Set.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days (ADA- samples) after last dose of last course and up to 6 months (ADA+ samples) after last dose of last course, up to approximately 2 years 7 months
- title
- Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice