Trial Outcomes & Findings for A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants (NCT NCT02093923)
NCT ID: NCT02093923
Last Updated: 2021-05-27
Results Overview
A SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes: Death, Life-threatening experience, required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant disability or incapacity. Was a congenital anomaly or birth defect. Was considered to be an important medical event. An AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
From Day 1 up to final follow-up (Day 123)
Results posted on
2021-05-27
Participant Flow
Participants were recruited in United States, Italy, and Jordan between 14 May 2014 (first participant first visit) and 18 May 2015 (last participant last visit).
A total of 38 participants were randomized and 37 participants were treated out of them 36 participants completed the study.
Participant milestones
| Measure |
DX-2930, Cohort 1
Participants received 30 milligram (mg) dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
12
|
13
|
|
Overall Study
Total Treated
|
4
|
4
|
5
|
11
|
13
|
|
Overall Study
Treated - 1 Dose Only:
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Treated - 2 Doses:
|
4
|
4
|
5
|
10
|
13
|
|
Overall Study
COMPLETED
|
4
|
4
|
5
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
DX-2930, Cohort 1
Participants received 30 milligram (mg) dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Screen failure after randomization
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
Baseline characteristics by cohort
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=11 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
n=13 Participants
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
|
Age, Customized
>65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to final follow-up (Day 123)Population: Safety Population included all randomized participants who received at least 1 dose of study drug.
A SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes: Death, Life-threatening experience, required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant disability or incapacity. Was a congenital anomaly or birth defect. Was considered to be an important medical event. An AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=11 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
n=13 Participants
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE)
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE)
Treatment Emergent Adverse Events
|
1 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120Population: Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile.
Pharmacokinetic (PK) parameter Cmax data were reported.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=9 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
3895.0 Nanogram per milliliter (ng/mL)
Standard Deviation 2159.76
|
7890.0 Nanogram per milliliter (ng/mL)
Standard Deviation 2058.43
|
27460.0 Nanogram per milliliter (ng/mL)
Standard Deviation 14542.46
|
45322.2 Nanogram per milliliter (ng/mL)
Standard Deviation 8704.56
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120Population: Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile.
PK parameter Tmax data were reported.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=9 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
17.930 Days
Standard Deviation 1.1400
|
18.020 Days
Standard Deviation 0.4596
|
18.172 Days
Standard Deviation 1.4526
|
17.700 Days
Standard Deviation 0.9804
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120Population: Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile.
PK paramenter AUC data were reported.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=9 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve (AUC)
|
64100.0 day*nanogram per milliliter (day*ng/mL)
Standard Deviation 34731.16
|
135425.0 day*nanogram per milliliter (day*ng/mL)
Standard Deviation 48616.76
|
451800.0 day*nanogram per milliliter (day*ng/mL)
Standard Deviation 226801.01
|
762777.8 day*nanogram per milliliter (day*ng/mL)
Standard Deviation 166713.66
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120Population: Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile.
PK parameter CL/F data were reported.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=9 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F)
|
0.5720 Liter per day (L/day)
Standard Deviation 0.26829
|
0.8110 Liter per day (L/day)
Standard Deviation 0.28258
|
1.0036 Liter per day (L/day)
Standard Deviation 0.90870
|
0.5514 Liter per day (L/day)
Standard Deviation 0.14318
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120Population: Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile.
PK parameter Vd/F data were reported.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=9 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F)
|
11.553 Liter (L)
Standard Deviation 4.9218
|
16.125 Liter (L)
Standard Deviation 2.6949
|
17.436 Liter (L)
Standard Deviation 10.5609
|
11.696 Liter (L)
Standard Deviation 2.7600
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120Population: Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile.
PK parameter t(1/2) data were reported.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=9 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2)
|
14.225 Day
Standard Deviation 0.8261
|
14.625 Day
Standard Deviation 3.4082
|
13.802 Day
Standard Deviation 3.2535
|
14.967 Day
Standard Deviation 2.4377
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8 to Day 50Population: All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment.
Analysis of this outcome measure was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the pre-specified assessment period (Days 8 to 50; predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week was a covariate, treatment group is a fixed effect, and participant was a random effect in the GEE model with independence working correlation structure.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=11 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=15 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=11 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
HAE Attack Rate Per Week From Day 8 to Day 50
Mean baseline HAE attack rate (attacks/week)
|
0.3269 HAE attacks per week
Standard Error 0.24627
|
0.5455 HAE attacks per week
Standard Error 0.17356
|
0.4872 HAE attacks per week
Standard Error 0.21100
|
0.3916 HAE attacks per week
Standard Error 0.17694
|
—
|
|
HAE Attack Rate Per Week From Day 8 to Day 50
Mean HAE attack rate, unadjusted (attacks/week)
|
0 HAE attacks per week
Standard Error NA
No attacks were reported for this arm/group.
|
0.0476 HAE attacks per week
Standard Error 0.15040
|
0.0345 HAE attacks per week
Standard Error 0.12894
|
0.3636 HAE attacks per week
Standard Error 0.36376
|
—
|
|
HAE Attack Rate Per Week From Day 8 to Day 50
Estimated mean rate based on GEE (attacks/week)
|
0 HAE attacks per week
Standard Error NA
No attacks were reported for this arm/group.
|
0.0454 HAE attacks per week
Standard Error 0.03319
|
0.0333 HAE attacks per week
Standard Error 0.02404
|
0.3712 HAE attacks per week
Standard Error 0.09596
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8 to Day 92Population: All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment.
This endpoint analysis was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Day 8 to Day 92 predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and participant is a random effect in the GEE model with independence working correlation structure.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=11 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=15 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=11 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
HAE Attacks Per Week From Day 8 to Day 92
Mean baseline HAE attack rate (attacks/week)
|
0.3269 HAE Attacks per Week
Standard Deviation 0.24627
|
0.5455 HAE Attacks per Week
Standard Deviation 0.17356
|
0.4872 HAE Attacks per Week
Standard Deviation 0.21100
|
0.3916 HAE Attacks per Week
Standard Deviation 0.17694
|
—
|
|
HAE Attacks Per Week From Day 8 to Day 92
Mean HAE attack rate, unadjusted (attacks/week)
|
0 HAE Attacks per Week
Standard Deviation NA
No attacks were reported for this arm/group.
|
0.0732 HAE Attacks per Week
Standard Deviation 0.12665
|
0.0526 HAE Attacks per Week
Standard Deviation 0.11206
|
0.3636 HAE Attacks per Week
Standard Deviation 0.36945
|
—
|
|
HAE Attacks Per Week From Day 8 to Day 92
Estimated mean rate based on GEE (attacks/week)
|
0 HAE Attacks per Week
Standard Deviation NA
No attacks were reported for this arm/group.
|
0.0603 HAE Attacks per Week
Standard Deviation 0.02438
|
0.0461 HAE Attacks per Week
Standard Deviation 0.01826
|
0.3787 HAE Attacks per Week
Standard Deviation 0.10957
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8 to Day 64Population: All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment.
This endpoint analysis was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Day 8 to Day 64 predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and participant is a random effect in the GEE model with independence working correlation structure.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=11 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=15 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=11 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
HAE Attacks Per Week From Day 8 to Day 64
Mean baseline HAE attack rate
|
0.3269 HAE Attacks per Week
Standard Deviation 0.24627
|
0.5455 HAE Attacks per Week
Standard Deviation 0.17356
|
0.4872 HAE Attacks per Week
Standard Deviation 0.21100
|
0.3916 HAE Attacks per Week
Standard Deviation 0.17694
|
—
|
|
HAE Attacks Per Week From Day 8 to Day 64
Mean HAE attack rate, unadjusted
|
0 HAE Attacks per Week
Standard Deviation NA
No attacks were reported for this arm/group.
|
0.0723 HAE Attacks per Week
Standard Deviation 0.13227
|
0.0522 HAE Attacks per Week
Standard Deviation 0.11651
|
0.3636 HAE Attacks per Week
Standard Deviation 0.33752
|
—
|
|
HAE Attacks Per Week From Day 8 to Day 64
Estimated mean rate based on GEE
|
0 HAE Attacks per Week
Standard Deviation NA
No attacks were reported for this arm/group.
|
0.0661 HAE Attacks per Week
Standard Deviation 0.02759
|
0.0490 HAE Attacks per Week
Standard Deviation 0.02002
|
0.3773 HAE Attacks per Week
Standard Deviation 0.09518
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 50Population: All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment.
This endpoint analysis was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Day 1 to Day 50 predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and participant is a random effect in the GEE model with independence working correlation structure.
Outcome measures
| Measure |
DX-2930, Cohort 1
n=4 Participants
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=11 Participants
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=15 Participants
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=11 Participants
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
HAE Attack Rate Per Week From Day 1 to Day 50
Mean baseline HAE attack rate (attacks/week)
|
0.3269 HAE attacks per week
Standard Deviation 0.24627
|
0.5455 HAE attacks per week
Standard Deviation 0.17356
|
0.4872 HAE attacks per week
Standard Deviation 0.21100
|
0.3916 HAE attacks per week
Standard Deviation 0.17694
|
—
|
|
HAE Attack Rate Per Week From Day 1 to Day 50
Mean HAE attack rate, unadjusted (attacks/week)
|
0 HAE attacks per week
Standard Deviation NA
No attacks were reported for this arm/group
|
0.0541 HAE attacks per week
Standard Deviation 0.17634
|
0.0392 HAE attacks per week
Standard Deviation 0.15105
|
0.3506 HAE attacks per week
Standard Deviation 0.32803
|
—
|
|
HAE Attack Rate Per Week From Day 1 to Day 50
Estimated mean rate based on GEE (attacks/week)
|
0 HAE attacks per week
Standard Deviation NA
No attacks were reported for this arm/group.
|
0.0525 HAE attacks per week
Standard Deviation 0.03998
|
0.0382 HAE attacks per week
Standard Deviation 0.02898
|
0.3588 HAE attacks per week
Standard Deviation 0.08864
|
—
|
Adverse Events
DX-2930, Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DX-2930, Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DX-2930, Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DX-2930, Cohort 4
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DX-2930, Cohort 1
n=4 participants at risk
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 participants at risk
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 participants at risk
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=11 participants at risk
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
n=13 participants at risk
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
7.7%
1/13 • Number of events 1 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
Other adverse events
| Measure |
DX-2930, Cohort 1
n=4 participants at risk
Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 2
n=4 participants at risk
Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 3
n=5 participants at risk
Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
DX-2930, Cohort 4
n=11 participants at risk
Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
Placebo
n=13 participants at risk
Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
|
|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Hereditary Angioedema
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
75.0%
3/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
20.0%
1/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
45.5%
5/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
69.2%
9/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
9.1%
1/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
7.7%
1/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
25.0%
1/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
20.0%
1/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
25.0%
1/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
20.0%
1/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
9.1%
1/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
20.0%
1/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
9.1%
1/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
25.0%
1/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
20.0%
1/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
7.7%
1/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
9.1%
1/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
15.4%
2/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
General disorders
Injection Site Pain
|
25.0%
1/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
50.0%
2/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
27.3%
3/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
23.1%
3/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
18.2%
2/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Infections and infestations
Infleunza
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
20.0%
1/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
7.7%
1/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
25.0%
1/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
7.7%
1/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
9.1%
1/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
7.7%
1/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
18.2%
2/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
25.0%
1/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
7.7%
1/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
20.0%
1/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
0.00%
0/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
7.7%
1/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
50.0%
2/4 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
20.0%
1/5 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
9.1%
1/11 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
23.1%
3/13 • From Day 1 up to final follow-up (Day 123)
A participant who experienced multiple events within a preferred term was counted once within that preferred term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Dyax agreements vary, but Dyax will not prohibit any investigator from publishing. Dyax reviews publications prior to public release and can request deferral by up to 60 days beyond the proposed publication date if necessary to preserve its intellectual property. Dyax can request changes to publications to remove non-study-related confidential information. Dyax can also request deferral of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER