Trial Outcomes & Findings for A Study of Two Formulations of Ixekizumab in Healthy Participants (NCT NCT04259346)
NCT ID: NCT04259346
Last Updated: 2022-04-08
Results Overview
PK: Cmax of ixekizumab was evaluated
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
245 participants
Primary outcome timeframe
Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose
Results posted on
2022-04-08
Participant Flow
Participant milestones
| Measure |
80 Milligram (mg) Ixekizumab (Reference)
Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a subcutaneous (SC) injection via autoinjector (AI).
|
80 mg Ixekizumab (Test)
Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
119
|
|
Overall Study
Received at Least One Dose of Study Drug
|
126
|
119
|
|
Overall Study
COMPLETED
|
122
|
115
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
80 Milligram (mg) Ixekizumab (Reference)
Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a subcutaneous (SC) injection via autoinjector (AI).
|
80 mg Ixekizumab (Test)
Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
A Study of Two Formulations of Ixekizumab in Healthy Participants
Baseline characteristics by cohort
| Measure |
80 mg Ixekizumab (Reference)
n=126 Participants
Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI.
|
80 mg Ixekizumab (Test)
n=119 Participants
Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
126 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post DosePopulation: Only participants who had all PK samples collected up to Day 85 or participants who had one missing PK sample after Day 15 but with at least 3 data points and R squared adjusted (Rsq adj) greater than (\>) 0.7 to calculate half-life parameter included in the analysis.
PK: Cmax of ixekizumab was evaluated
Outcome measures
| Measure |
80 mg Ixekizumab (Reference)
n=112 Participants
Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI.
|
80 mg Ixekizumab (Test)
n=110 Participants
Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab
|
9.66 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 33
|
9.97 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post DosePopulation: Only participants who had all PK samples collected up to Day 85 or participants who had one missing PK sample after Day 15 but with at least 3 data points and Rsq adj\>0.7 to calculate half-life parameter included in the analysis.
Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC\[0-tlast\]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days.
Outcome measures
| Measure |
80 mg Ixekizumab (Reference)
n=112 Participants
Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI.
|
80 mg Ixekizumab (Test)
n=110 Participants
Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab
|
207 microgram*day/milliliter (ug*day/mL)
Geometric Coefficient of Variation 31
|
219 microgram*day/milliliter (ug*day/mL)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post DosePopulation: Only participants who had all PK samples collected up to Day 85 or participants who had one missing PK sample after Day 15 but with at least 3 data points and Rsq adj\>0.7 to calculate half-life parameter included in the analysis.
Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab.
Outcome measures
| Measure |
80 mg Ixekizumab (Reference)
n=112 Participants
Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI.
|
80 mg Ixekizumab (Test)
n=110 Participants
Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab
|
213 ug*day/mL
Geometric Coefficient of Variation 33
|
227 ug*day/mL
Geometric Coefficient of Variation 30
|
Adverse Events
80 mg Ixekizumab (Reference)
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
80 mg Ixekizumab (Test)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
80 mg Ixekizumab (Reference)
n=126 participants at risk
Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI.
|
80 mg Ixekizumab (Test)
n=119 participants at risk
Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
|
|---|---|---|
|
General disorders
Injection site reaction
|
23.8%
30/126 • Number of events 30 • Up to 85 Days
All randomized participants who received at least one dose of study drug.
|
9.2%
11/119 • Number of events 11 • Up to 85 Days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
7.1%
9/126 • Number of events 11 • Up to 85 Days
All randomized participants who received at least one dose of study drug.
|
2.5%
3/119 • Number of events 3 • Up to 85 Days
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60