Trial Outcomes & Findings for Study of Ixekizumab in Healthy Participants (NCT NCT03848403)

Last Updated: 2022-11-30

Results Overview

The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (\>30 and ≤70), and severe pain (\>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

70 participants

Primary outcome timeframe

Day 1, 8, and 15: Immediately (within 1 minute) after injection

Results posted on

2022-11-30

Participant Flow

Participants were randomized to a treatment sequence in one of three periods. The study was stopped for some participants per sponsor decision and these participants did not move on to subsequent periods in the study at the protocol interim analysis.

Participant milestones

Participant milestones
Measure	Sequence 1: ABC A: Reference formulation 80 milligram (mg) of Ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in Period 1. B: Test 1 formulation 80 mg of Ixekizumab administered as an subcutaneous SC injection in a prefilled syringe in Period 2. C: Test 2 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 3. Sequence 1: ABC (Reference, Test 1, then Test 2)	Sequence 2: BCA B: Test 1 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 1. C: Test 2 formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 2. A: Reference formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 3. Sequence 2: BCA (Test 1, Test 2, Then Reference)	Sequence 3: CAB C: Test 2 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 1. A: Reference: formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 2. B: Test 1 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 3. Sequence 3: CAB (Test 2, Reference, Then Test 1)
Period 1 (Day 1) STARTED	24	24	22
Period 1 (Day 1) Received Intervention	24	24	22
Period 1 (Day 1) COMPLETED	24	24	22
Period 1 (Day 1) NOT COMPLETED	0	0	0
Period 2 (Day 8) STARTED	24	24	22
Period 2 (Day 8) Received at Least One Dose of Study Drug	24	24	22
Period 2 (Day 8) COMPLETED	15	15	15
Period 2 (Day 8) NOT COMPLETED	9	9	7
Period 3 (Day 15) STARTED	15	15	15
Period 3 (Day 15) COMPLETED	15	15	15
Period 3 (Day 15) NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1: ABC A: Reference formulation 80 milligram (mg) of Ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in Period 1. B: Test 1 formulation 80 mg of Ixekizumab administered as an subcutaneous SC injection in a prefilled syringe in Period 2. C: Test 2 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 3. Sequence 1: ABC (Reference, Test 1, then Test 2)	Sequence 2: BCA B: Test 1 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 1. C: Test 2 formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 2. A: Reference formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 3. Sequence 2: BCA (Test 1, Test 2, Then Reference)	Sequence 3: CAB C: Test 2 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 1. A: Reference: formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 2. B: Test 1 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 3. Sequence 3: CAB (Test 2, Reference, Then Test 1)
Period 2 (Day 8) Adverse Event	1	2	2
Period 2 (Day 8) Physician Decision	0	1	0
Period 2 (Day 8) Sponsor Decision	8	6	5

Baseline Characteristics

Study of Ixekizumab in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=70 Participants All randomized participants who received at least one 80 milligram (mg) dose of ixekizumab administered as an SC injection in a prefilled syringe in one of three periods.
Age, Continuous	44.5 Years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, 8, and 15: Immediately (within 1 minute) after injection

Population: All randomized participants who received at least one dose of study drug in a treatment sequence.

Outcome measures

Outcome measures
Measure	Ixekizumab (Reference) n=61 Participants Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.	Ixekizumab (Test 1) n=63 Participants Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe in one of three study periods.	Ixekizumab (Test 2) n=61 Participants Test 2 formulation ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
Injection Pain Visual Analog Scale (VAS) Score	25.3 millimeter (mm) Standard Deviation 24.7	3.3 millimeter (mm) Standard Deviation 7.0	4.1 millimeter (mm) Standard Deviation 8.2

Adverse Events

Ixekizumab (Reference)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ixekizumab (Test 1)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Ixekizumab (Test 2)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ixekizumab (Reference) n=61 participants at risk Reference formulation 80 mg ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.	Ixekizumab (Test 1) n=63 participants at risk Test 1 formulation ixekizumab 80mg administered as an SC injection in a prefilled syringe in one of three study periods.	Ixekizumab (Test 2) n=61 participants at risk Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe in one of three study periods.
General disorders Injection site reaction	4.9% 3/61 • Number of events 3 • Up to 85 Days All randomized participants who received at least one dose of intervention.	7.9% 5/63 • Number of events 7 • Up to 85 Days All randomized participants who received at least one dose of intervention.	9.8% 6/61 • Number of events 8 • Up to 85 Days All randomized participants who received at least one dose of intervention.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60