Trial Outcomes & Findings for A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants (NCT NCT02543918)

Last Updated: 2017-01-06

Results Overview

Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of \>=1.0 (International Unit (IU) and a \>=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is \<=1.0 at baseline OR a \>=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is \> 1.0 IU at baseline. Responder to the pneumococcal vaccine is defined as a \>=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against \>50% of the 23 serotypes.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

84 participants

Primary outcome timeframe

Week 6

Results posted on

2017-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Ixekizumab + Boostrix® + Pneumovax®23 Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.	Boostrix® + Pneumovax®23 Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
Overall Study STARTED	41	43
Overall Study Received at Least 1 Dose of Study Drug	41	42
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Ixekizumab + Boostrix® + Pneumovax®23 Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.	Boostrix® + Pneumovax®23 Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
Overall Study Never treated	0	1
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	1	1

Baseline Characteristics

A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixekizumab + Boostrix® + Pneumovax®23 n=41 Participants Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.	Boostrix® + Pneumovax®23 n=43 Participants Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.	Total n=84 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 12.2 • n=5 Participants	39.5 years STANDARD_DEVIATION 10.5 • n=7 Participants	41.4 years STANDARD_DEVIATION 11.5 • n=5 Participants
Gender Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Gender Male	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	35 Participants n=7 Participants	69 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	0 Participants n=7 Participants	0 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	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	41 participants n=5 Participants	43 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6

Population: All randomized participants who completed the study.

Outcome measures

Outcome measures
Measure	Ixekizumab + Boostrix® + Pneumovax®23 n=38 Participants Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.	Boostrix® + Pneumovax®23 n=41 Participants Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations Tetanus Vaccine Responders	52.6 percentage of participants	51.2 percentage of participants
Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations Pneumococcal Vaccine Responders	89.5 percentage of participants	90.2 percentage of participants

Adverse Events

Ixekizumab + Boostrix® + Pneumovax®23

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Boostrix® + Pneumovax®23

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ixekizumab + Boostrix® + Pneumovax®23 n=41 participants at risk Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.	Boostrix® + Pneumovax®23 n=42 participants at risk Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Infections and infestations Vulvovaginal candidiasis	5.3% 1/19 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/18 All randomized participants who received at least 1 dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: (800) 545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60