HealthyPhase 1NCT04259346

A Study of Two Formulations of Ixekizumab in Healthy Participants

A Phase 1 study testing Ixekizumab in people with Healthy, run by Eli Lilly and Company at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved. This study will compare how much of each formulation gets into the blood stream. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ixekizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 245 participants
Where: 4 sitesUnited States
Study dates: 5 Feb 2020to 19 Feb 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Are healthy male or female participants, with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study

Who cannot join

Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
Are allergic or hypersensitive to the study medicine
Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
Show evidence of active or latent tuberculosis (TB)
Presence of significant neuropsychiatric disorder or a recent history of depression
Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator, would pose an unacceptable risk to the participant

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Covance Dallas
Dallas, Texas, 75247
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
Covance Clinical Research Inc
Madison, Wisconsin, 53704
Miami Research Associates
Miami, Florida, 33143

Other trials in United States

About this study

Official title: Bioequivalence of an Alternate Ixekizumab Formulation Compared to the Commercial Formulation in Healthy Subjects

Conditions: Healthy
Being tested: Ixekizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IxekizumabDrug
Also called LY2439821
Administered SC.

Study groups in NCT04259346
Study group	Role	What they receive
Ixekizumab (Reference)	Experimental	Approved formulation of 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection via autoinjector (AI). Receives: Drug: Ixekizumab
Ixekizumab (Test)	Experimental	Test formulation of 80 mg ixekizumab administered as a SC injection via AI. Receives: Drug: Ixekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab
PK: Cmax of ixekizumab was evaluated
Measured: 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
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab
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.
Measured: 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
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab
Area under the plasma concentration versus time curve from zero to infinity (AUC[0-∞]) of a single dose of Ixekizumab.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 202019 Feb 2021

First posted6 Feb 2020
Study start5 Feb 2020
Primary completion19 Feb 2021
Study completion19 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04259346
Sponsor's protocol ID: 17151
Other IDs: I1F-MC-RHCU
Status last verified: 1 Feb 2022
First submitted: 5 Feb 2020
Last updated: 8 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Chabra S, Gill BJ, Gallo G, Zhu D, Pitou C, Payne CD, Accioly A, Puig L. Ixekizumab Citrate-Free Formulation: Results from Two Clinical Trials. Adv Ther. 2022 Jun;39(6):2862-2872. doi: 10.1007/s12325-022-02126-0. Epub 2022 Apr 21.
PubMed 35449322

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of an Alternate Ixekizumab Formulation Compared to the Commercial Formulation in Healthy Subjects
ClinicalTrials.gov ID: NCT04259346
Acronym / sponsor ID: 17151
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 245 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 5 Feb 2020 (actual)
Primary completion: 19 Feb 2021 (actual)
Study completion: 19 Feb 2021 (actual)
First posted: 6 Feb 2020 (actual)
Results: Posted 8 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Ixekizumab (Reference)	Experimental	Drug: IxekizumabApproved formulation of 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection via autoinjector (AI).
Ixekizumab (Test)	Experimental	Drug: IxekizumabTest formulation of 80 mg ixekizumab administered as a SC injection via AI.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Are healthy male or female participants, with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study

Key exclusion criteria (7 listed)

Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
Are allergic or hypersensitive to the study medicine
Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
Show evidence of active or latent tuberculosis (TB)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IxekizumabAlso: LY2439821Administered SC.	Drug	Ixekizumab (Reference), Ixekizumab (Test)

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab
Time frame: 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
PK: Cmax of ixekizumab was evaluated
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab
Time frame: 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
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.
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab
Time frame: 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
Area under the plasma concentration versus time curve from zero to infinity (AUC[0-∞]) of a single dose of Ixekizumab.

Results and safety

Results posted to the registry on 8 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
80 Milligram (mg) Ixekizumab (Reference)	126	122
80 mg Ixekizumab (Test)	119	115

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliliter (ug/mL)

Measure	80 mg Ixekizumab (Reference) n = 112	80 mg Ixekizumab (Test) n = 110
Value	9.66 (33)	9.97 (35)

Population analysed: 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.

Primary outcome: PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab

Measure	80 mg Ixekizumab (Reference) n = 112	80 mg Ixekizumab (Test) n = 110
Value	207 (31)	219 (28)

Population analysed: 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.

Primary outcome: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ug*day/mL

Measure	80 mg Ixekizumab (Reference) n = 112	80 mg Ixekizumab (Test) n = 110
Value	213 (33)	227 (30)

Population analysed: 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.

Adverse events

Time frame: Up to 85 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
80 mg Ixekizumab (Reference)	0 of 126 (0%)	36 of 126 (28.6%)	0 of 126
80 mg Ixekizumab (Test)	0 of 119 (0%)	14 of 119 (11.8%)	0 of 119

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35449322Chabra S, Gill BJ, Gallo G, Zhu D, Pitou C, Payne CD, Accioly A, Puig L. Ixekizumab Citrate-Free Formulation: Results from Two Clinical Trials. Adv Ther. 2022 Jun;39(6):2862-2872. doi: 10.1007/s12325-022-02126-0. Epub 2022 Apr 21.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ixekizumab in people with Healthy, run by Eli Lilly and Company at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.