HealthyPhase 1NCT03848403

Study of Ixekizumab in Healthy Participants

A Phase 1 study testing Ixekizumab in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions [ISRs]) will be collected. 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: 70 participants
Where: 2 sitesUnited States
Study dates: 29 Jan 2019to 18 Jul 2019
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

Healthy male participants or female participants who agree not to get pregnant
Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant 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
Have dullness or loss of sensitivity on either side of your abdomen
Have any condition that could affect pain perception from an injection
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 all 10Show fewer

Show evidence of active or latent tuberculosis (TB)
Presence of significant neuropsychiatric disorder or a recent history of depression
Have excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments
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 if participating in the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Covance
Dallas, Texas, 75247-4989
Covance Clinical Research Inc
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Randomized Study to Investigate Injection-Site Pain Following Subcutaneous Injections of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation Using a Pre-filled Syringe 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.

IxekizumabBiological
Also called LY2439821
Administered SC

Study groups in NCT03848403
Study group	Role	What they receive
Ixekizumab (Reference)	Experimental	Reference formulation 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods. Receives: Biological: Ixekizumab
Ixekizumab (Test 1)	Experimental	Test 1 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods. Receives: Biological: Ixekizumab
Ixekizumab (Test 2)	Experimental	Test 2 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods. Receives: Biological: Ixekizumab

What is being measured

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

Injection Pain Visual Analog Scale (VAS) Score
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).
Measured: Day 1, 8, and 15: Immediately (within 1 minute) after injection

Timeline

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

29 Jan 201918 Jul 2019

First posted20 Feb 2019
Study start29 Jan 2019
Primary completion18 Jul 2019
Study completion18 Jul 2019

Why it stopped: At the protocol-specified interim analysis, the sponsor decided to stop the trial.

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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03848403
Sponsor's protocol ID: 17139
Other IDs: I1F-MC-RHCS
Status last verified: Nov 2022
First submitted: 19 Feb 2019
Last updated: 30 Nov 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 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Study to Investigate Injection-Site Pain Following Subcutaneous Injections of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation Using a Pre-filled Syringe in Healthy Subjects
ClinicalTrials.gov ID: NCT03848403
Acronym / sponsor ID: 17139
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: At the protocol-specified interim analysis, the sponsor decided to stop the trial.
Enrolment: 70 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 29 Jan 2019 (actual)
Primary completion: 18 Jul 2019 (actual)
Study completion: 18 Jul 2019 (actual)
First posted: 20 Feb 2019 (actual)
Results: Posted 30 Jul 2020

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: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Ixekizumab (Reference)	Experimental	Biological: IxekizumabReference formulation 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.
Ixekizumab (Test 1)	Experimental	Biological: IxekizumabTest 1 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
Ixekizumab (Test 2)	Experimental	Biological: IxekizumabTest 2 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy male participants or female participants who agree not to get pregnant
Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study

Key exclusion criteria (10 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
Have dullness or loss of sensitivity on either side of your abdomen
Have any condition that could affect pain perception from an injection
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

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	Biological	Ixekizumab (Reference), Ixekizumab (Test 1), Ixekizumab (Test 2)

Primary outcome

Injection Pain Visual Analog Scale (VAS) Score
Time frame: Day 1, 8, and 15: Immediately (within 1 minute) after injection
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).

Results and safety

Results posted to the registry on 30 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: ABC	24	24
Sequence 2: BCA	24	24
Sequence 3: CAB	22	22

Primary outcome: Injection Pain Visual Analog Scale (VAS) Score

Time frame: Day 1, 8, and 15: Immediately (within 1 minute) after injection. Mean (Standard Deviation). Unit: millimeter (mm)

Measure	Ixekizumab (Reference) n = 61	Ixekizumab (Test 1) n = 63	Ixekizumab (Test 2) n = 61
Value	25.3 (24.7)	3.3 (7.0)	4.1 (8.2)

Ixekizumab (Reference) vs Ixekizumab (Test 1): Least Squares (LS) Means Difference: -21.69 (95% CI -26.90 to -16.48), p <0.0001, Mixed Models Analysis
Ixekizumab (Reference) vs Ixekizumab (Test 2): LS Means Difference: -21.14 (95% CI -26.39 to -15.88), p <0.0001, Mixed Models Analysis
Ixekizumab (Test 1) vs Ixekizumab (Test 2): LS Means Difference: 0.55 (95% CI -4.65 to 5.75), p = 0.8341, Mixed Models Analysis

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

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
Ixekizumab (Reference)	0 of 61 (0%)	3 of 61 (4.9%)	0 of 61
Ixekizumab (Test 1)	0 of 63 (0%)	5 of 63 (7.9%)	0 of 63
Ixekizumab (Test 2)	0 of 61 (0%)	6 of 61 (9.8%)	0 of 61

Limitations and caveats (from the sponsor): At protocol-specified interim analysis, the sponsor decided to stop trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 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

2 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 2 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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 30 Jul 2020). 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?

Injection Pain Visual Analog Scale (VAS) Score (time frame: Day 1, 8, and 15: Immediately (within 1 minute) after injection). 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 NCT03848403, 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 30 Nov 2022.