Study of Ixekizumab in Healthy Participants

NCT03848403 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 17139I1F-MC-RHCS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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).

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

Study Arms (3)

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.

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.

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.

Biological: Ixekizumab

Interventions

Ixekizumab BIOLOGICAL

Administered SC

Also known as: LY2439821

Ixekizumab (Reference); Ixekizumab (Test 1); Ixekizumab (Test 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Covance

Dallas, Texas, 75247-4989, United States

Location

Covance Clinical Research Inc

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• 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.

  PMID: 35449322 DERIVED

MeSH Terms

Interventions

ixekizumab

Limitations and Caveats

At protocol-specified interim analysis, the sponsor decided to stop trial.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: January 29, 2019
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: November 30, 2022
• Results First Posted: July 30, 2020

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)