Taltz® (Ixekizumab)

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Ixekizumab: Bioequivalence Studies in Healthy Participants

A phase 1 study is comparing the FDA-approved ixekizumab formulation to a test formulation.

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Study Design Overview

This medical response may not completely match the information in the current local labeling for iXEKIZUMAB. Please see local labeling for approved label information.

Study RHCU is a subject-blind, randomized, parallel assignment, phase 1 trial comparing the approved ixekizumab formulation to a test formulation in healthy subjects to compare how much of each formulation gets into the blood stream. Participants will receive either the approved formulation or the test formulation subcutaneously via autoinjector. Study participation will last up to about four months for each participant.1

Study Participation Criteria

Study inclusion requirements include

  • being a healthy male or female, aged 18 to 75 years, who agrees to not become pregnant, or
  • having chronic stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study.1

Exclusion criteria include having

  • current or significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that, in the opinion of the investigator, poses an unacceptable risk to the participant
  • allergy or hypersensitivity to the study medicine
  • received a vaccination with a live vaccine within 12 months prior to the first check-in or intention to receive a vaccine for TB within 12 months of completing treatment on this study
  • any type of hepatitis, HIV infection, or other serious infection
  • evidence of active or latent TB
  • a significant neuropsychiatric disorder or a recent history of depression, or
  • 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.1

Study Primary Outcomes

The primary outcome measures for study RHCU are the pharmacokinetic parameters (AUC and Cmax) calculated over a timeframe from baseline through day 85.1

Additional Study Design Details

Please visit www.ClinicalTrials.gov for additional information and updates regarding these trials.

 Phase 1 Study Comparing Two Formulations of Ixekizumab in Healthy Participants (RHCU)1

Design summary

Randomized, single masking (participant), parallel assignment

Estimated enrollment

216 participants

Country study locations

Three sites, United States

Treatment arms

Reference, Test formulation

Primary outcome measures

Cmax, AUC

Estimated study completion

August 6, 2020

Abbreviations: AUC = area under the concentration versus time curve; Cmax = maximum drug concentration.

Reference

1A study of two formulations of ixekizumab in healthy participants. ClinicalTrials.gov website. https://clinicaltrials.gov/show/NCT04259346. Updated February 6, 2020. Accessed February 7, 2020.

Glossary

AUC = area under the concentration versus time curve

Cmax = maximum drug concentration

HIV = human immunodeficiency virus

TB = tuberculosis

Fecha de la última revisión: 2020 M02 27


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