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Completed

NCT Number: NCT03073213

A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xiangya Hospital, Central South University, Changsha, Hunan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females aged ≥18 years.
  • Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.
  • Candidates for phototherapy and/or systemic therapy.
  • ≥10% body surface area (BSA) involvement at screening and baseline.
  • static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.

Exclusion criteria

  • Clinically significant flare of psoriasis during the 12 weeks before baseline.
  • Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline .
  • Current or recent use of any biologic agent within the required washout periods.
  • Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.

Treatment and study plan

Ixekizumab

Drug

Administered as subcutaneous (SC) injection

Other names: LY2439821

Primary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)

    Time frame: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141

    Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.

  2. Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)

    Time frame: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141

    Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.

  3. Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)

    Time frame: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197

    Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.

  4. Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)

    Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71

    Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).

  5. Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)

    Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85

    Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Single- and Multiple-Dose Study to Assess the Safety and Pharmacokinetics of Ixekizumab (LY2439821) (Anti-IL-17 Humanized Antibody) in Chinese Patients With Psoriasis Vulgaris

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2017
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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