Phase 1
Completed N=12
A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris
Source: ClinicalTrials.gov NCT03073213 ↗Enrolled (actual)
12
Serious AEs
2.4%
Results posted
Jul 2020
Primary outcomePrimary: Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) — 6.90 Microgram per milliliter (ug/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) |
6.90 | — |
| PRIMARY Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose) |
147 | — |
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose) |
19.9; 13.4 | — |
| PRIMARY Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose) |
224; 136 | — |
| PRIMARY Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose) |
213 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03073213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.