Clinical trial NCT03073213: A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


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.

Primary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
timeFrame: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
measure: Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
timeFrame: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
timeFrame: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197
measure: Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)
timeFrame: day 57 (Pre-dose), 59, 61, 64, 67, 71
measure: Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)
timeFrame: day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Hangzhou
country: China
facility: Second Affiliate Hospital of Zhejiang Medical University
state: Zhejiang
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: