A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073213
• Other study ID #: 15371
• Secondary ID: I1F-MC-RHBN
• Status: Completed
• Phase: Phase 1
• Start date: April 13, 2017
• Est. completion date: May 14, 2019

Study information

• Verified date: June 1, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Ixekizumab
Administered as subcutaneous (SC) injection

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	Second Affiliate Hospital of Zhejiang Medical University	Hangzhou	Zhejiang
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)	Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.	Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Primary	Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)	Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.	Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Primary	Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)	Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.	day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197
Primary	Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)	Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).	day 57 (Pre-dose), 59, 61, 64, 67, 71
Primary	Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)	Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).	day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85