A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

NCT03073213 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 15371I1F-MC-RHBN
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Ixekizumab single dose

EXPERIMENTAL

Participants received single dose of 80mg Ixekizumab by subcutaneous injection.

Drug: Ixekizumab

Ixekizumab Multiple Regimen 1 (80mg Q2W)

EXPERIMENTAL

Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.

Drug: Ixekizumab

Ixekizumab Multiple Regimen 2 (80mg Q4W)

EXPERIMENTAL

Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.

Drug: Ixekizumab

Interventions

Ixekizumab DRUG

Administered as subcutaneous (SC) injection

Also known as: LY2439821

Ixekizumab Multiple Regimen 1 (80mg Q2W); Ixekizumab Multiple Regimen 2 (80mg Q4W); Ixekizumab single dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

Second Affiliate Hospital of Zhejiang Medical University

Hangzhou, Zhejiang, 310009, China

Location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, 200025, China

Location

Related Publications (1)

• Zheng M, Chen X, Wang F, Chen J, Jackson K, Yang F, Payne C, Li H, Wang Y, Xiao Z, Zheng J. Pharmacokinetics, Safety, and Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 1, Single- and Multiple-Dose Study. Adv Ther. 2023 Sep;40(9):3804-3816. doi: 10.1007/s12325-023-02575-1. Epub 2023 Jun 25.

  PMID: 37356077 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: April 13, 2017
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: July 22, 2020
• Results First Posted: July 22, 2020

Record last verified: 2019-06-01

Locations

CN (3)