A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
Early Onset of Clinical Improvement With Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis
2 other identifiers
interventional
12
1 country
1
Brief Summary
To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
October 21, 2016
CompletedSeptember 18, 2019
September 1, 2019
5 months
March 9, 2015
August 29, 2016
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
Baseline through Week 12
Secondary Outcomes (5)
Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score
Baseline, Week 12
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)
Baseline, Week 12
Mean Change From Baseline in Percent Body Surface Area (%BSA)
Baseline, Week 12
Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)
Baseline, Week 12
Time to at Least a 2 Point Improvement on the PatGA Score
Baseline though Week 12
Study Arms (2)
Ixekizumab Dosing Q2W
EXPERIMENTAL160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
Ixekizumab Dosing Q4W
EXPERIMENTAL160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
Interventions
Eligibility Criteria
You may qualify if:
- Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
- Active psoriatic skin lesions of plaque psoriasis (Ps)
- Are a candidate for phototherapy and/or systemic therapy
- Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
You may not qualify if:
- Are unable to commit to the photography schedule for the duration of the study
- Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab
- Serious disorder or illness other than psoriasis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai School of Medicine Dermatology Clinical Trials
New York, New York, 10029, United States
Related Publications (1)
Khattri S, Goldblum O, Solotkin K, Amir Y, Min MS, Ridenour T, Yang FE, Lebwohl M. Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 May;11(5):33-37. Epub 2018 May 1.
PMID: 29785237BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2015
First Posted
March 13, 2015
Study Start
April 1, 2015
Primary Completion
September 1, 2015
Study Completion
August 1, 2016
Last Updated
September 18, 2019
Results First Posted
October 21, 2016
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.