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Trial record 22 of 31 for:    LY2439821

A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02387801
Recruitment Status : Completed
First Posted : March 13, 2015
Results First Posted : October 21, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 9, 2015
First Posted Date  ICMJE March 13, 2015
Results First Submitted Date August 29, 2016
Results First Posted Date October 21, 2016
Last Update Posted Date June 20, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score [ Time Frame: Baseline through Week 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
Time to at Least a 1 Point Change on the Patient's Global Assessment of Disease Severity (PatGA) Score [ Time Frame: Baseline through Week 12 ]
Change History Complete list of historical versions of study NCT02387801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
  • Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 12 ]
    The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint.
  • Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 12 ]
    The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint.
  • Mean Change From Baseline in Percent Body Surface Area (%BSA) [ Time Frame: Baseline, Week 12 ]
    The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction
  • Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 12 ]
    The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction.
  • Time to at Least a 2 Point Improvement on the PatGA Score [ Time Frame: Baseline though Week 12 ]
    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 NRS the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
  • Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 12 ]
  • Mean Change From Baseline in Percent Body Surface Area (%BSA) [ Time Frame: Baseline, Week 12 ]
  • Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 12 ]
  • Time to at Least a 2 Point Change on the PatGA Score [ Time Frame: Baseline though Week 12 ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
Official Title  ICMJE Early Onset of Clinical Improvement With Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Ixekizumab
Administered SC
Other Name: LY2439821
Study Arms
  • Experimental: Ixekizumab Dosing Q2W
    160 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.
    Intervention: Drug: Ixekizumab
  • Experimental: Ixekizumab Dosing Q4W
    160 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.
    Intervention: Drug: Ixekizumab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2015)
20
Actual Study Completion Date August 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02387801
Other Study ID Numbers  ICMJE 15454
I1F-US-RHBO ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP