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Trial record 22 of 29 for:    LY2439821

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

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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

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Ixekizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Onset of Clinical Improvement With Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis
Study Start Date : April 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ixekizumab

Arm Intervention/treatment
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.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

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.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387801


Locations
United States, New York
Mount Sinai School of Medicine Dermatology Clinical Trials
New York, New York, United States, 10029
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Publications:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02387801     History of Changes
Other Study ID Numbers: 15454
I1F-US-RHBO ( Other Identifier: Eli Lilly and Company )
First Posted: March 13, 2015    Key Record Dates
Results First Posted: October 21, 2016
Last Update Posted: June 20, 2018
Last Verified: May 2018
Individual Participant Data (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.


Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ixekizumab
Dermatologic Agents