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Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis (Ixora-peds)

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ClinicalTrials.gov Identifier: NCT03073200
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : November 14, 2019
Estimated Study Completion Date : June 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Ixekizumab
Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Placebo Comparator: Placebo
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Proportion of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [ Time Frame: Week 12 ]
    Proportion of participants with a PASI 75

  2. Proportion of Participants with a Static Physician Global Assessment (sPGA) (0,1) [ Time Frame: Week 12 ]
    Proportion of participants with a sPGA (0,1)


Secondary Outcome Measures :
  1. Proportion of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) [ Time Frame: Week 12 ]
    Proportion of participants with a PASI 90

  2. Proportion of Participants with a sPGA (0) [ Time Frame: Week 12 ]
    Proportion of participants with a sPGA (0)

  3. Proportion of Participants with a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [ Time Frame: Week 12 ]
    Proportion of participants with a PASI 100

  4. Proportion of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [ Time Frame: Week 2 ]
    Proportion of participants with a PASI 75

  5. Proportion of Participants with a Static Physician Global Assessment (sPGA) (0,1) [ Time Frame: Week 2 ]
    Proportion of participants with a sPGA (0,1)

  6. Proportion of Participants with an Improvement of ≥4 for those who had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4 [ Time Frame: Week 12 ]
    Proportion of participants with an improvement of ≥4 for those who had a baseline itch NRS score of ≥4

  7. Proportion of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1) [ Time Frame: Week 12 ]
    Proportion of Participants Achieving CDLQI/DLQI (0/1)

  8. Change from Baseline on the Nail Psoriasis Severity Index (NAPSI) [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the NAPSI

  9. Change from Baseline on the Psoriasis Severity Index (PSSI) [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the PSSI

  10. Change from Baseline on the Palmoplantar Psoriasis Severity Index (PPASI) [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the PPASI

  11. Number of Participants with Anti-Ixekizumab Antibodies [ Time Frame: Baseline through Week 48 ]
    Number of participants with anti-ixekizumab antibodies

  12. Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss) [ Time Frame: Week 12 ]
    PK: Trough ixekizumab concentration at steady state (Ctrough ss)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.
  • Have PASI score ≥12 and a sPGA ≥3 and body surface area involvement ≥10% at screening and baseline.
  • Are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies.
  • Male subjects agree to use a reliable method of birth control during the study.
  • Female subjects are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks following the last dose of investigational product, whichever is longer.
  • Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.
  • All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific pediatric authorities (e.g., the American Academy of Pediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.

Exclusion Criteria:

  • Have pustular, erythrodermic, and/or guttate forms of psoriasis.
  • Have drug-induced psoriasis.
  • Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).
  • Participants with a documented history of immune deficiency syndrome.
  • Have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline.
  • Subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
  • Have used any therapeutic agent targeted at reducing interleukin-17.
  • Have received other therapies within the specified timeframes below:

    • adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives prior to baseline.
    • systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy [psoralen plus ultraviolet A]) in the previous 4 weeks.

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): NCT03073200


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-284-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

  Show 81 Study Locations
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03073200     History of Changes
Other Study ID Numbers: 16367
I1F-MC-RHCD ( Other Identifier: Eli Lilly and Company )
2016-003331-38 ( EudraCT Number )
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 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.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
children
psoriasis treatment
adolescents

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