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A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis (IXORA-R)

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ClinicalTrials.gov Identifier: NCT03573323
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Ixekizumab Drug: Guselkumab Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 24-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : May 28, 2019
Estimated Study Completion Date : November 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Ixekizumab
Ixekizumab administered subcutaneously (SC).
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Experimental: Guselkumab
Guselkumab administered SC. Placebo administered SC to maintain the blind.
Drug: Guselkumab
Administered SC

Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Proportion of Participants Achieving 100% Improvement from Baseline in Psoriasis Area and Severity Index (PASI 100) [ Time Frame: Week 12 ]
    Proportion of participants achieving 100% improvement from baseline in PASI (PASI 100)


Secondary Outcome Measures :
  1. Proportion of Participants Achieving PASI 75 [ Time Frame: Week 2 ]
    Proportion of participants achieving PASI 75

  2. Proportion of Participants Achieving PASI 90 [ Time Frame: Week 4 ]
    Proportion of participants achieving PASI 90

  3. Proportion of Participants Achieving PASI 90 [ Time Frame: Week 8 ]
    Proportion of participants achieving PASI 90

  4. Proportion of Participants Achieving PASI 100 [ Time Frame: Week 4 ]
    Proportion of participants achieving PASI 100

  5. Proportion of Participants Achieving PASI 100 [ Time Frame: Week 8 ]
    Proportion of participants achieving PASI 100

  6. Proportion of Participants Achieving PASI 100 [ Time Frame: Week 24 ]
    Proportion of participants achieving PASI 100

  7. Proportion of Participants Achieving Static Physician Global Assessment (sPGA) (0) [ Time Frame: Week 12 ]
    Proportion of participants achieving sPGA (0)

  8. Proportion of Participants Achieving PASI 50 [ Time Frame: Week 1 ]
    Proportion of participants achieving PASI 50



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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:

  • Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
  • Are a candidate for phototherapy and/or systemic therapy.
  • Have both an sPGA score of ≥3 and a PASI score ≥12 at screening and at baseline.
  • Have ≥10% body surface area (BSA) involvement at screening and baseline.
  • If a male, agree to use a reliable method of birth control during the study.
  • If female, agree to use highly effective method of contraception.

Exclusion Criteria:

  • Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
  • Have a history of drug-induced psoriasis.
  • Had a clinically significant flare of psoriasis during the 12 weeks before baseline.
  • Use of tanning booths for at least 4 weeks before baseline.
  • Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept <28 days; infliximab, adalimumab, certolizumab pegol, or alefacept <60 days; golimumab <90 days; rituximab <12 months; secukinumab <5 months; or any other biologic agent (e.g., ustekinumab) <5 half lives.
  • Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.
  • Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating other IL-17 or IL-23p19 antagonists, or have received treatment with ixekizumab.
  • Have previously failed to respond to an IL-17 antagonist, per investigator assessment.
  • Have had a live vaccination within 12 weeks of baseline.
  • Have a known allergy or hypersensitivity to any biologic therapy.
  • Have had any major surgery within 8 weeks of baseline.
  • Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.
  • Are women who are pregnant, or who are lactating (breast-feeding).

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): NCT03573323


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

  Show 133 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03573323     History of Changes
Other Study ID Numbers: 17119
I1F-MC-RHCR ( Other Identifier: Eli Lilly and Company )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: December 13, 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:
biologic
biologic therapy

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