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Plaque PsoriasisPhase 4IXORA-RNCT03573323

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

A Phase 4 study testing Ixekizumab and Guselkumab in people with Plaque Psoriasis, run by Eli Lilly and Company at 124 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Ixekizumab and Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,027 participants
Where
124 sitesin 3 countries
Study dates
9 Nov 2018to 8 Jan 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (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.

Who cannot join

  • 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.
Show all 13Show fewer
  • Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating 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).

Trial locations and contacts

124 sites in 3 countries.

124 sites in 3 countries

United States98 sites

  • Atlanta Dermatology, Vein Research Center, PC

    Alpharetta, Georgia, 30022

  • Fivenson Dermatology

    Ann Arbor, Michigan, 48103

  • Arlington Research Center, Inc

    Arlington, Texas, 76011

  • Austin Institute for Clinical Research, Inc.

    Austin, Texas, 78705

  • Bakersfield Dermatology and Skin Cancer Medical Group

    Bakersfield, California, 93309

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Bellaire Dermatology

    Bellaire, Texas, 77401

  • ActivMed Practices & Research, Inc

    Beverly, Massachusetts, 01915

  • Wallace Medical Group, Inc.

    Beverly Hills, California, 90211

  • Bexley Dermatology Research

    Bexley, Ohio, 43209

  • Total Skin and Beauty Dermatology Center PC

    Birmingham, Alabama, 35205

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, 29407

  • Piedmont Plastic Surgery and Dermatology

    Charlotte, North Carolina, 28277

  • Clarkston Skin Research

    Clarkston, Michigan, 48346

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Florida Academic Dermatology Centers

    Coral Gables, Florida, 33134

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Modern Research Associates PLLC

    Dallas, Texas, 75231

  • Henry Ford Medical Center- New Center One

    Detroit, Michigan, 48202

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • California Dermatology and Clinical Research Institute

    Encinitas, California, 92024

  • Qualmedica Research LLC

    Evansville, Indiana, 47715

  • Dermatology and Skin Surgery Center

    Exton, Pennsylvania, 19341

  • Wright State Univ School of Medicine

    Fairborn, Ohio, 45324

  • Forest Hills Dermatology Group

    Forest Hills, New York, 11375

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916

  • Tien Q. Nguyen, MD inc. DBA First OC Dermatology

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California, 94538

  • Ohio State Univ College Of Medicine

    Gahanna, Ohio, 43230

  • Dermatology Consulting Services

    High Point, North Carolina, 27262

  • Center for Clinical Studies

    Houston, Texas, 77004

  • Suzanne Bruce and Associates, PA

    Houston, Texas, 77056

  • Dawes Fretzin Clinical Research

    Indianapolis, Indiana, 46250

  • Clinical Partners LLC

    Johnston, Rhode Island, 02919

  • Olympian Clinical Research

    Largo, Florida, 33770

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • Advanced Research Center

    Los Alamitos, California, 90720

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • Dermatology Specialist

    Louisville, Kentucky, 40241

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217

  • Dermatologists of Southwest Ohio, Inc.

    Mason, Ohio, 45040

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Miami Dermatology & Laser Research

    Miami, Florida, 33173

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • West Virginia Research Institute

    Morgantown, West Virginia, 26505

  • International Clinical Research

    Murfreesboro, Tennessee, 37130

  • University of Utah MidValley Dematology

    Murray, Utah, 84107

  • Dermatology Specialists Research Indiana

    New Albany, Indiana, 47150

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Sadick Research Group

    New York, New York, 10075

  • Dermatology Clinical Trials

    Newport Beach, California, 92660

  • Virginia Clinical Research

    Norfolk, Virginia, 23502

  • Virginia Dermatology & Skin Cancer Center

    Norfolk, Virginia, 23502

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Quest Dermatology Research

    Northridge, California, 91324

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • Park Avenue Dermatology

    Orange Park, Florida, 32073

  • Kansas City Dermatology, PA

    Overland Park, Kansas, 66215

  • Owensboro Dermatology Associates

    Owensboro, Kentucky, 42303

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Alliance Dermatology and Mohs Center

    Phoenix, Arizona, 85032

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168

  • Oregon Medical Research Center

    Portland, Oregon, 97223

  • ActivMed Practices & Research, Inc

    Portsmouth, New Hampshire, 03801

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294

  • Lawrence J Green, M.D, LLC

    Rockville, Maryland, 20850

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina, 27804

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008

  • Northern California Research Corporation

    Sacramento, California, 95821

  • St Joseph Dermatology and Vein Clinic

    Saint Joseph, Michigan, 49085

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • Stephen L Miller, MD, PA

    San Antonio, Texas, 78249

  • Advanced Research Center

    San Diego, California, 92103

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • University Clinical Trials, Inc.

    San Diego, California, 92123

  • Synergy Dermatology

    San Francisco, California, 94132

  • International Clinical Research

    Sanford, Florida, 32771

  • Southern California Dermatology

    Santa Ana, California, 92701

  • Mosaic Dermatology

    Santa Monica, California, 90403

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Perseverance Research Center

    Scottsdale, Arizona, 85254

  • Dermatology Associates

    Seattle, Washington, 98101

  • Dermatology Physicians of Connecticut

    Shelton, Connecticut, 06484

  • Unison Clinical Trials

    Sherman Oaks, California, 91403

  • The South Bend Clinic

    South Bend, Indiana, 46617

  • Central Dermatology PC

    St Louis, Missouri, 63117

  • MOORE Clinical Research

    Tampa, Florida, 33609

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Olympian Clinical Research

    Tampa, Florida, 33614

  • Care Access Research-Walnut Creek

    Walnut Creek, California, 94598

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Dermatology Institute of Dupage Medical Group

    Wheaton, Illinois, 60189

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28411

  • Yardley Dermatology

    Yardley, Pennsylvania, 19067

Other trials in United States

Canada20 sites

  • Dermatology Research Institute Inc.

    Calgary, Alberta, T1Y 0B4

  • Kirk Barber Research

    Calgary, Alberta, T2G 1B1

  • Dr Isabelle Delorme Inc.

    Drummondville, Quebec, J2B 5L4

  • Stratica Medical

    Edmonton, Alberta, T5K 1X3

  • Eastern Canada Cutaneous Research Assoicates Ltd

    Halifax, Nova Scotia, B3H1Z2

  • Dermatrials Research Inc.

    Hamilton, Ontario, L8N 1Y2

  • Mediprobe Research Inc

    London, Ontario, N5X 2P1

  • The Guenther Dermatology Research Centre

    London, Ontario, N6A 3H7

  • Lynderm Research Inc

    Markham, Ontario, L3P1X2

  • DermEdge Research Inc

    Mississauga, Ontario, L5H 1G9

  • Innovaderm Research Inc

    Montreal, Quebec, H2K4L5

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B 3Z7

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • The Centre for Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • Q&T Research Sherbrooke Inc

    Sherbrooke, Quebec, J1J 2G2

  • Karma Clinical Trials Inc

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research

    Surrey, British Columbia, V3V 0C6

  • K. Papp Clinical Research Inc

    Waterloo, Ontario, N2J 1C4

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Puerto Rico6 sites

  • Santa Cruz Behavioral PSC

    Bayamón, 00961-6911

  • Centro Reumatologico de Caguas

    Caguas, PR, 00725

  • Office of Dr. Samuel Sanchez PSC

    Caguas, PR, 00727

  • Ponce School of Medicine CAIMED Center

    Ponce, PR, 00716

  • GCM Medical Group PSC

    San Juan, PR, 00909

  • Mindful Medical Research

    San Juan, PR, 00918

Other trials in Puerto Rico

About this study

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

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

Being tested
Ixekizumab, Guselkumab, Placebo
Keywords
biologic, biologic therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxekizumabDrug

    Also called LY2439821

    Administered SC

  • GuselkumabDrug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT03573323
Study groupRoleWhat they receive
IxekizumabExperimentalA starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Receives: Drug: Ixekizumab
GuselkumabExperimentalDuring the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Receives: Drug: Guselkumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)

    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 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

    Measured: Week 12

Secondary outcomes (8)

  1. Percentage of Participants Achieving PASI 75

    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 the PASI scores compared to baseline.

    Measured: Week 2

  2. Percentage of Participants Achieving PASI 90

    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 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

    Measured: Week 4

  3. Percentage of Participants Achieving PASI 100

    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 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

    Measured: Week 4

  4. Percentage of Participants Achieving PASI 90

    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 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

    Measured: Week 8

  5. Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)

    The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.

    Measured: Week 12

  6. Percentage of Participants Achieving PASI 50

    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 50 were defined as having an improvement of at least 50% in the PASI scores compared to baseline.

    Measured: Week 1

  7. Percentage of Participants Achieving PASI 100

    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 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

    Measured: Week 8

  8. Percentage of Participants Achieving PASI 100

    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 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start9 Nov 2018
  3. Primary completion15 Jul 2019
  4. Study completion8 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,027 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573323
Sponsor's protocol ID
17119
Other IDs
I1F-MC-RHCR
Acronym
IXORA-R
Status last verified
Feb 2020
First submitted
20 Jun 2018
Last updated
28 Jul 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Armstrong A, Gonzalez-Cantero A, Khattri S, Muzy G, Malatestinic WN, Lampropoulou A, Feely M, See SK, Mert C, Blauvelt A. Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies. Dermatol Ther (Heidelb). 2024 Apr;14(4):933-952. doi: 10.1007/s13555-024-01136-w. Epub 2024 Mar 23.

    PubMed 38521874

  • Gooderham M, Vender R, Crowley J, Hong HC, Feely M, Garrelts A, See K, Konicek B, Green L. Speed and Cumulative Responses According to Body Regions in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Ixekizumab (Interleukin-17A Antagonist) versus Guselkumab (Interleukin-23p19 Inhibitor). Dermatol Ther (Heidelb). 2024 Feb;14(2):441-451. doi: 10.1007/s13555-023-01075-y. Epub 2024 Feb 9.

    PubMed 38332436

  • Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.

    PubMed 35279805

  • Blauvelt A, Leonardi C, Elewski B, Crowley JJ, Guenther LC, Gooderham M, Langley RG, Vender R, Pinter A, Griffiths CEM, Tada Y, Elmaraghy H, Lima RG, Gallo G, Renda L, Burge R, Park SY, Zhu B, Papp K; IXORA-R Study Group. A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial. Br J Dermatol. 2021 Jun;184(6):1047-1058. doi: 10.1111/bjd.19509. Epub 2020 Oct 25.

    PubMed 32880909

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ixekizumab and Guselkumab in people with Plaque Psoriasis, run by Eli Lilly and Company at 124 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03573323, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

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