NCT02561806|CompletedPhase 3ResultsFDA Drug

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

IXORA-S

A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis

Eli Lilly and Company ClinicalTrials.gov

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3 other identifiers

16012I1F-MC-RHBS2015-000892-28

Study Type

interventional

Target

302

Locations

13 countries

Sites

Timeline

RegisteredSep 2015

StartedOct 2015

CompletionOct 2017

Brief Summary

The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

302

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Oct 2015

Geographic Reach

13 countries

48 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

September 25, 2015

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed

3 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed

5 months until next milestone

Results Posted

Study results publicly available

February 28, 2018

Completed

Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

September 25, 2015

Results QC Date

June 28, 2017

Last Update Submit

June 10, 2020

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Week 12

Secondary Outcomes (23)

Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline
Week 12
Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline
Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline
Week 12
Percentage of Participants With a sPGA (0) Remission
Week 12
Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis
Baseline, Week 12
+18 more secondary outcomes

Study Arms (2)

Ustekinumab

ACTIVE COMPARATOR

45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.

Drug: UstekinumabDrug: Placebo

Ixekizumab

EXPERIMENTAL

160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.

Drug: IxekizumabDrug: Placebo

Interventions

IxekizumabDRUG

Administered SC

Also known as: LY2439821

Ixekizumab

UstekinumabDRUG

Administered SC

Ustekinumab

PlaceboDRUG

Administered SC

IxekizumabUstekinumab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Chronic plaque psoriasis for at least 6 months before baseline
Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment

You may not qualify if:

Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
History of drug-induced psoriasis
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
Concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab, adalimumab, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; or any other biologic agent \<5 half-lives prior to baseline
Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab 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, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
Have a known allergy or hypersensitivity to latex
Have had any major surgery within 8 weeks of baseline or will require such during the study
Have active or history of malignant disease within 5 years prior to baseline
Significant uncontrolled disorder
Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
Are women who are lactating or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (48)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Wein, 1090, Austria

Location

Brussels, 1200, Belgium

Location

Ghent, 9000, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Calgary, T3A 2N1, Canada

Location

Edmonton, T5K 1X3, Canada

Location

Mississauga, L5H 1GO, Canada

Location

North Bay, P1B 3Z7, Canada

Location

St. John's, A1A4Y3, Canada

Location

Toronto, M3H 5Y8, Canada

Location

Marseille, 13008, France

Location

Martigues, 13500, France

Location

Nice, 06202, France

Location

Rouen, 76031, France

Location

Toulouse, 31059, France

Location

Frankfurt am Main, 60590, Germany

Location

Giessen, 35390, Germany

Location

Hamburg, 20354, Germany

Location

Heidelberg, 69120, Germany

Location

Kiel, 24148, Germany

Location

Lübeck, 23538, Germany

Location

München, 80802, Germany

Location

Tübingen, 72076, Germany

Location

Witten, 58453, Germany

Location

Budapest, 1135, Hungary

Location

Kecskemét, 6000, Hungary

Location

Szeged, 6720, Hungary

Location

Szolnok, 5000, Hungary

Location

Catania, 95125, Italy

Location

Pisa, 56100, Italy

Location

Nijmegen, 6525 GL, Netherlands

Location

Bialystok, 15-351, Poland

Location

Lodz, 90-265, Poland

Location

Świdnik, 21-040, Poland

Location

Warsaw, 01-142, Poland

Location

Warsaw, 01-518, Poland

Location

Warsaw, 02-507, Poland

Location

Badalona, 08916, Spain

Location

Barcelona, 08041, Spain

Location

Madrid, 28031, Spain

Location

Madrid, 28041, Spain

Location

Seville, 41071, Spain

Location

Malmo, 20502, Sweden

Location

Stockholm, SE-118 83, Sweden

Location

Geneva, 1211, Switzerland

Location

Lausanne, 1011, Switzerland

Location

Zurich, 8091, Switzerland

Location

Dundee, DD1 9SY, United Kingdom

Location

Salford, M6 8HD, United Kingdom

Location

Related Publications (3)

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.
PMID: 38521874DERIVED
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.
PMID: 35279805DERIVED
Wasel N, Thaci D, French LE, Conrad C, Dutronc Y, Gallo G, Berggren L, Lacour JP. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020 Aug;10(4):663-670. doi: 10.1007/s13555-020-00383-x. Epub 2020 May 15.
PMID: 32415575DERIVED

MeSH Terms

Interventions

ixekizumabUstekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 25, 2015

First Posted

September 28, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

October 1, 2017

Last Updated

June 17, 2020

Results First Posted

February 28, 2018

Record last verified: 2020-06

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

HU(4)AU(1)BE(2)DE(9)PL(6)SE(2)CH(3)CA(6)ES(5)FR(5)NL(1)IT(2)GB(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (23)

Study Arms (2)

Ustekinumab

Ixekizumab

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (48)

Related Publications (3)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations