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A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT-P2)

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Ixekizumab 80 mg Q4W

Ixekizumab 80 mg Q2W

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.

Exclusion Criteria:

Current use of biologic agents for treatment of Ps or PsA
Inadequate response to greater than 2 biologic DMARDs
Current use of more than one cDMARDs
Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
Serious disorder or illness other than psoriatic arthritis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)

Ixekizumab 80 mg Q4W

Placebo

Arm Description

Blinded Treatment Period (Week(wk) 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22, and 24.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Wks 16,18,20,22,24. Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q2W at week 0 and continued on ixe 80 mg Q2W during the Extension Period. Pts who received ixekizumab 80 mg Q2W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).

Blinded Treatment Period (Week 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q4W given on Wks 4, 8 and 12 alternating with placebo for ixe injections Q4W given on Wks 2,6,10,14,18, and 22.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Wks 16 and 20 alternating with placebo for ixe injections Q4W given on Wks 18 and 22.Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q4W at week 0 and continued on ixe 80 mg Q4W during the Extension Period.Pts who received ixekizumab 80 mg Q4W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).

Blinded Treatment Period (Wk 0-24): Pts received placebo for Ixe as 2 SC injections followed by 1 SC injection Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22 and 24. Pts initially randomized to placebo treatment group in the double blind treatment period,flagged as IR at Wk 16,re-randomized to ixe 80 mg Q2W/Q4W for the remainder of the current period and following period. Extended Treatment Period (Wk 24-156): Pts who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W/Q4W during the Extension Period.Pts who remained on placebo at the completion of the double blind treatment period received the first dose of ixe (160 mg starting dose) at Wk 24.Pts who were IRs at Wk 16 and were re-randomized to ixe at Wk 16 received the first dose of ixe (160 mg starting dose) at Wk 16. Pts who received placebo,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)

ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).

Secondary Outcome Measures

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.

Percentage of Participants Achieving ACR20

ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)

ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)

ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75

The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, 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 compared to their baseline measures.

Percentage of Patients Achieving Minimal Disease Activity (MDA)

It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1.

Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)

The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0" indicates good score here.

Change From Baseline in Itch Numeric Rating Scale (NRS)

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in Tender Joint Count (TJC)

TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in Swollen Joint Count (SJC)

SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)

The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in Patients Global Assessment of Disease Activity VAS

The patient's overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in Physicians Global Assessment of Disease Activity VAS

The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in C-Reactive Protein (CRP)

C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)

The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score

The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score

The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)

The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)

Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)

Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.

Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab

The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.

Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab

The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).

Percentage of Participants Achieving ACR 20

Percentage of Participants Achieving ACR 50

Percentage of Participants Achieving ACR 70

Full Information

NCT ID

NCT02349295

First Posted

October 10, 2014

Last Updated

June 19, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02349295

Brief Title

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Acronym

SPIRIT-P2

Official Title

A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

September 1, 2019

Overall Recruitment Status

Completed

Study Start Date

December 31, 2014 (Actual)

Primary Completion Date

September 9, 2016 (Actual)

Study Completion Date

June 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

363 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)

Arm Type

Experimental

Arm Description

Arm Title

Ixekizumab 80 mg Q4W

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Ixekizumab 80 mg Q4W

Other Intervention Name(s)

LY2439821

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Ixekizumab 80 mg Q2W

Other Intervention Name(s)

LY2439821

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

Description

Time Frame

Baseline, Week 24

Title

Percentage of Participants Achieving ACR20

Description

Time Frame

Week 12

Title

Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)

Description

Time Frame

Week 24

Title

Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)

Description

Time Frame

Week 24

Title

Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75

Description

Time Frame

Week 12

Title

Percentage of Patients Achieving Minimal Disease Activity (MDA)

Description

Time Frame

Week 24

Title

Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)

Description

Time Frame

Week 24

Title

Change From Baseline in Itch Numeric Rating Scale (NRS)

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Tender Joint Count (TJC)

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Swollen Joint Count (SJC)

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Patients Global Assessment of Disease Activity VAS

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Physicians Global Assessment of Disease Activity VAS

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in C-Reactive Protein (CRP)

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)

Description

Time Frame

Baseline, Week 24

Title

Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)

Description

Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.

Time Frame

Week 24

Title

Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab

Description

The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.

Time Frame

All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)

Title

Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab

Description

Time Frame

Title

Percentage of Participants Achieving ACR 20

Description

Time Frame

Week 52 and Week 156

Title

Percentage of Participants Achieving ACR 50

Description

Time Frame

Week 52 and Week 156

Title

Percentage of Participants Achieving ACR 70

Description

Time Frame

Week 52 and Week 156

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps) Men must agree to use a reliable method of birth control or remain abstinent during the study Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs) Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance. Exclusion Criteria: Current use of biologic agents for treatment of Ps or PsA Inadequate response to greater than 2 biologic DMARDs Current use of more than one cDMARDs Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy Serious disorder or illness other than psoriatic arthritis Serious infection within the last 3 months Breastfeeding or nursing (lactating) women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Rheumatology Associates PC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Research

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85304

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Research, PLLC

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Research

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Little Rock Diagnostic Clinic

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

University of California - San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Purushotham & Akther Kotha MD Inc

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Stanford University Hospital

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

East Bay Rheumatology Medical Group

City

San Leandro

State/Province

California

ZIP/Postal Code

94578

Country

United States

Facility Name

Office: Dr Robin K Dore

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Rheumatology Associates of South Florida

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Jeffrey Alper MD Research

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Arthritis & Osteoporosis Treatment Center, PA

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Florida Medical Clinic PA

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542-7505

Country

United States

Facility Name

Diagnostic Rheumatology and Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

Physicians Clinic of Iowa

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52403

Country

United States

Facility Name

Heartland Research Associates

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Bluegrass Community Research. Inc

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Johns Hopkins Arthritis Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Klein and Associates MD, PA

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Klein and Associates MD, PA

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Beals Institute PC

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48917

Country

United States

Facility Name

North MS Medical Clinics, Inc.

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Glacier View Research Institute

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

Physician Research Collaboration, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

New Jersey Physicians

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012

Country

United States

Facility Name

Atlantic Coastal Research

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Arthritis, Rheumatic & Back Disease Associates

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Albuquerque Rehabilitation & Rheumatology, PC

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

The Center for Rheumatology

City

Albany

State/Province

New York

ZIP/Postal Code

12203

Country

United States

Facility Name

Weill Cornell Medical College

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

Allergy Asthma Immunology of Rochester, AAIR Research Ctr

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Rheumatology Associates of Long Island

City

Smithtown

State/Province

New York

ZIP/Postal Code

11787

Country

United States

Facility Name

Arthritis and Osteoporosis Consultants of the Carolinas

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

DJL Clinical Research, PLLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

PMG Research of Hickory, LLC

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

STAT Research

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Health Research Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

PMA Medical Specialists, LLC

City

Limerick

State/Province

Pennsylvania

ZIP/Postal Code

19468

Country

United States

Facility Name

Clinical Research Center of Reading, LLC

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Pennsylvania Regional Center for Arthritis & Osteoarthritis

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Methodist Healthcare

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104-3499

Country

United States

Facility Name

Ramesh C. Gupta MD

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Austin Rheumatology Research PA

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Austin Regional Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Arthritis Care & Diagnostic Center P.A.

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Pioneer Research Solutions

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

Houston Institute for Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Accurate Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

Accurate Clinical Research

City

League City

State/Province

Texas

ZIP/Postal Code

77573

Country

United States

Facility Name

Arthritis & Osteoporosis Associates LLP

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

Country

United States

Facility Name

Kadlec Clinic Rheumatology

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

Swedish Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Arthritis Northwest PLLC

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Rheumatology and Immunotherapy Center

City

Franklin

State/Province

Wisconsin

ZIP/Postal Code

53132

Country

United States

Facility Name

Royal Prince Alfred Hospital

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Coast Joint Care

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Emeritus Research

City

Camberwell

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

Facility Name

CCBR Czech Prague, s.r.o.

City

Praha

ZIP/Postal Code

13000

Country

Czechia

Facility Name

MEDICAL PLUS, s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

PV-MEDICAL s.r.o. Revmatologicka ambulance

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Hôpital Trousseau, CHRU de Tours

City

Chambray-lès-Tours

ZIP/Postal Code

37170

Country

France

Facility Name

CHU de Montpellier-Hopital Arnaud de Villeneuve

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Chru De Nantes Hotel-Dieu

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Hopital Cochin

City

Paris CEDEX 14

ZIP/Postal Code

75679

Country

France

Facility Name

Hopital Purpan

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

CHU Brabois

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Universitätsklinikum Heidelberg

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitätsklinikum Würzburg

City

Würzburg

State/Province

Bayern

ZIP/Postal Code

97080

Country

Germany

Facility Name

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Rheumazentrum Ruhrgebiet

City

Herne

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44649

Country

Germany

Facility Name

Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01067

Country

Germany

Facility Name

Universitätsklinikum Carl Gustav Carus

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universität Leipzig - Universitätsklinikum

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Universitätsklinikum Schleswig-Holstein

City

Lübeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

Charité Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

HRF Hamburger Rheuma Forschungszentrum

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

Istituto Ortopedico Gaetano Pini

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Azienda Ospedaliera - Universitaria Pisana

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Malopolskie Centrum Medyczne S.C.

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Medica pro Familia Sp z o.o. S.K.A

City

Krakow

ZIP/Postal Code

30002

Country

Poland

Facility Name

AI Centrum Medyczne

City

Poznan

ZIP/Postal Code

61-113

Country

Poland

Facility Name

Medica pro Familia Sp z o.o. S.K.A

City

Warszawa

ZIP/Postal Code

01-868

Country

Poland

Facility Name

Rheuma Medicus Zakład Opieki Zdrowotnej

City

Warszawa

ZIP/Postal Code

02-118

Country

Poland

Facility Name

Hospital Infanta Luisa

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41007

Country

Spain

Facility Name

Centro de Salud Mental Parc Tauli

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Universitario Marques De Valdecilla

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital De Fuenlabrada

City

Fuenlabrada

State/Province

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Hospital De Basurto

City

Bilbao

State/Province

Vizcaya

ZIP/Postal Code

48013

Country

Spain

Facility Name

Complexo Hospitalario Universitario A Coruña, CHUAC

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Regional Universitario de Málaga

City

Malaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Hospital Universitario Nuestra Señora de Valme

City

Sevilla

ZIP/Postal Code

46014

Country

Spain

Facility Name

Chi-Mei Hospital, Liouying

City

Tainan City

State/Province

Yongkang Dist

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Kaohsiung

City

Kaohsiung City (r.o.c)

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung City

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Linkou

City

Taoyuan City

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Basildon and Thurrock University Hospital

City

Basildon

State/Province

Essex

ZIP/Postal Code

SS16 5NL

Country

United Kingdom

Facility Name

King George Hospital

City

Goodmayes

State/Province

Essex

ZIP/Postal Code

IG7 4DY

Country

United Kingdom

Facility Name

Princess Alexandra Hospital

City

Harlow

State/Province

Essex

ZIP/Postal Code

CM20 1QX

Country

United Kingdom

Facility Name

Whipps Cross University Hospital

City

London

State/Province

Surrey

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

New Cross Hospital

City

Wolverhampton

State/Province

West Midlands

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

Facility Name

Chapel Allerton Hospital

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

35397092

Citation

Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.

Results Reference

derived

PubMed Identifier

35393269

Citation

Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

Results Reference

derived

PubMed Identifier

33499913

Citation

Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

Results Reference

derived

PubMed Identifier

33278016

Citation

Orbai AM, Gratacos J, Turkiewicz A, Hall S, Dokoupilova E, Combe B, Nash P, Gallo G, Bertram CC, Gellett AM, Sprabery AT, Birt J, Macpherson L, Geneus VJ, Constantin A. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021 Mar;8(1):199-217. doi: 10.1007/s40744-020-00261-0. Epub 2020 Dec 5.

Results Reference

derived

PubMed Identifier

32792421

Citation

Schweikert B, Malmberg C, Nunez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

Results Reference

derived

PubMed Identifier

31964419

Citation

Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

Results Reference

derived

PubMed Identifier

31154634

Citation

Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

Results Reference

derived

PubMed Identifier

30886974

Citation

Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

Results Reference

derived

PubMed Identifier

30696483

Citation

Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

Results Reference

derived

PubMed Identifier

30053162

Citation

Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018 Nov 1;57(11):2001-2011. doi: 10.1093/rheumatology/key182.

Results Reference

derived

PubMed Identifier

28551073

Citation

Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.

Results Reference

derived

Learn more about this trial

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

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A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT-P2)

Psoriatic Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial