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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02349295




Registration number
NCT02349295
Ethics application status
Date submitted
10/10/2014
Date registered
28/01/2015

Titles & IDs
Public title
A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Scientific 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
Secondary ID [1] 0 0
I1F-MC-RHBE
Secondary ID [2] 0 0
14310
Universal Trial Number (UTN)
Trial acronym
SPIRIT-P2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ixekizumab 80 mg Q4W
Treatment: Drugs - Ixekizumab 80 mg Q2W

Experimental: Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W) - 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).

Experimental: Ixekizumab 80 mg Q4W - 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).

Placebo comparator: Placebo - 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).


Treatment: Drugs: Placebo
Administered SC

Treatment: Drugs: Ixekizumab 80 mg Q4W
Administered SC

Treatment: Drugs: Ixekizumab 80 mg Q2W
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving ACR20
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Patients Achieving Minimal Disease Activity (MDA)
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Change From Baseline in Itch Numeric Rating Scale (NRS)
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
Change From Baseline in Tender Joint Count (TJC)
Timepoint [9] 0 0
Baseline, Week 24
Secondary outcome [10] 0 0
Change From Baseline in Swollen Joint Count (SJC)
Timepoint [10] 0 0
Baseline, Week 24
Secondary outcome [11] 0 0
Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)
Timepoint [11] 0 0
Baseline, Week 24
Secondary outcome [12] 0 0
Change From Baseline in Patients Global Assessment of Disease Activity VAS
Timepoint [12] 0 0
Baseline, Week 24
Secondary outcome [13] 0 0
Change From Baseline in Physicians Global Assessment of Disease Activity VAS
Timepoint [13] 0 0
Baseline, Week 24
Secondary outcome [14] 0 0
Change From Baseline in C-Reactive Protein (CRP)
Timepoint [14] 0 0
Baseline, Week 24
Secondary outcome [15] 0 0
Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)
Timepoint [15] 0 0
Baseline, Week 24
Secondary outcome [16] 0 0
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Timepoint [16] 0 0
Baseline, Week 24
Secondary outcome [17] 0 0
Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score
Timepoint [17] 0 0
Baseline, Week 24
Secondary outcome [18] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)
Timepoint [18] 0 0
Baseline, Week 24
Secondary outcome [19] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)
Timepoint [19] 0 0
Baseline, Week 24
Secondary outcome [20] 0 0
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Timepoint [20] 0 0
Week 24
Secondary outcome [21] 0 0
Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab
Timepoint [21] 0 0
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)
Secondary outcome [22] 0 0
Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab
Timepoint [22] 0 0
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)
Secondary outcome [23] 0 0
Percentage of Participants Achieving ACR 20
Timepoint [23] 0 0
Week 52 and Week 156
Secondary outcome [24] 0 0
Percentage of Participants Achieving ACR 50
Timepoint [24] 0 0
Week 52 and Week 156
Secondary outcome [25] 0 0
Percentage of Participants Achieving ACR 70
Timepoint [25] 0 0
Week 52 and Week 156

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/06/2019
Sample size
Target
Accrual to date
Final
363
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Coast Joint Care - Maroochydore
Recruitment hospital [3] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Montana
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Nebraska
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Washington
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Wisconsin
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Czechia
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Praha
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Czechia
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Uherske Hradiste
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Czechia
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Zlin
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France
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Chambray-lès-Tours
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France
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Montpellier Cedex 5
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France
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Nantes Cedex 1
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France
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Paris CEDEX 14
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France
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Toulouse
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France
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Vandoeuvre Les Nancy
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Germany
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Baden-Württemberg
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Bayern
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Germany
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Hessen
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Nordrhein-Westfalen
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Sachsen
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Milano
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Italy
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Pisa
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Poland
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Krakow
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Poznan
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Warszawa
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Andalucia
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Barcelona
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Cantabria
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Madrid
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Vizcaya
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La Coruña
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Spain
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Malaga
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Sevilla
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Taiwan
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Yongkang Dist
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Taiwan
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Kaohsiung City (r.o.c)
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Taipei
Country [64] 0 0
Taiwan
State/province [64] 0 0
Taoyuan City
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Essex
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Surrey
Country [67] 0 0
United Kingdom
State/province [67] 0 0
West Midlands
Country [68] 0 0
United Kingdom
State/province [68] 0 0
West Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02349295