Back to resultsA Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risankizumab
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0).
- Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits.
- Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global Assessment (sPGA) 2/3
- Participant must be eligible for continued biologic therapy as assessed by the investigator.
Exclusion Criteria:
- History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
- Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis.
- History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
- History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator.
- Participant with exposure to risankizumab or any IL-23 inhibitors.
- No known active SARS-CoV-2 infection. -- At least 14 days since first PCR test result have passed in asymptomatic participants or 14 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms.
Sites / Locations
- Alliance Dermatology and MOHs /ID# 216001
- Burke Pharmaceutical Research /ID# 225023
- Arkansas Research Trials /ID# 225497
- Bakersfield Derma & Skin Cance /ID# 213480
- UC Davis Health /ID# 225367
- CCD Research, PLLC /ID# 216062
- Florida International Rsrch cr /ID# 224983
- Advanced Medical Research /ID# 213484
- Arlington Dermatology /ID# 216000
- Dawes Fretzin, LLC /ID# 216004
- DermAssociates-Rockville /ID# 213837
- Cleaver Dermatology /ID# 226137
- Central Dermatology, PC /ID# 213479
- University Hospitals Case Medical Center /ID# 214795
- University of Pittsburgh MC /ID# 225644
- Clinical Partners, LLC /ID# 213836
- Arlington Research Center, Inc /ID# 215526
- Bellaire Dermatology /ID# 225486
- Modern Research Associates, PL /ID# 213835
- Menter Dermatology Res Inst /ID# 214002
- St George Dermatology & Skin Cancer Centre /ID# 213888
- Veracity Clinical Research /ID# 213889
- Skin Health Institute Inc /ID# 213886
- Fremantle Dermatology /ID# 213887
- Universitaetsklinikum Erlangen /ID# 214228
- Universitaetsklinikum Frankfurt /ID# 215889
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691
- Klinikum Ruhr Univ Bochum /ID# 225473
- Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469
- Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472
- Beldio Research GmbH /ID# 225471
- Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506
- The Chaim Sheba Medical Center /ID# 213815
- Tel Aviv Sourasky Medical Center /ID# 213812
- HaEmek Medical Center /ID# 214059
- Rabin Medical Center /ID# 213813
- Istituto Clinico Humanitas /ID# 214749
- IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745
- Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750
- Azienda Ospedaliero-Universitaria di Modena /ID# 214751
- AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752
- Hospital Universitario Germans Trias i Pujol /ID# 214031
- Hospital Universitario Fundacion Alcorcon /ID# 214033
- Hospital Parc de Salut del Mar /ID# 214034
- Hospital Puerta del Mar /ID# 214428
- Hospital Universitario La Paz /ID# 214341
- Hospital Universitario y Politecnico La Fe /ID# 214032
- Chung Shan Medical University Hospital /ID# 213634
- National Taiwan University Hospital /ID# 213630
- MacKay Memorial Hospital /ID# 213845
- Linkou Chang Gung Memorial Hospital /ID# 213631
- Victoria Hospital /ID# 213881
- Russells Hall Hospital, Dudley /ID# 213878
- Leeds Teaching Hospitals NHS Trust /ID# 213880
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877
- Northern Care Alliance NHS Group /ID# 213873
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Risankizumab
Arm Description
Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
Outcomes
Primary Outcome Measures
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Secondary Outcome Measures
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Proportion of Subjects Achieving a Dermatology Life Quality Index (DLQI) 0 or 1
The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are:
pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
Time to Achieve sPGA 0
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Percentage of Participants Achieving sPGA 0/1
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Percentage of Participants Achieving a sPGA 0
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Percentage of Participants Achieving a DLQI 0/1
The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status.
Percentage of Participants Achieving a PSS 0
The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms.
Time to Achieve sPGA 0/1
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04102007
Brief Title
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
Official Title
A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms.
Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risankizumab
Arm Type
Other
Arm Description
Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
SKYRIZI
Intervention Description
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Primary Outcome Measure Information:
Title
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
Description
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time Frame
At Week 16
Secondary Outcome Measure Information:
Title
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
Description
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time Frame
At Week 16
Title
Proportion of Subjects Achieving a Dermatology Life Quality Index (DLQI) 0 or 1
Description
The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
Time Frame
At Week 16
Title
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0
Description
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are:
pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
Time Frame
At Week 16
Title
Time to Achieve sPGA 0
Description
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Time Frame
Up to Week 52
Title
Percentage of Participants Achieving sPGA 0/1
Description
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Time Frame
At Week 52
Title
Percentage of Participants Achieving a sPGA 0
Description
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Time Frame
At Week 52
Title
Percentage of Participants Achieving a DLQI 0/1
Description
The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status.
Time Frame
At Week 52
Title
Percentage of Participants Achieving a PSS 0
Description
The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms.
Time Frame
At Week 52
Title
Time to Achieve sPGA 0/1
Description
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Time Frame
Up to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0).
Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits.
Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global Assessment (sPGA) 2/3
Participant must be eligible for continued biologic therapy as assessed by the investigator.
Exclusion Criteria:
History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis.
Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis.
History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator.
Participant with exposure to risankizumab or any IL-23 inhibitors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Alliance Dermatology and MOHs /ID# 216001
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Burke Pharmaceutical Research /ID# 225023
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913-6404
Country
United States
Facility Name
Arkansas Research Trials /ID# 225497
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Bakersfield Derma & Skin Cance /ID# 213480
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
UC Davis Health /ID# 225367
City
Sacramento
State/Province
California
ZIP/Postal Code
95816-3300
Country
United States
Facility Name
CCD Research, PLLC /ID# 216062
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416-1745
Country
United States
Facility Name
Florida International Rsrch cr /ID# 224983
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Advanced Medical Research /ID# 213484
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328-6141
Country
United States
Facility Name
Arlington Dermatology /ID# 216000
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Dawes Fretzin, LLC /ID# 216004
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
DermAssociates-Rockville /ID# 213837
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Cleaver Dermatology /ID# 226137
City
Kirksville
State/Province
Missouri
ZIP/Postal Code
63501-5362
Country
United States
Facility Name
Central Dermatology, PC /ID# 213479
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
University Hospitals Case Medical Center /ID# 214795
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Pittsburgh MC /ID# 225644
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Clinical Partners, LLC /ID# 213836
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Arlington Research Center, Inc /ID# 215526
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Bellaire Dermatology /ID# 225486
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Modern Research Associates, PL /ID# 213835
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Menter Dermatology Res Inst /ID# 214002
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
St George Dermatology & Skin Cancer Centre /ID# 213888
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Veracity Clinical Research /ID# 213889
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Skin Health Institute Inc /ID# 213886
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Fremantle Dermatology /ID# 213887
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Universitaetsklinikum Erlangen /ID# 214228
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 215889
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinikum Ruhr Univ Bochum /ID# 225473
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Beldio Research GmbH /ID# 225471
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
The Chaim Sheba Medical Center /ID# 213815
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 213812
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
HaEmek Medical Center /ID# 214059
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Rabin Medical Center /ID# 213813
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Istituto Clinico Humanitas /ID# 214749
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena /ID# 214751
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 214031
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Fundacion Alcorcon /ID# 214033
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Parc de Salut del Mar /ID# 214034
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Puerta del Mar /ID# 214428
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 214341
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 214032
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Chung Shan Medical University Hospital /ID# 213634
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 213630
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
MacKay Memorial Hospital /ID# 213845
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 213631
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Victoria Hospital /ID# 213881
City
Kirkcaldy
State/Province
Fife
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
Facility Name
Russells Hall Hospital, Dudley /ID# 213878
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust /ID# 213880
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Northern Care Alliance NHS Group /ID# 213873
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
https://www.rxabbvie.com/
Description
Related info
Learn more about this trial
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
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