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Plaque PsoriasisPhase 3NCT04102007

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

A Phase 3 study testing Risankizumab in people with Plaque Psoriasis, run by AbbVie at 57 sites in 8 countries.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
57 sitesin 8 countries
Study dates
12 Nov 2019to 7 Nov 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

57 sites in 8 countries.

57 sites in 8 countries

United States20 sites

  • Arlington Research Center, Inc /ID# 215526

    Arlington, Texas, 76011

  • Bakersfield Derma & Skin Cance /ID# 213480

    Bakersfield, California, 93309

  • Bellaire Dermatology /ID# 225486

    Bellaire, Texas, 77401

  • University Hospitals Case Medical Center /ID# 214795

    Cleveland, Ohio, 44106

  • CCD Research, PLLC /ID# 216062

    Cromwell, Connecticut, 06416-1745

  • Modern Research Associates, PL /ID# 213835

    Dallas, Texas, 75231

  • Menter Dermatology Res Inst /ID# 214002

    Dallas, Texas, 75246

  • Burke Pharmaceutical Research /ID# 225023

    Hot Springs, Arkansas, 71913-6404

  • Dawes Fretzin, LLC /ID# 216004

    Indianapolis, Indiana, 46256

  • Clinical Partners, LLC /ID# 213836

    Johnston, Rhode Island, 02919

  • Cleaver Dermatology /ID# 226137

    Kirksville, Missouri, 63501-5362

  • Florida International Rsrch cr /ID# 224983

    Miami, Florida, 33173

  • Arkansas Research Trials /ID# 225497

    North Little Rock, Arkansas, 72117

  • Alliance Dermatology and MOHs /ID# 216001

    Phoenix, Arizona, 85032

  • University of Pittsburgh MC /ID# 225644

    Pittsburgh, Pennsylvania, 15260

  • DermAssociates-Rockville /ID# 213837

    Rockville, Maryland, 20850

  • Arlington Dermatology /ID# 216000

    Rolling Meadows, Illinois, 60008

  • UC Davis Health /ID# 225367

    Sacramento, California, 95816-3300

  • Advanced Medical Research /ID# 213484

    Sandy Springs, Georgia, 30328-6141

  • Central Dermatology, PC /ID# 213479

    St Louis, Missouri, 63117

Other trials in United States

Germany8 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691

    Berlin, 10117

  • Klinikum Ruhr Univ Bochum /ID# 225473

    Bochum, 44791

  • Universitaetsklinikum Erlangen /ID# 214228

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Frankfurt /ID# 215889

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469

    Lübeck, 23538

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472

    Mahlow, 15831

  • Beldio Research GmbH /ID# 225471

    Memmingen, 87700

  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506

    Munich, 81675

Other trials in Germany

Italy6 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745

    Bologna, 40138

  • Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748

    Cagliari, 09124

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750

    Milan, 20122

  • Azienda Ospedaliero-Universitaria di Modena /ID# 214751

    Modena, 41124

  • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752

    Naples, 80138

  • Istituto Clinico Humanitas /ID# 214749

    Rozzano, Milano, 20089

Other trials in Italy

Spain6 sites

  • Hospital Universitario Fundacion Alcorcon /ID# 214033

    Alcorcón, Madrid, 28922

  • Hospital Universitario Germans Trias i Pujol /ID# 214031

    Badalona, Barcelona, 08916

  • Hospital Parc de Salut del Mar /ID# 214034

    Barcelona, 08003

  • Hospital Puerta del Mar /ID# 214428

    Cadiz, 11009

  • Hospital Universitario La Paz /ID# 214341

    Madrid, 28046

  • Hospital Universitario y Politecnico La Fe /ID# 214032

    Valencia, 46026

Other trials in Spain

United Kingdom5 sites

  • Russells Hall Hospital, Dudley /ID# 213878

    Dudley, DY1 2HQ

  • Victoria Hospital /ID# 213881

    Kirkcaldy, Fife, KY2 5AH

  • Leeds Teaching Hospitals NHS Trust /ID# 213880

    Leeds, LS9 7TF

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877

    Newcastle upon Tyne, NE7 7DN

  • Northern Care Alliance NHS Group /ID# 213873

    Salford, M6 8HD

Other trials in United Kingdom

Australia4 sites

  • Skin Health Institute Inc /ID# 213886

    Carlton, Victoria, 3053

  • Fremantle Dermatology /ID# 213887

    Fremantle, Western Australia, 6160

  • St George Dermatology & Skin Cancer Centre /ID# 213888

    Kogarah, New South Wales, 2217

  • Veracity Clinical Research /ID# 213889

    Woolloongabba, Queensland, 4102

Other trials in Australia

Israel4 sites

  • HaEmek Medical Center /ID# 214059

    Afula, 1834111

  • Rabin Medical Center /ID# 213813

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 213815

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 213812

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Taiwan4 sites

  • Chung Shan Medical University Hospital /ID# 213634

    Taichung, 40201

  • National Taiwan University Hospital /ID# 213630

    Taipei, 100

  • MacKay Memorial Hospital /ID# 213845

    Taipei, 10449

  • Linkou Chang Gung Memorial Hospital /ID# 213631

    Taoyuan City, 333

Other trials in Taiwan

About this study

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

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.

Being tested
Risankizumab
Keywords
Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic

What participants receive

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

  • RisankizumabDrug

    Also called SKYRIZI

    Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).

Study groups in NCT04102007
Study groupRoleWhat they receive
RisankizumabOtherParticipants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
Receives: Drug: Risankizumab

What is being measured

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

  1. 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.

    Measured: At Week 16

Secondary outcomes (9)

  1. 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.

    Measured: At Week 16

  2. Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1

    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.

    Measured: At Week 16

  3. 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).

    Measured: At Week 16

  4. 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.

    Measured: At Week 52

  5. 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.

    Measured: At Week 52

  6. Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1

    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.

    Measured: At Week 52

  7. Proportion of Participants Achieving a 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).

    Measured: At Week 52

  8. Time to Achieve 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.

    Measured: Up to Week 52

  9. Time to Achieve 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.

    Measured: Up to Week 52

Timeline

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

  1. First posted25 Sep 2019
  2. Study start12 Nov 2019
  3. Primary completion17 Jan 2022
  4. Study completion7 Nov 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04102007
Sponsor's protocol ID
M19-164
Other IDs
2019-000904-14, 2019
Status last verified
Nov 2023
First submitted
23 Sep 2019
Last updated
27 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Warren RB, Pavlovsky L, Costanzo A, Bukhalo M, Korman NJ, Huang YH, Kokolakis G, Pinter A, Ibrahim N, Zheng Y, Drogaris L, Stakias V, Soliman AM, Rubant S, Thaci D. Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study. Dermatol Ther (Heidelb). 2024 Dec;14(12):3273-3290. doi: 10.1007/s13555-024-01292-z. Epub 2024 Nov 8.

    PubMed 39516454

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab in people with Plaque Psoriasis, run by AbbVie at 57 sites in 8 countries.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Germany, Italy, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 (time frame: At Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04102007, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.

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