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

NCT04102007 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M19-1642019-000904-14
• Study Type: interventional
• Target: 244
• Locations: 8 countries
• Sites: 57

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.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic

Outcome Measures

Primary Outcomes (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.

  At Week 16

Secondary Outcomes (9)

• Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)

  At Week 16

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

  At Week 16

• Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0

  At Week 16

• Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1

  At Week 52

• Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)

  At Week 52

Study Arms (1)

Risankizumab

OTHER

Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab

Drug: Risankizumab

Interventions

Risankizumab DRUG

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

Also known as: SKYRIZI

Risankizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (57)

Alliance Dermatology and MOHs /ID# 216001

Phoenix, Arizona, 85032, United States

Location

Burke Pharmaceutical Research /ID# 225023

Hot Springs, Arkansas, 71913-6404, United States

Location

Arkansas Research Trials /ID# 225497

North Little Rock, Arkansas, 72117, United States

Location

Bakersfield Derma & Skin Cance /ID# 213480

Bakersfield, California, 93309, United States

Location

UC Davis Health /ID# 225367

Sacramento, California, 95816-3300, United States

Location

CCD Research, PLLC /ID# 216062

Cromwell, Connecticut, 06416-1745, United States

Location

Florida International Rsrch cr /ID# 224983

Miami, Florida, 33173, United States

Location

Advanced Medical Research /ID# 213484

Sandy Springs, Georgia, 30328-6141, United States

Location

Arlington Dermatology /ID# 216000

Rolling Meadows, Illinois, 60008, United States

Location

Dawes Fretzin, LLC /ID# 216004

Indianapolis, Indiana, 46256, United States

Location

DermAssociates-Rockville /ID# 213837

Rockville, Maryland, 20850, United States

Location

Cleaver Dermatology /ID# 226137

Kirksville, Missouri, 63501-5362, United States

Location

Central Dermatology, PC /ID# 213479

St Louis, Missouri, 63117, United States

Location

University Hospitals Case Medical Center /ID# 214795

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh MC /ID# 225644

Pittsburgh, Pennsylvania, 15260, United States

Location

Clinical Partners, LLC /ID# 213836

Johnston, Rhode Island, 02919, United States

Location

Arlington Research Center, Inc /ID# 215526

Arlington, Texas, 76011, United States

Location

Bellaire Dermatology /ID# 225486

Bellaire, Texas, 77401, United States

Location

Modern Research Associates, PL /ID# 213835

Dallas, Texas, 75231, United States

Location

Menter Dermatology Res Inst /ID# 214002

Dallas, Texas, 75246, United States

Location

St George Dermatology & Skin Cancer Centre /ID# 213888

Kogarah, New South Wales, 2217, Australia

Location

Veracity Clinical Research /ID# 213889

Woolloongabba, Queensland, 4102, Australia

Location

Skin Health Institute Inc /ID# 213886

Carlton, Victoria, 3053, Australia

Location

Fremantle Dermatology /ID# 213887

Fremantle, Western Australia, 6160, Australia

Location

Universitaetsklinikum Erlangen /ID# 214228

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinikum Frankfurt /ID# 215889

Frankfurt am Main, Hesse, 60590, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691

Berlin, 10117, Germany

Location

Klinikum Ruhr Univ Bochum /ID# 225473

Bochum, 44791, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469

Lübeck, 23538, Germany

Location

Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472

Mahlow, 15831, Germany

Location

Beldio Research GmbH /ID# 225471

Memmingen, 87700, Germany

Location

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

Munich, 81675, Germany

Location

The Chaim Sheba Medical Center /ID# 213815

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 213812

Tel Aviv, Tel Aviv, 6423906, Israel

Location

HaEmek Medical Center /ID# 214059

Afula, 1834111, Israel

Location

Rabin Medical Center /ID# 213813

Petah Tikva, 4941492, Israel

Location

Istituto Clinico Humanitas /ID# 214749

Rozzano, Milano, 20089, Italy

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745

Bologna, 40138, Italy

Location

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

Cagliari, 09124, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750

Milan, 20122, Italy

Location

Azienda Ospedaliero-Universitaria di Modena /ID# 214751

Modena, 41124, Italy

Location

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

Napoli, 80138, Italy

Location

Hospital Universitario Germans Trias i Pujol /ID# 214031

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Fundacion Alcorcon /ID# 214033

Alcorcón, Madrid, 28922, Spain

Location

Hospital Parc de Salut del Mar /ID# 214034

Barcelona, 08003, Spain

Location

Hospital Puerta del Mar /ID# 214428

Cadiz, 11009, Spain

Location

Hospital Universitario La Paz /ID# 214341

Madrid, 28046, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 214032

Valencia, 46026, Spain

Location

Chung Shan Medical University Hospital /ID# 213634

Taichung, 40201, Taiwan

Location

National Taiwan University Hospital /ID# 213630

Taipei, 100, Taiwan

Location

MacKay Memorial Hospital /ID# 213845

Taipei, 10449, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 213631

Taoyuan, 333, Taiwan

Location

Victoria Hospital /ID# 213881

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

Russells Hall Hospital, Dudley /ID# 213878

Dudley, DY1 2HQ, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust /ID# 213880

Leeds, LS9 7TF, United Kingdom

Location

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

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Northern Care Alliance NHS Group /ID# 213873

Salford, M6 8HD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39516454 DERIVED

Related Links

• Related info

MeSH Terms

Interventions

risankizumab

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: November 12, 2019
• Primary Completion: January 17, 2022
• Study Completion: November 7, 2022
• Last Updated: November 27, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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.

Locations

AU (4); US (20); TW (4); GB (5); IT (6); DE (8); ES (6); IL (4)