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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102007
• Other study ID #: M19-164
• Secondary ID: 2019-000904-14
• Status: Completed
• Phase: Phase 3
• Start date: November 12, 2019
• Est. completion date: November 7, 2022

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: November 7, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Australia	Skin Health Institute Inc /ID# 213886	Carlton	Victoria
Australia	Fremantle Dermatology /ID# 213887	Fremantle	Western Australia
Australia	St George Dermatology & Skin Cancer Centre /ID# 213888	Kogarah	New South Wales
Australia	Veracity Clinical Research /ID# 213889	Woolloongabba	Queensland
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691	Berlin
Germany	Klinikum Ruhr Univ Bochum /ID# 225473	Bochum
Germany	Universitaetsklinikum Erlangen /ID# 214228	Erlangen	Bayern
Germany	Universitaetsklinikum Frankfurt /ID# 215889	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469	Luebeck
Germany	Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472	Mahlow
Germany	Beldio Research GmbH /ID# 225471	Memmingen
Germany	Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506	Munich
Israel	HaEmek Medical Center /ID# 214059	Afula
Israel	Rabin Medical Center /ID# 213813	Petakh Tikva
Israel	The Chaim Sheba Medical Center /ID# 213815	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 213812	Tel Aviv-Yafo	Tel-Aviv
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745	Bologna
Italy	Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748	Cagliari
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750	Milan
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 214751	Modena
Italy	AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752	Napoli
Italy	Istituto Clinico Humanitas /ID# 214749	Rozzano	Milano
Spain	Hospital Universitario Fundacion Alcorcon /ID# 214033	Alcorcon	Madrid
Spain	Hospital Universitario Germans Trias i Pujol /ID# 214031	Badalona	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 214034	Barcelona
Spain	Hospital Puerta del Mar /ID# 214428	Cadiz
Spain	Hospital Universitario La Paz /ID# 214341	Madrid
Spain	Hospital Universitario y Politecnico La Fe /ID# 214032	Valencia
Taiwan	Chung Shan Medical University Hospital /ID# 213634	Taichung
Taiwan	MacKay Memorial Hospital /ID# 213845	Taipei City
Taiwan	National Taiwan University Hospital /ID# 213630	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 213631	Taoyuan City
United Kingdom	Russells Hall Hospital, Dudley /ID# 213878	Dudley
United Kingdom	Victoria Hospital /ID# 213881	Kirkcaldy	Fife
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 213880	Leeds
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877	Newcastle Upon Tyne
United Kingdom	Northern Care Alliance NHS Group /ID# 213873	Salford
United States	Arlington Research Center, Inc /ID# 215526	Arlington	Texas
United States	Bakersfield Derma & Skin Cance /ID# 213480	Bakersfield	California
United States	Bellaire Dermatology /ID# 225486	Bellaire	Texas
United States	University Hospitals Case Medical Center /ID# 214795	Cleveland	Ohio
United States	CCD Research, PLLC /ID# 216062	Cromwell	Connecticut
United States	Menter Dermatology Res Inst /ID# 214002	Dallas	Texas
United States	Modern Research Associates, PL /ID# 213835	Dallas	Texas
United States	Burke Pharmaceutical Research /ID# 225023	Hot Springs	Arkansas
United States	Dawes Fretzin, LLC /ID# 216004	Indianapolis	Indiana
United States	Clinical Partners, LLC /ID# 213836	Johnston	Rhode Island
United States	Cleaver Dermatology /ID# 226137	Kirksville	Missouri
United States	Florida International Rsrch cr /ID# 224983	Miami	Florida
United States	Arkansas Research Trials /ID# 225497	North Little Rock	Arkansas
United States	Alliance Dermatology and MOHs /ID# 216001	Phoenix	Arizona
United States	University of Pittsburgh MC /ID# 225644	Pittsburgh	Pennsylvania
United States	DermAssociates-Rockville /ID# 213837	Rockville	Maryland
United States	Arlington Dermatology /ID# 216000	Rolling Meadows	Illinois
United States	UC Davis Health /ID# 225367	Sacramento	California
United States	Central Dermatology, PC /ID# 213479	Saint Louis	Missouri
United States	Advanced Medical Research /ID# 213484	Sandy Springs	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Israel,  Italy,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At Week 16
Secondary	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.	At Week 16
Secondary	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).	At Week 16
Secondary	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 52
Secondary	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.	At Week 52
Secondary	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.	At Week 52
Secondary	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).	At Week 52
Secondary	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.	Up to Week 52
Secondary	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.	Up to Week 52

External Links

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