Clinical trial NCT03255382: A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
Official title: A Randomized, Controlled, Multicenter, Open Label Study With Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: ABBV-0066
BI 655066
risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.

Detailed description: The efficacy analysis was performed in the Intent to Treat (ITT) set which included all participants who were randomized. The safety analysis was performed in the safety set which included all participants who received at least one dose of study drug. No participants were excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued after randomization prior to receiving any study drug and were thus not included in the safety set.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant
* Participant has stable moderate to severe plaque psoriasis (body surface area \[BSA\] \>10, Psoriasis Area and Severity Index \[PASI\] \>10, and Dermatology Quality of Life Index \[DLQI\] \>10) with or without psoriatic arthritis at Baseline
* Must be naïve to and candidate for systemic therapy, as assessed by the investigator
* Participant has an inadequate response, intolerance or contraindication to topical psoriasis treatment

Exclusion Criteria:

* Participants with non-plaque forms of psoriasis
* Participant has previously received systemic therapy for psoriasis, whether biologic or non-biologic or photochemotherapy
* Active systemic infection during the last 2 weeks (exception: common cold) prior to screening.
* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
* Participant has any condition or contraindication to Fumaderm that would preclude the patient's participation in the present study

Primary outcomes:
measure: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20
timeFrame: Week 20
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20
timeFrame: Week 20
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20
timeFrame: Week 20
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20
timeFrame: Week 20
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24
timeFrame: Week 24
measure: Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4
timeFrame: Baseline, Week 4
measure: PASI: Change From Baseline to Week 8
timeFrame: Baseline, Week 8
measure: PASI: Change From Baseline to Week 12
timeFrame: Baseline, Week 12
measure: PASI: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: PASI: Change From Baseline to Week 20
timeFrame: Baseline, Week 20
measure: PASI: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20
timeFrame: Week 20
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 20
timeFrame: Week 20
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16
timeFrame: Week 16
measure: Percentage of Participants With PSS Score of 0 at Week 24
timeFrame: Week 24
measure: PSS Total Score: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: PSS Total Score: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Summary of Patient Benefit Index (PBI) at Week 16
timeFrame: Baseline, Week 16
measure: Summary of PBI at Week 24
timeFrame: Baseline Week 24
measure: Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: NAPPA-CLIN Total Score: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: PPASI: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4
timeFrame: Baseline, Week 4
measure: BSA Affected by Psoriasis: Change From Baseline to Week 8
timeFrame: Baseline, Week 8
measure: BSA Affected by Psoriasis: Change From Baseline to Week 12
timeFrame: Baseline, Week 12
measure: BSA Affected by Psoriasis: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: BSA Affected by Psoriasis: Change From Baseline to Week 20
timeFrame: Baseline, Week 20
measure: BSA Affected by Psoriasis: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: SF-36 V2 PCS Score: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16
timeFrame: Baseline, Week 16
measure: SF-36 V2 MCS Score: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Patient's Global Assessment (PtGA): Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: PtGA: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: HADS Total Score-Anxiety: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: HADS Total Score-Depression: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: HADS Total Score-Depression: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24
timeFrame: Week 24
measure: DLQI Total Score: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: DLQI: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16
timeFrame: Baseline, Week 16
measure: PSSI: Change From Baseline at Week 24
timeFrame: Baseline, Week 24
measure: European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: EQ-5D-5L Total Score: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: EQ-5D-5L VAS: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: NAPSI: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg /ID# 161014
state: Baden-Wuerttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 161035
state: Bayern
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt /ID# 161036
state: Hessen
city: Munster
country: Germany
facility: Universitatsklinikum Munster /ID# 165739
state: Niedersachsen
city: Minden
country: Germany
facility: Johannes Wesling Klin Minden /ID# 161015
state: Nordrhein-Westfalen
city: Selters (Westerwald)
country: Germany
facility: CMS3 Company for Medical Study /ID# 161103
state: Rheinland-Pfalz
city: Kiel
country: Germany
facility: Univ Hosp Schleswig-Holstein /ID# 160995
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Medizinisches Versorgungszentrum DermaKiel GmbH /ID# 161102
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Campus Mitte /ID# 165621
city: Berlin
country: Germany
facility: ISA GmbH /ID# 165619
city: Blankenfeld-mahlow
country: Germany
facility: Gemeinschaftspraxis /ID# 161037
city: Bochum
country: Germany
facility: Hautzentrum Niesmann Othlingha /ID# 161034
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn /ID# 165618
city: Darmstadt
country: Germany
facility: Hautklinik Klinikum Darmstadt /ID# 164940
city: Dresden
country: Germany
facility: Universitaetklinikum Dresden /ID# 160983
city: Hamburg
country: Germany
facility: Univ Klinik Eppendorf Hamburg /ID# 161038
city: Hamburg
country: Germany
facility: Tfs /Id# 160994
city: Leipzig
country: Germany
facility: Klinik fur Dermatologie /ID# 161101
city: Mainz
country: Germany
facility: Univ Johannes Gutenberg /ID# 161104
city: Munich
country: Germany
facility: TU Uniklinik Munchen /ID# 160996
city: Tuebingen
country: Germany
facility: Universitatsklinikum Tubingen /ID# 165620
city: Witten
country: Germany
facility: Hoffmann, Witten, DE /ID# 165622
city: Wuppertal
country: Germany
facility: Centroderm Wuppertal /ID# 165615
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: