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

NCT03255382 | Completed Phase 3 Results

• 2 other identifiers: M16-1782016-003718-28
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 23

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.

Conditions

Psoriasis

Keywords

ABBV-0066; BI 655066; risankizumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24

  The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.

  Week 24

Secondary Outcomes (81)

• Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4

  Week 4

• Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8

  Week 8

• Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12

  Week 12

• Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16

  Week 16

• Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20

  Week 20

Study Arms (2)

Risankizumab

EXPERIMENTAL

Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.

Drug: risankizumab

Fumaderm

ACTIVE COMPARATOR

Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2 and then up to 240 mg, 3 times daily from Week 3 to Week 24 if 90% Improvement in Psoriasis Area and Severity Index (PASI90) is not achieved and if tolerability allows.

Drug: Fumaderm

Interventions

Fumaderm DRUG

Fumaderm tablet administered orally

Fumaderm

risankizumab DRUG

Risankizumab administered by subcutaneous (SC) injection

Also known as: ABBV-066, BI 655066, SKYRIZI

Risankizumab

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (23)

Universitaetsklinik Heidelberg /ID# 161014

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitaetsklinikum Erlangen /ID# 161035

Erlangen, Bavaria, 91054, Germany

Location

Universitatsklinikum Frankfurt /ID# 161036

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitatsklinikum Munster /ID# 165739

Munster, Lower Saxony, 48149, Germany

Location

Johannes Wesling Klin Minden /ID# 161015

Minden, North Rhine-Westphalia, 32429, Germany

Location

CMS3 Company for Medical Study /ID# 161103

Selters (Westerwald), Rhineland-Palatinate, 56242, Germany

Location

Univ Hosp Schleswig-Holstein /ID# 160995

Kiel, Schleswig-Holstein, 24105, Germany

Location

Medizinisches Versorgungszentrum DermaKiel GmbH /ID# 161102

Kiel, Schleswig-Holstein, 24148, Germany

Location

Charité Universitätsmedizin Campus Mitte /ID# 165621

Berlin, 10117, Germany

Location

ISA GmbH /ID# 165619

Berlin, 10789, Germany

Location

Gemeinschaftspraxis /ID# 161037

Blankenfeld-mahlow, 15831, Germany

Location

Hautzentrum Niesmann Othlingha /ID# 161034

Bochum, 44803, Germany

Location

Universitaetsklinikum Bonn /ID# 165618

Bonn, 53113, Germany

Location

Hautklinik Klinikum Darmstadt /ID# 164940

Darmstadt, 64297, Germany

Location

Universitaetklinikum Dresden /ID# 160983

Dresden, 01307, Germany

Location

Univ Klinik Eppendorf Hamburg /ID# 161038

Hamburg, 20246, Germany

Location

Tfs /Id# 160994

Hamburg, 20354, Germany

Location

Klinik fur Dermatologie /ID# 161101

Leipzig, 4103, Germany

Location

Univ Johannes Gutenberg /ID# 161104

Mainz, 55131, Germany

Location

TU Uniklinik Munchen /ID# 160996

Munich, 80802, Germany

Location

Universitatsklinikum Tubingen /ID# 165620

Tübingen, 72076, Germany

Location

Hoffmann, Witten, DE /ID# 165622

Witten, 58453, Germany

Location

Centroderm Wuppertal /ID# 165615

Wuppertal, 42287, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

Dimethyl Fumarate; risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 21, 2017
• Study Start: August 22, 2017
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08

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

DE (23)