A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

NCT03875508 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: M16-005
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 26

Brief Summary

The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.

Conditions

Psoriasis

Keywords

Psoriasis; Risankizumab; Plaque Psoriasis

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With an Observer Rating of Successful Participant Self-administration

  Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection".

  Day 1 and Week 28

• Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16

  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. PASI 90 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 Week 16) / PASI score at Baseline \* 100.

  At Week 16

• Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16

  The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5.

  At Week 16

• Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16

  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. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline \* 100.

  At Week 16

• Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16

  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. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline \* 100.

  At Week 16

• Percentage of Participants Who Had No Potential Hazards as Measured by an Observer

  Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others.

  Day 1 and Week 28

• Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)

  Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector.

  Day 1, Week 4, Week 16, Week 28

Other Outcomes (1)

• Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16

  Baseline, Week 4, and Week 16

Study Arms (1)

Risankizumab

EXPERIMENTAL

Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28

Drug: Risankizumab; Device: Autoinjector

Interventions

Risankizumab DRUG

Risankizumab to be injected subcutaneously (SC)

Also known as: ABBV-066, BI 655066

Risankizumab

Autoinjector DEVICE

Single dose pre-filled autoinjector containing risankizumab for SC injection

Risankizumab

Eligibility Criteria

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

You may qualify if:

• Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit
• Participant meets following disease activity criteria:
• Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baseline visit
• Candidate for systemic therapy as assessed by the investigator

You may not qualify if:

• Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis
• Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
• Participant has previous exposure to risankizumab

Sponsors & Collaborators

• AbbVie: lead

Study Sites (26)

Advanced Research Associates /ID# 210634

Glendale, Arizona, 85308, United States

Location

Cognitive Clinical Trials /ID# 210770

Scottsdale, Arizona, 85258-4446, United States

Location

Burke Pharmaceutical Research /ID# 211386

Hot Springs, Arkansas, 71913-6404, United States

Location

Bakersfield Derma & Skin Cance /ID# 210773

Bakersfield, California, 93309, United States

Location

Encino Research Center / T. Jo /ID# 211735

Encino, California, 91436, United States

Location

Tien Q Nguyen MD, Inc /ID# 210775

Fountain Valley, California, 92708-3701, United States

Location

UC Davis Health /ID# 210411

Sacramento, California, 95816, United States

Location

Dermatology Physicians of CT /ID# 210637

Shelton, Connecticut, 06484-6211, United States

Location

Florida Academic Centers Research /ID# 210337

Coral Gables, Florida, 33134, United States

Location

Medallion Clinical Research Institute, LLC /ID# 210329

Naples, Florida, 34102, United States

Location

Renstar Medical Research /ID# 210878

Ocala, Florida, 34470, United States

Location

Epiphany Dermatology /ID# 211493

Overland Park, Kansas, 66215, United States

Location

DermAssociates /ID# 210838

Rockville, Maryland, 20850, United States

Location

Great Lakes Research, Inc. /ID# 210192

Bay City, Michigan, 48602, United States

Location

Somerset Skin Centre /ID# 211596

Troy, Michigan, 48084, United States

Location

Central Dermatology, PC /ID# 210301

St Louis, Missouri, 63117, United States

Location

AllCutis Research Inc /ID# 211429

Portsmouth, New Hampshire, 03801, United States

Location

Medication Management, LLC /ID# 213217

Greensboro, North Carolina, 27408, United States

Location

Oregon Medical Res Center PC /ID# 210334

Portland, Oregon, 97223, United States

Location

University of Pittsburgh MC /ID# 210839

Pittsburgh, Pennsylvania, 15260, United States

Location

Center for Clinical Studies /ID# 211565

Cypress, Texas, 77433, United States

Location

Center for Clinical Studies /ID# 210362

Houston, Texas, 77004, United States

Location

Suzanne Bruce and Associates /ID# 212210

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research /ID# 212203

Pflugerville, Texas, 78660, United States

Location

Premier Clinical Research /ID# 212209

Spokane, Washington, 99202, United States

Location

Froedtert Mem Lutheran Hosp /ID# 210194

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

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

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: March 13, 2019
• First Posted: March 14, 2019
• Study Start: June 4, 2019
• Primary Completion: April 24, 2020
• Study Completion: August 25, 2020
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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

US (26)