A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: Placebo solution for risankizumab; Drug: Risankizumab

• Registration Number: NCT03875482
• Lead Sponsor: AbbVie

Brief Summary

The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

Detailed Description

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Study Start: 2019-05-13
• Primary Completion: 2020-02-20
• Study Completion: 2020-07-15
• Status Verified: 2021-02
• Results First Submitted: 2021-02-19
• Results First Submitted QC: 2021-02-19
• Last Update Submitted: 2021-02-19
• Results First Posted: 2021-03-16
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• 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 greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
• Candidate for systemic therapy as assessed by the investigator.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo solution for risankizumab	Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
Risankizumab	Risankizumab	Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16	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. 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 Week 16) / PASI score at Baseline \* 100.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16	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. PASI100 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.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16	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.

Trial Locations

Locations (43)

Anaheim Clinical Trials LLC /ID# 212559; 🇺🇸 Anaheim, California, United States

Skin Laser and Surgery Specialists of NY and NJ /ID# 210208; 🇺🇸 Hackensack, New Jersey, United States

Arlington Research Center, Inc /ID# 210344; 🇺🇸 Arlington, Texas, United States

Progressive Clinical Research /ID# 210359; 🇺🇸 San Antonio, Texas, United States

Total Skin and Beauty Derm Ctr /ID# 210366; 🇺🇸 Birmingham, Alabama, United States

Lynn Health Science Institute (LHSI) /ID# 213216; 🇺🇸 Oklahoma City, Oklahoma, United States

Ormond Medical Arts Pharmaceutical Research Center /ID# 212781; 🇺🇸 Ormond Beach, Florida, United States

Alliance Dermatology and MOHs /ID# 210645; 🇺🇸 Phoenix, Arizona, United States

Suncoast Clinical Research /ID# 210874; 🇺🇸 New Port Richey, Florida, United States

Dermatology Res. Assoc., CA /ID# 210402; 🇺🇸 Los Angeles, California, United States

Hull Dermatology, PA /ID# 210305; 🇺🇸 Rogers, Arkansas, United States

Mosaic Dermatology /ID# 210780; 🇺🇸 Santa Monica, California, United States

Skin Care Research, LLC /ID# 210514; 🇺🇸 Boca Raton, Florida, United States

Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562; 🇺🇸 Normal, Illinois, United States

Clinical Partners, LLC /ID# 210642; 🇺🇸 Johnston, Rhode Island, United States

Forefront Dermatology /ID# 210520; 🇺🇸 Louisville, Kentucky, United States

Advanced Dermatology of the Midlands /ID# 212763; 🇺🇸 Omaha, Nebraska, United States

Lenus Research & Medical Group /ID# 212584; 🇺🇸 Sweetwater, Florida, United States

Treasure Valley Dermatology /ID# 212707; 🇺🇸 Boise, Idaho, United States

Progressive Medical Research /ID# 210877; 🇺🇸 Port Orange, Florida, United States

The Indiana Clinical Trials Center /ID# 210205; 🇺🇸 Plainfield, Indiana, United States

Palmetto Clinical Trial Services /ID# 210368; 🇺🇸 Fountain Inn, South Carolina, United States

Dr. Samuel Sanchez, PSC /ID# 211142; 🇵🇷 Caguas, Puerto Rico

Clinical Research Puerto Rico /ID# 211144; 🇵🇷 San Juan, Puerto Rico

Coastal Carolina Research Ctr /ID# 213069; 🇺🇸 Mount Pleasant, South Carolina, United States

Pan American Center for Oncology Trials, LLC /ID# 212445; 🇵🇷 Rio Piedras, Puerto Rico

WDC Cosmetic and Research, PLLC /ID# 210372; 🇺🇸 Wilmington, North Carolina, United States

Center for Clinical Studies - Houston (Binz) /ID# 210361; 🇺🇸 Houston, Texas, United States

Acclaim Dermatology /ID# 212252; 🇺🇸 Sugar Land, Texas, United States

David Fivenson, MD, PLC /ID# 210193; 🇺🇸 Ann Arbor, Michigan, United States

Clarkston Skin Research /ID# 210197; 🇺🇸 Clarkston, Michigan, United States

Skin Specialists, PC /ID# 211490; 🇺🇸 Omaha, Nebraska, United States

Integrative Skin Science and Research /ID# 212551; 🇺🇸 Sacramento, California, United States

Precision Clinical Research /ID# 212921; 🇺🇸 Sunrise, Florida, United States

Multi-Speciality Research Associates /ID# 211625; 🇺🇸 Lake City, Florida, United States

ACCEL Research Sites /ID# 212709; 🇺🇸 DeLand, Florida, United States

GSI Clinical Research, LLC /ID# 210330; 🇺🇸 Margate, Florida, United States

DermResearchCenter of NY, Inc. /ID# 210652; 🇺🇸 Stony Brook, New York, United States

DS Research /ID# 210272; 🇺🇸 Louisville, Kentucky, United States

Cleaver Dermatology /ID# 210300; 🇺🇸 Kirksville, Missouri, United States

Henry Ford Medical Center /ID# 211598; 🇺🇸 Detroit, Michigan, United States

Psoriasis Treatment Ctr NJ /ID# 210837; 🇺🇸 East Windsor, New Jersey, United States

Wallace Medical Group, Inc. /ID# 210403; 🇺🇸 Beverly Hills, California, United States