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

Psoriasis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875482
• Other study ID #: M15-999
• Status: Completed
• Phase: Phase 3
• Start date: May 13, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: February 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: July 15, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Risankizumab
Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously
• Placebo solution for risankizumab
Placebo solution in prefilled syringes, self-administered subcutaneously

Locations

Country	Name	City	State
Puerto Rico	Dr. Samuel Sanchez, PSC /ID# 211142	Caguas
Puerto Rico	Pan American Center for Oncology Trials, LLC /ID# 212445	Rio Piedras
Puerto Rico	Clinical Research Puerto Rico /ID# 211144	San Juan
United States	Anaheim Clinical Trials LLC /ID# 212559	Anaheim	California
United States	David Fivenson, MD, PLC /ID# 210193	Ann Arbor	Michigan
United States	Arlington Research Center, Inc /ID# 210344	Arlington	Texas
United States	Wallace Medical Group, Inc. /ID# 210403	Beverly Hills	California
United States	Total Skin and Beauty Derm Ctr /ID# 210366	Birmingham	Alabama
United States	Skin Care Research, LLC /ID# 210514	Boca Raton	Florida
United States	Treasure Valley Dermatology /ID# 212707	Boise	Idaho
United States	Clarkston Skin Research /ID# 210197	Clarkston	Michigan
United States	ACCEL Research Sites /ID# 212709	DeLand	Florida
United States	Henry Ford Medical Center /ID# 211598	Detroit	Michigan
United States	Psoriasis Treatment Ctr NJ /ID# 210837	East Windsor	New Jersey
United States	Palmetto Clinical Trial Services /ID# 210368	Fountain Inn	South Carolina
United States	Skin Laser and Surgery Specialists of NY and NJ /ID# 210208	Hackensack	New Jersey
United States	Center for Clinical Studies - Houston (Binz) /ID# 210361	Houston	Texas
United States	Clinical Partners, LLC /ID# 210642	Johnston	Rhode Island
United States	Cleaver Dermatology /ID# 210300	Kirksville	Missouri
United States	Multi-Speciality Research Associates /ID# 211625	Lake City	Florida
United States	Dermatology Res. Assoc., CA /ID# 210402	Los Angeles	California
United States	DS Research /ID# 210272	Louisville	Kentucky
United States	Forefront Dermatology /ID# 210520	Louisville	Kentucky
United States	GSI Clinical Research, LLC /ID# 210330	Margate	Florida
United States	Coastal Carolina Research Ctr /ID# 213069	Mount Pleasant	South Carolina
United States	Suncoast Clinical Research /ID# 210874	New Port Richey	Florida
United States	Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562	Normal	Illinois
United States	Lynn Health Science Institute (LHSI) /ID# 213216	Oklahoma City	Oklahoma
United States	Advanced Dermatology of the Midlands /ID# 212763	Omaha	Nebraska
United States	Skin Specialists, PC /ID# 211490	Omaha	Nebraska
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	The Indiana Clinical Trials Center /ID# 210205	Plainfield	Indiana
United States	Progressive Medical Research /ID# 210877	Port Orange	Florida
United States	Hull Dermatology, PA /ID# 210305	Rogers	Arkansas
United States	Integrative Skin Science and Research /ID# 212551	Sacramento	California
United States	Progressive Clinical Research /ID# 210359	San Antonio	Texas
United States	Mosaic Dermatology /ID# 210780	Santa Monica	California
United States	DermResearchCenter of NY, Inc. /ID# 210652	Stony Brook	New York
United States	Acclaim Dermatology /ID# 212252	Sugar Land	Texas
United States	Precision Clinical Research /ID# 212921	Sunrise	Florida
United States	Lenus Research & Medical Group /ID# 212584	Sweetwater	Florida
United States	WDC Cosmetic and Research, PLLC /ID# 210372	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to 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. Negative values indicate an improvement from baseline.	Baseline, Week 4, and Week 16
Primary	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. 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.	At Week 16
Primary	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
Secondary	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. 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.	At Week 16
Secondary	Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 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

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