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

NCT ID: NCT03875482

Last Updated: 2021-03-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2020-07-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Risankizumab

Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously

Placebo

Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16

Group Type PLACEBO_COMPARATOR

Placebo solution for risankizumab

Intervention Type DRUG

Placebo solution in prefilled syringes, self-administered subcutaneously

Interventions

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Risankizumab

Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously

Intervention Type DRUG

Placebo solution for risankizumab

Placebo solution in prefilled syringes, self-administered subcutaneously

Intervention Type DRUG

Other Intervention Names

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ABBV-066 BI 655066

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Total Skin and Beauty Derm Ctr /ID# 210366

Birmingham, Alabama, United States

Site Status

Alliance Dermatology and MOHs /ID# 210645

Phoenix, Arizona, United States

Site Status

Hull Dermatology, PA /ID# 210305

Rogers, Arkansas, United States

Site Status

Anaheim Clinical Trials LLC /ID# 212559

Anaheim, California, United States

Site Status

Wallace Medical Group, Inc. /ID# 210403

Beverly Hills, California, United States

Site Status

Dermatology Res. Assoc., CA /ID# 210402

Los Angeles, California, United States

Site Status

Integrative Skin Science and Research /ID# 212551

Sacramento, California, United States

Site Status

Mosaic Dermatology /ID# 210780

Santa Monica, California, United States

Site Status

Skin Care Research, LLC /ID# 210514

Boca Raton, Florida, United States

Site Status

ACCEL Research Sites /ID# 212709

DeLand, Florida, United States

Site Status

Multi-Speciality Research Associates /ID# 211625

Lake City, Florida, United States

Site Status

GSI Clinical Research, LLC /ID# 210330

Margate, Florida, United States

Site Status

Suncoast Clinical Research /ID# 210874

New Port Richey, Florida, United States

Site Status

Ormond Medical Arts Pharmaceutical Research Center /ID# 212781

Ormond Beach, Florida, United States

Site Status

Progressive Medical Research /ID# 210877

Port Orange, Florida, United States

Site Status

Precision Clinical Research /ID# 212921

Sunrise, Florida, United States

Site Status

Lenus Research & Medical Group /ID# 212584

Sweetwater, Florida, United States

Site Status

Treasure Valley Dermatology /ID# 212707

Boise, Idaho, United States

Site Status

Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562

Normal, Illinois, United States

Site Status

The Indiana Clinical Trials Center /ID# 210205

Plainfield, Indiana, United States

Site Status

Forefront Dermatology /ID# 210520

Louisville, Kentucky, United States

Site Status

DS Research /ID# 210272

Louisville, Kentucky, United States

Site Status

David Fivenson, MD, PLC /ID# 210193

Ann Arbor, Michigan, United States

Site Status

Clarkston Skin Research /ID# 210197

Clarkston, Michigan, United States

Site Status

Henry Ford Medical Center /ID# 211598

Detroit, Michigan, United States

Site Status

Cleaver Dermatology /ID# 210300

Kirksville, Missouri, United States

Site Status

Advanced Dermatology of the Midlands /ID# 212763

Omaha, Nebraska, United States

Site Status

Skin Specialists, PC /ID# 211490

Omaha, Nebraska, United States

Site Status

Psoriasis Treatment Ctr NJ /ID# 210837

East Windsor, New Jersey, United States

Site Status

Skin Laser and Surgery Specialists of NY and NJ /ID# 210208

Hackensack, New Jersey, United States

Site Status

DermResearchCenter of NY, Inc. /ID# 210652

Stony Brook, New York, United States

Site Status

WDC Cosmetic and Research, PLLC /ID# 210372

Wilmington, North Carolina, United States

Site Status

Lynn Health Science Institute (LHSI) /ID# 213216

Oklahoma City, Oklahoma, United States

Site Status

Clinical Partners, LLC /ID# 210642

Johnston, Rhode Island, United States

Site Status

Palmetto Clinical Trial Services /ID# 210368

Fountain Inn, South Carolina, United States

Site Status

Coastal Carolina Research Ctr /ID# 213069

Mt. Pleasant, South Carolina, United States

Site Status

Arlington Research Center, Inc /ID# 210344

Arlington, Texas, United States

Site Status

Center for Clinical Studies - Houston (Binz) /ID# 210361

Houston, Texas, United States

Site Status

Progressive Clinical Research /ID# 210359

San Antonio, Texas, United States

Site Status

Acclaim Dermatology /ID# 212252

Sugar Land, Texas, United States

Site Status

Dr. Samuel Sanchez, PSC /ID# 211142

Caguas, , Puerto Rico

Site Status

Pan American Center for Oncology Trials, LLC /ID# 212445

Rio Piedras, , Puerto Rico

Site Status

Clinical Research Puerto Rico /ID# 211144

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5.

Reference Type DERIVED
PMID: 33947295 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://rxabbvie.com

Related Info.

Other Identifiers

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M15-999

Identifier Type: -

Identifier Source: org_study_id

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